McNeil Consumer Healthcare Company
`Worldwide Consumer Pharmaceutical Intranet Site
`Content
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`History of TYLENOL
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`Early Beginnings
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`McNeil: From Drug Store to Drug Development
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`On Monday, March 17, 1879, Robert McNeil paid $167 for a drugstore complete with
`fixtures, inventory and soda fountain, located in the heart of the mill district in
`Philadelphia, Pa. A 23-year-old graduate of the Philadelphia College of Pharmacy and
`Science, McNeil had wisely chosen a good location for his drugstore where potential
`customers and growth were assured. First day sales for his fledgling business totaled
`$5.79! This was the birth of future McNeil companies with a tradition of caring for
`others, service to the community, and the pursuit of excellence.
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`Robert McNeil's pharmacy rapidly became known as "The Largest Drug and Prescription
`Store Uptown" serving loyal neighborhood customers and physicians in the Kensington
`section of Philadelphia. In those days, the quality of pharmaceuticals was dependent upon
`a druggist's ability to select materials and his skill in making the finished product, using
`largely home-made equipment. Medications used by the medical profession were largely
`folklore products such as roots, barks, herbs and flowers.
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`McNeil quickly earned a reputation as a superior pharmacist. He used his signature blown
`in the side of his bottles as a means of assuring customers a product of quality up to "the
`McNeil standard."
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`Expanding the Business
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`In 1900, McNeil relocated his business to a larger four-story building with space for a
`sickroom supply department, a truss and bandage fitting room and research and
`manufacturing laboratories.
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`Four years later, McNeil's only son, Robert Lincoln McNeil (known as Lincoln) joined
`the family business. A graduate of the Wharton Business School, he assumed
`responsibility for McNeil's manufacturing lab and physician's supply business which
`grew rapidly. His father supervised the retail operations. In 1914, father and son officially
`formed a partnership known as the Firm of Robert McNeil.
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`When Robert McNeil retired in 1925, Lincoln made a strategic decision to discontinue
`the successful retail operations and focus on expanding the drug research and production
`side of the business. Once again, the business was relocated to a larger facility located
`near the railroads to facilitate service to an increasing number of out of state customers.
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`The new building was a model pharmaceutical plant designed for manufacturing products
`of the highest quality with the most modern equipment.
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`Focus on Physicians
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`After Robert McNeil's death in 1933, the company was incorporated under the name
`McNeil Laboratories, Inc. with Robert Lincoln McNeil serving as its first president.
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`Lincoln's eldest son, Robert Lincoln McNeil, Jr. (Bob), joined the company in 1938 after
`graduating from Yale University with a degree in physiological chemistry. As the first
`member of McNeil's research department, his primary focus was to analyze and trim the
`product line from 1,400 items to 100 quality items.
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` A
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` second son, Henry S. McNeil, joined the company in 1939. Also a Yale graduate with
`a degree in applied economic science, he focused on sales, converting the company's
`business from direct selling to "detailing" physicians, a new business approach that was
`very successful.
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`During the same period, McNeil introduced BUTISOL SODIUM, a daytime sedative
`which was the company's leading product from 1948 to 1969. It was the first McNeil
`product to reach $1 million in sales.
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`TYLENOL Launch and J&J Acquisition
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`In 1955, McNeil Laboratories introduced TYLENOL Elixir for Children, first in a line of
`products that was to become the nation's best selling analgesic. In the same year, Robert
`Lincoln McNeil retired. His sons, Henry and Bob, carried on as president and chairman
`of the board respectively.
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`By 1957, the company needed more space once again. McNeil acquired a 110-acre tract
`of land in Fort Washington, Pa. and construction of a new plant took place over the next
`four years.
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`In 1959, Johnson & Johnson acquired McNeil Laboratories. At the time, net sales were
`$11.4 million and the sales force numbered 225. The escalating cost of research was a
`primary factor in the decision to sell the privately held family company.
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`For more detailed information, go to McNeil: The Evolution of a Family Company.
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`To continue, go to APAP and the Development of TYLENOL.
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`Brand Essence Major Milestones Worldwide Expansion Future Expectations
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`APAP and the Development of TYLENOL
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`Evolution of a Name
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`TYLENOL is the brand name for a non-prescription analgesic (pain reliever) and
`antipyretic (fever reducer) manufactured by McNeil Consumer Healthcare. The active
`ingredient used in TYLENOL products is acetaminophen. The trademark TYLENOL was
`created by McNeil's professional sales team using some of the letters in the chemical
`name for acetaminophen:
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`N-aceTYL-p-aminophENOL (also referred to as APAP)
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`Discovery of Acetaminophen
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`The history of acetaminophen dates back to the latter part of the 19th century. The
`substance was first described in chemical literature in 1878. In 1886, Drs. Arnold Cahn
`and Paul Hepp of France were treating a patient suffering from intestinal parasites. They
`had been investigating naphthalene for its beneficial effect in the treatment of this
`problem. When their drug supply ran out, they ordered more from a local pharmacy. An
`inexperienced pharmacist mistakenly filled the prescription with acetanilide.
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`(Although discovered in 1852 by the French chemist Charles Gerhardt, acetanilide was
`still an obscure drug at this time.)
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`The physicians found that acetanilide produced marked fever reduction in one of their
`patients who, along with intestinal parasites, had a febrile disease. As Drs. Cahn and
`Hepp continued to prescribe acetanilide, they also noticed its analgesic properties.
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`It wasn't until 1899, however, that the relationship between acetaminophen and
`acetanilide was discovered by Karl Morner of Germany. He learned that acetanilide is
`metabolized in the body to become acetaminophen.
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`Ten years later, another German physician, Joseph Freiher von Mering, first synthesized
`acetaminophen. Although his research confirmed that the drug was effective against pain
`and fever, von Mering recommended extensive investigation into all analgesics and
`antipyretics.
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`Acetaminophen was not prescribed nor studied any further until 1949 when research on
`chemically related drugs revived interest in the compound. Modern research techniques
`and clinical use in England confirmed the effectiveness and safety of acetaminophen as a
`fever and pain reliever.
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`McNeil Seizes Opportunity
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`In the late 1940s, McNeil Laboratories, as the company was then known, had defined as a
`new product objective an analgesic which would be different, available for marketing and
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`prescription only. At about the same time, James Roth, M.D., a University of
`Pennsylvania Graduate School of Medicine gastroenterologist, was lecturing throughout
`the United States about the dangers of aspirin. Subsequently, he began advocating for
`APAP. Dr. Roth became a principal consultant to McNeil, contributing to the company's
`interest in the compound.
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`In 1951, the safety and efficacy of acetaminophen was described at a scientific
`symposium in New York City sponsored by the Institute for the Study of Analgesic and
`Sedative Drugs. According to the research reported at this symposium, acetaminophen
`was found to be as effective as aspirin for pain relief and fever reduction, but without the
`side effects of aspirin such as stomach irritation, gastrointestinal bleeding, and
`impairment of the blood to clot normally.
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`Convinced of the safety and efficacy of the drug, McNeil began its own extensive
`research on acetaminophen which confirmed the findings reported at the symposium.
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`McNeil's first use of APAP was as a component of the combination product, ALGOSON,
`an elixir which contained sodium butabarbital and acetaminophen. It was marketed in
`1953 as a prescription analgesic.
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`The Birth of TYLENOL
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`In the spring of 1955, McNeil introduced TYLENOL Elixir for Children, the company's
`first single ingredient acetaminophen product. The outstanding success of TYLENOL
`was attributed to a unique marketing strategy: to inform health care professionals of the
`undesirable effects of aspirin and ask them to recommend TYLENOL to patients
`susceptible to these effects.
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`Marketed directly to physicians and pharmacists as a prescription product by McNeil's
`pharmaceutical sales force, TYLENOL Elixir received widespread acceptance as a safe
`and effective alternative to aspirin for the temporary relief of pain and fever. Its success
`encouraged McNeil to develop other TYLENOL products.
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`To continue, go to Major Milestones.
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`Brand Essence Worldwide Expansion Future Expectation
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`Major Milestones
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`• 1955 Initial TYLENOL launch Children's TYLENOL Elixir -- as Rx.
`Children's TYLENOL Product Profile
`• 1957 Children's TYLENOL Drops launch as Rx.
`Worldwide Expansion Launch in Canada.
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`• 1959 Children's TYLENOL Elixir launches as OTC.
`Children's TYLENOL Drops launch as OTC.
`Johnson & Johnson acquires McNeil Laboratories.
`• 1961 Adult TYLENOL Regular Strength Tablets launch as OTC.
`Adult TYLENOL Product Profile
`McNeil moves to its current 110-acre Fort Washington facility.
`• 1963 TYLENOL with Codeine launches.
`• 1970 Worldwide Expansion -- Launch in Switzerland.
`Worldwide Expansion Launch in Thailand
`• 1972 Children's TYLENOL Chewable Tablets launch.
`Worldwide Expansion: Launch in Saudi Arabia.
`• 1975 Extra Strength TYLENOL Capsules** launch.
`TYLENOL products become the 5th best selling brand of analgesic in the U.S. Johnson
`& Johnson responds by creating the McNeil Consumer Products Division to manage its
`rapidly expanding OTC business.
`• 1976 Extra Strength TYLENOL Tablets launches.
`TYLENOL products become the #1 brand of OTC analgesic in the U.S. by July, one year
`after the formation of McNeil Consumer Products Division.
`• 1977 A family era comes to an end when Henry McNeil retires from the board of
`McNeil Laboratories due to illness.
`• 1978 Johnson & Johnson divides McNeil Laboratories into two separate companies:
`McNeil Consumer Products Company, responsible for all OTC products marketed
`directly to consumers and health care professionals; and McNeil Pharmaceutical, a
`prescription drug company.
`TYLENOL with Codeine becomes the most frequently prescribed brand name and the
`5th product in the U.S. ever to generate more than one million new prescriptions per
`month.
`Extra Strength TYLENOL Adult Liquid launches.
`• 1979 TYLENOL becomes the #1 best selling product in the health and beauty aid
`category, surpassing Crest toothpaste, the 18-year leader.
`Second TYLENOL manufacturing facility opens in Round Rock, Texas.
`• 1980 Worldwide Expansion: Launch in Philippines.
`Regular Strength TYLENOL Capsules** launch -- achieve the strongest retail sell-in in
`McNeil CPC history.
`TYLENOL advertising begins to feature the claim that TYLENOL is used more by
`hospitals than any other OTC pain reliever.
`• 1981 Worldwide Expansion: Launch in Caribbean.
`National expansion of McNeil's professional detailing force, visiting physicians and
`hospitals to detail Adult and Children's TYLENOL.
`• 1982 TYLENOL Sinus and Children's CoTYLENOL launch.
`Criminal tampering of Extra-Strength TYLENOL Capsules. - September 30 - Seven
`deaths result from cyanide-laced Extra-Strength Capsules in Chicago. McNeil initiates a
`national withdrawal of implicated batches of Extra-Strength Capsules.
`- October 7 - A copy-cat incident occurs in California involving Extra-Strength Capsules
`laced with strychnine. McNeil institutes an unprecedented nationwide withdrawal of all
`McNeil CPC capsule products not in blister packs. McNeil cooperates fully with the U.S.
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` KINDERFARMS Ex. 1016
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`FDA investigation and communicates openly with the news media.
`- November 11 - Less than six weeks after the tampering incidents, McNeil CPC
`reintroduces Extra-Strength TYLENOL Capsules in new triple safety-sealed tamper-
`resistant packaging.
`• 1983 Jr. Strength TYLENOL Caplets launch.
`• 1984 Extra Strength TYLENOL Caplets launch.
`• 1985 Regular Strength TYLENOL Caplets launch.
`• 1986 Worldwide Expansion: Launch in Portugal
`Criminal tampering of Extra Strength TYLENOL Capsules. J&J withdraws all OTC
`capsule products from the market.
`• 1988 Extra Strength TYLENOL Gelcaps launch, one of McNeil's most innovative
`dosage forms.
`Co-TYLENOL is re-named Adult TYLENOL Cold.
`• 1989 Worldwide Expansion: Launches in Australia, Mexico
`Adult TYLENOL Allergy Sinus launches.
`• 1990 Jr. Strength TYLENOL Chewables launch.
`• 1991 Adult TYLENOL Cough launches.
`• 1992 Adult TYLENOL PM Extra Strength Pain Reliever/Sleep Aid Caplets launch.
`• 1993 Adult TYLENOL Flu launches.
`• 1994 Worldwide Expansion: Launches in The Baltics, Korea; Re-launch in
`Philippines
`Children's TYLENOL Suspension Drops (Grape) launch.
`Children's TYLENOL Suspension Liquid (Cherry) launches.
`TYLENOL Extended Relief Caplets launch.
`• 1995 Worldwide Expansion: Launch in China.
`• 1998 Worldwide Expansion: Launch in Vietnam
`Launch in Argentina
`Adult TYLENOL Sore Throat launches.
`Adult TYLENOL Extended Relief is renamed TYLENOL Arthritis.
`• 1999 SIMPLY SLEEPfrom the makers of TYLENOL launches.
`• 2000 Worldwide Expansion: Launch in Japan.
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`Women's TYLENOL Caplets launch.
`AFLEXA from the makers of TYLENOL launches.
`SIMPLY products from the makers of TYLENOL launch exclusively at WAL*MART
`stores.
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`Brand Essence Early Beginnings Worldwide Expansion Future Expansion
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` KINDERFARMS Ex. 1016
` KINDERFARMS LLC. v. GENEXA INC.
` PGR2023-00051
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