NDC 68210-1000

EXTRA STRENGTH ACETAMINOPHEN PM

Acetaminophen And Diphenhydramine Hydrochloride

EXTRA STRENGTH ACETAMINOPHEN PM is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Spirit Pharmaceutical Llc. The primary component is Acetaminophen; Diphenhydramine Hydrochloride.

Product ID68210-1000_677589b3-f800-ab54-e053-2a91aa0a6a4c
NDC68210-1000
Product TypeHuman Otc Drug
Proprietary NameEXTRA STRENGTH ACETAMINOPHEN PM
Generic NameAcetaminophen And Diphenhydramine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-08-12
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameSpirit Pharmaceutical LLC
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength500 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68210-1000-1

1 BOTTLE in 1 CARTON (68210-1000-1) > 100 TABLET in 1 BOTTLE
Marketing Start Date2016-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68210-1000-2 [68210100002]

EXTRA STRENGTH ACETAMINOPHEN PM TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-02-12

NDC 68210-1000-5 [68210100005]

EXTRA STRENGTH ACETAMINOPHEN PM TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-12

NDC 68210-1000-1 [68210100001]

EXTRA STRENGTH ACETAMINOPHEN PM TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-12

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:561c6387-969d-4c82-8623-87774dd2ae21
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1092189
    • UPC Code
  • 0032251237621

    • NDC Crossover Matching brand name "EXTRA STRENGTH ACETAMINOPHEN PM" or generic name "Acetaminophen And Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    30142-755Extra Strength Acetaminophen PMAcetaminophen and Diphenhydramine Hydrochloride
    68210-1000EXTRA STRENGTH ACETAMINOPHEN PMEXTRA STRENGTH ACETAMINOPHEN PM
    70000-0149Extra Strength Acetaminophen PMExtra Strength Acetaminophen PM
    62011-0025Extra Strength Acetaminophen PMExtra Strength Acetaminophen PM
    62011-0024Extra Strength Acetaminophen PMExtra Strength Acetaminophen PM
    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
    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
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