Home NDC 63868-325 Pain Relief PM
Product NDC 63868-325
11-digit product format 638680325
Labeler code 63868
Product ID 63868-325_2435717d-bbb9-9e00-e063-6394a90a75ad
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Chain Drug Marketing Association
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-11-08
Marketing end 2026-11-30
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
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 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 63868-325-01 Pain Relief PMExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 6 63868-325-50 Pain Relief PMExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 6 63868-325-50 Pain Relief PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 6
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 AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-325 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 6 Current NDC, Legacy NDC, 3 package rows 20241013_475becec-1a56-4cfa-a0c5-562f8772adfb.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 6 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join childrens fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation a63727c3-64d8-4ae9-8da3-974cae6beed2 2026-07-24 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC e4a2566e-48ec-4602-87e3-143398d15f33 2026-07-24 Warnings Exact identifier application number: M013 infants fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation 920e7055-7ed1-4db4-9215-f8933078bb7b 2026-07-24 Warnings Exact identifier application number: M013 Dye Free Pain and Fever Childrens ACETAMINOPHEN Walgreens c6665c11-9a01-4472-a444-acadb1de0b69 2026-07-23 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 103d109d-f520-409c-8da2-eb6b0fbec891 2026-07-22 Warnings Exact identifier application number: M013 Tylenol PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Kenvue Brands LLC ce58105b-f010-47af-8f31-6dd4ce4e9cba 2026-07-22 Warnings Exact identifier application number: M013 GOOD SENSE INFANTS PAIN AND FEVER ACETAMINOPHEN L. Perrigo Company a7cc3964-e8fa-41da-89ca-b0d2aa80f2a7 2026-07-22 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Cardinal Health 107, LLC 7562f4e4-54fa-488c-a199-48ad2632e2a1 2026-07-21 Warnings Exact identifier application number: M013 Medline ACETAMINOPHEN Medline Industries, LP 4b1d7243-b943-4e2b-e063-6294a90a2c4e 2026-07-20 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN LEADER/ Cardinal Health 110, Inc. 7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d 2026-07-16 Warnings Exact identifier application number: M013 Rapidol 500 Extra Strength ACETAMINOPHEN Pharmadel LLC 1d9fa7ec-a509-28b2-e063-6294a90a7831 2026-07-16 Warnings Exact identifier application number: M013 equate pain relief ACETAMINOPHEN WALMART INC. 2f9b2550-5476-49ae-b741-54416a40bc29 2026-07-16 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL HyVee Inc 4f45a750-1220-4a81-801e-bf08c9d117d6 2026-07-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Dr. Reddy's Laboratories Inc. 9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f 2026-07-15 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Family Dollar, Inc. 3f182571-3212-eb29-e063-6294a90a9fa0 2026-07-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN DOLGENCORP, LLC 955484a6-2a7a-4b15-a9b4-e888ed5de04c 2026-07-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Geri-Care Pharmaceuticals, Corp 58941782-362d-4436-b365-e909bdbd29a2 2026-07-15 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Major Pharmaceuticals 44730dfb-5062-4015-924b-c30b6c2b19c2 2026-07-13 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Cardinal Health 110, LLC. DBA Leader f1cd0d59-12a8-4ff2-942a-6faa6907ef05 2026-07-13 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Amerisource Bergen 2c5e80e8-a979-45fb-9297-8ff294280c25 2026-07-13 Warnings Exact identifier application number: M013
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 63868-325-01 63868032501 100 TABLET, COATED in 1 BOTTLE, PLASTIC (63868-325-01) 2007-11-08 2026-11-30 No No Current 63868-325-50 63868032550 1 BOTTLE, PLASTIC in 1 CARTON (63868-325-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2007-11-08 2026-11-30 No No Current