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OTC Panel Submissions (Indices Only): 05 - Sleep-Aids

OTC Sedatives, Tranquilizers and Sleep Aids Review Panel Index to Data Submissions
Volume Submitted By Trade Name Ingredients Remarks
050001 Monsanto Co. None

Methapyrilene HCl

Methapyrilene Fumarate

Bulk Chemical

Bulk Chemical

050002 FDA (Portland Retail Druggist Association) None Miscellaneous Documents from FDA files - Originally Submitted to DESI Study  

050003

(Box A)

J. B. Williams Co. Sominex Tablets

Scopolamine Aminoxide HBr.

Methapyrilene HCl

Salicylamide

Submitted loose in boxes at Firms request

050004

(Box B)

  Sominex Tablets

Scopolamine Aminoxide Hbr

Methapyrilene Hcl

Salicylamide

 
050005 Whitehall  Labs. Inc. Quiet World

Acetaminophen

Aspirin

Methapyrilene Hcl

Scopolamine Hbr.

 
050006 Whitehall  Labs. Sleep-eze

Methapyrilene HCl

Scopolamine HBr

 
050007 Block Drug Co.

Nytol Tablets

Nytol Capsules

Methapyrilene HCl

Scopolamine HBr

Methapyrilene HCl

Salicylamide

 

050008

050009

Jeffrey Martin Inc. Compoz Tablets

Pyrilamine maleate

Methapyrilene HCl

Scopolamine aminoxide HBr.

 
050010 FDA (Dr. Chernov)     Selected articles and papers
050011 FDA (Medical Library)     FDA Library Search Abstracts
050012 FDA (OTC Staff)     A Study of Health Practices and Opinions Final Report FDA Contract No. 66-193, June, 1972
050013 FDA (OTC Staff)   Methapyrilene HCL Drug Efficacy Study (NAS?NRC) Reports only one drug was covered, DORMIN
050014 Miles Labs. Miles Nervine

Sodium bromide

Potassium bromide

Ammonium bromide

 
050016 FDA (Dr. Chernov)   Scopolamine Paper titled “Proprietary Hallucinogens” by Leff and Bernstein
050017 FDA (Medical Library)   Salicylamide Limited literature search and bibliography on Salicylamide with selected articles
050018 Dr. Hartmann     Selected Papers by Dr. Hartmann submitted to the other Panel members at his request
050019 Jeffrey martin Inc. Compoz Tablets   Amendment to previous submission (050008) “Appropriate and Inappropriate Methodology in the evaluation of OTC Daytime Sedatives
050020 Jeffrey Martin Inc. Compoz Tablets   (More legible copy of Submission No. 050009)
050021 J. B. Williams Co.     Data on sedative properties of DOXYLAMINE and PHENYLTOLOXAMINE
050022 Miles labs. None

Diphenhydramine

Hydrochloride

Data on the use of this agent as a sedative-sleep aid

050023

050024

Bristol-Myers Excedrin P.M.

Aspirin

Salicylamide

Acetaminophen

Methapyrilene furmarate

 
050025 FDA     Adverse Reactions Data on Bromides, Scopolamino Compoz and Sominex requested by Panel
050026 Miles Labs. None

Diphenhydramine

Hydrochloride

Additional data submitted at Panel’s request
050027 Bristol-Myers     Additional data on Methapyrilene/Excedrin P.M.
050028 Parke Davis  

Bendryl

Diphenhybromide

 
050029 Dr. Norris     Toxicity Data
050030 FDA     Labeling information request by Panel
050031 Endo. Labs. Percogesic Dilone

Acetaminophen

Phenyltoloxamine acetate

Caffeine

 
050032 Bristol-Myers Excedrin P.M.   Additional Data
050033 Bristol-Myers Excedrin P.M.   Additional Data
050034 Bristol-Myers Excedrin P.M.  

Additional Submission

(Excedrin P.M.)

050035 Parke Davis   Benadryl  
050036 Jeffrey Martin Compoz   Comments on Daytime Sedatives
050037 Parke Davis  

Diphenhydramine

(Bendryl)

Additional data
050038 Endo Labs.     Additional information on percogesic
050039 Parke Davis     Study plan for Diphenhydramine
050040 J.B. Williams     Additional comments on Dr. Rickels study of Compoz
050041

Whitehall  Labs.

Division of American

Home Products

  Diphenhydramine Additional data
050042

Whitehall  Labs.

Division of American

Home Products

  Diphenhydramine Data requestred by Panel
050043 Sedative Panel Working Papers      
050044

Del  Labs. Inc.

Parmingdale,  N.Y. 

Placin Calmative

Capsules

Paminobenzoic Acid

Salicylamide

Passiflora (Passion Flower) P.E.

Euphorbia P.E.

 
050045

Johnson and Johnson Co.

New Brunswick, N.J. 

    Safety data on talc
050046 American Home Products Corp.     Target population for Daytime Sadatives
050047 Lemming-Pacquin     Comments on Doxylamine Succinate
050048 FDA     Hypnotic Testing guidelines
050049       Referenences - Nighttime Sleep-Aids, Daytime Sedatives, Stimulants A-E
050050       References - Nighttime Sleep-Aids, Daytime Sedatives, Stimulants F -K
050051       References - Nighttime Sleep-Aids, Daytime Sedatives, Stimulants L-R
050052       References - Nighttime Sleep-Aids, Daytime Sedatives, Stimulants S-Z
050053     Scopolamine References - (uncited)
050054     Scopolamine References - (uncited)
050055     Miscellaneous References - (uncited)

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