NDC 68210-0099

EXTRA STRENGTH PAIN RELIEF PM

Acetaminophen And Diphenhydramine Hydrochloride

EXTRA STRENGTH PAIN RELIEF 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 ID68210-0099_699a18b4-acd9-3a29-e053-2991aa0a34f2
NDC68210-0099
Product TypeHuman Otc Drug
Proprietary NameEXTRA STRENGTH PAIN RELIEF PM
Generic NameAcetaminophen And Diphenhydramine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-04-10
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 68210-0099-2

1 BOTTLE in 1 CARTON (68210-0099-2) > 24 TABLET in 1 BOTTLE
Marketing Start Date2018-04-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68210-0099-2 [68210009902]

EXTRA STRENGTH PAIN RELIEF PM TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-11

NDC 68210-0099-3 [68210009903]

EXTRA STRENGTH PAIN RELIEF PM TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-11

NDC 68210-0099-5 [68210009905]

EXTRA STRENGTH PAIN RELIEF PM TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-12

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:e8f71439-5c07-44ab-9c4d-42ed41eb159a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1092189
  • NDC Crossover Matching brand name "EXTRA STRENGTH PAIN RELIEF PM" or generic name "Acetaminophen And Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    53943-024Extra Strength Pain Relief PMAcetaminophen 500mg Diphenhydramine HCl 25mg
    68210-0010EXTRA STRENGTH PAIN RELIEF PMEXTRA STRENGTH PAIN RELIEF PM
    68210-0099EXTRA STRENGTH PAIN RELIEF PMEXTRA STRENGTH PAIN RELIEF PM
    59726-360Extra Strength Pain Relief PMExtra Strength Pain Relief PM
    68210-4095EXTRA STRENGTH PAIN RELIEF PMEXTRA STRENGTH PAIN RELIEF 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
    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

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