Home NDC 63868-119 Pain Relief PM
Product NDC 63868-119
11-digit product format 638680119
Labeler code 63868
Product ID 63868-119_68f2d380-71de-422f-808a-77316fcf3017
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-05-31
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pain Relief PM
Brand name suffix Extra Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-119-50 Pain Relief PMExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 7 63868-119-50 Pain Relief PMExtra Strength 1 in 1 BOX TABLET, COATED 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-119 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 7 Current NDC, Legacy NDC, 2 package rows 20240420_47660794-22cc-4863-a183-e694d27e3543.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63868-119-50 63868011950 1 BOTTLE, PLASTIC in 1 BOX (63868-119-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2015-05-31 0000-00-00 No No Current