NDC 50580-608

Tylenol PM Extra Strength

Acetaminophen And Diphenhydramine Hydrochloride

Tylenol PM Extra Strength is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen; Diphenhydramine Hydrochloride.

Product ID50580-608_3030f7a3-954d-4885-9ee5-add92619cfdd
NDC50580-608
Product TypeHuman Otc Drug
Proprietary NameTylenol PM Extra Strength
Generic NameAcetaminophen And Diphenhydramine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-07-11
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength500 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50580-608-01

1 BOTTLE in 1 CARTON (50580-608-01) > 24 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2016-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-608-06 [50580060806]

Tylenol PM Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-11

NDC 50580-608-02 [50580060802]

Tylenol PM Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-11

NDC 50580-608-05 [50580060805]

Tylenol PM Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-11

NDC 50580-608-01 [50580060801]

Tylenol PM Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-11

NDC 50580-608-03 [50580060803]

Tylenol PM Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2016-07-11

NDC 50580-608-04 [50580060804]

Tylenol PM Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-11

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:ce58105b-f010-47af-8f31-6dd4ce4e9cba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1092189
  • 1092378

    • NDC Crossover Matching brand name "Tylenol PM Extra Strength" or generic name "Acetaminophen And Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    67414-608Tylenol PM Extra StrengthTylenol PM Extra Strength
    0536-1003ACETA-GESICACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
    30142-193Acetaminophen and Diphenhydramine hydrochlorideAcetaminophen and Diphenhydramine hydrochloride
    49035-026ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE
    52204-124ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
    37012-771Acetaminophen PMAcetaminophen and Diphenhydramine Hydrochloride
    41163-515Acetaminophen PMAcetaminophen and Diphenhydramine Hydrochloride
    57344-095Acetaminophen PMAcetaminophen and DIPHENHYDRAMINE HYDROCHLORIDE
    30142-755Extra Strength Acetaminophen PMAcetaminophen and Diphenhydramine Hydrochloride
    21130-095Pain Relief PMAcetaminophen and Diphenhydramine Hydrochloride
    36800-095Pain Relief PMAcetaminophen and Diphenhydramine Hydrochloride
    36800-771Pain Relief PMAcetaminophen and Diphenhydramine Hydrochloride
    37808-795Pain Relief PMAcetaminophen and Diphenhydramine Hydrochloride
    41250-195pain relief PMAcetaminophen and Diphenhydramine Hydrochloride
    49738-783Pain Relief PMAcetaminophen and Diphenhydramine Hydrochloride
    50804-825Pain Relief PMAcetaminophen and Diphenhydramine Hydrochloride
    15127-033Pain Reliever PMAcetaminophen and Diphenhydramine Hydrochloride
    0031-8770Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttimeacetaminophen and diphenhydramine hydrochloride
    50405-007SohMed Pain Relief PMAcetaminophen and Diphenhydramine Hydrochloride
    49483-356TIME-GESICACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
    50580-608Tylenol PMacetaminophen and diphenhydramine hydrochloride
    50580-833TYLENOL PMAcetaminophen and Diphenhydramine Hydrochloride
    52904-945Tylenol PMacetaminophen and diphenhydramine hydrochloride
    41167-0040Unisom PM Pain Nighttime Sleep Aid and Pain RelieverAcetaminophen and Diphenhydramine Hydrochloride

    Trademark Results [Tylenol PM]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TYLENOL PM
    TYLENOL PM
    74143985 1777613 Live/Registered
    JOHNSON & JOHNSON
    1991-03-04
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