Park, Davis & Co. Codeine Cough Sedative

TO:DOCKETS MANAGEMENT BRANCH
Food and Drug Administration
Department of Health and Human Services
12420 Parklawn Drive, Room 1-23
Rockville, MD 20857

PETITION and NOTICE OF EXEMPTION
The undersigned, Paul Klopper - doing business as Farmacy, and Dr. Tod Mikuriya, M.D. submit this petition and notice of exemption under 21 U.S.C. § 321(p) to request the Commissioner of Food and Drugs to issue a ruling that the products listed below are exempt from all of the new drug provisions of the act under the exemption for products marketed before June 25, 1938 (more commonly known as the "grand- father clause"). 21 CFR § 314.200(e)(2) ...

Attached hereto are copies of pertinent documents and records that establish the formulations, the uses, the labeling, and the marketing of the above identified products at the time of the initial marketing of those products. These documents and/or records are best summarized as follows:

Parke, Davis & Co.
From 1890 through 1937, the Parke, Davis & Company widely marketed various formulations of medical cannabis. The products and formulations were advertised as originating from "home-grown cannabis." Parke, Davis & Company marketed tinctures and fluid extracts sold by the pint or fluid ounce; cannabis tablets and pills sold by the gram; solid and powdered extracts sold by the gram, ounce, or pound; and "pressed flowering tops" also sold by the gram, ounce, or pound. Solid and powdered extracts along with "flowering tops" were sold to practitioners or ultimate users who wished to prepare their own tinctures, fluids, or tablets.

The advertised uses of these formulations include the following: analgesic, sedative, corn cures, spasmodic disorders, genito-urinary irritation, persistent cough, insomnia, hysteria, asthma, delirium tremens, acute fevers, cathartics, migraine, gastralgia, pruritus, neuralgia, and as a narcotic "used in place of opium." ....

Materia Medica and Pharmacology (1927)
This text details how to prepare the various extracts and lists cannabis use for "neuralgia, distressing cough, quiets tickling in throat"...

Pocket Therapeutics and Dose-Book (1910)
Notes cannabis is available in tinctures and extracts and also available is "cannabinon" - the "resin from Cannabis indica" and "cannabin tannas" - "a powdered prepared from Cannabis indica." The solid extract and the cannabinon and cannabin tannas are available by the gram. Uses include antispasmodic, anti neuralgic, anodyne, cough sedative in tuberculosis, and migraine or sick headache."

- from FDA Grandfather Clause Petition by Paul Klopper & Dr. Tod H. Mikuriya (May 1999)

More on marijuana as a cough and cold medicine.

Codeine Cough Sedative (Park, Davis & Co.)
Codeine Cough Sedative (Park, Davis & Co.) Label
ShareThis