Acetaminophen PM

Product NDC: 63868-210
11-digit product format: 638680210
Labeler code: 63868
Product ID: 63868-210_c2a91066-4981-42c6-9a60-0841c1c3d2af
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Diphenhydramine HCl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-12-17
Marketing end: 2026-12-31
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
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: Acetaminophen 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bbc704e5-79f6-4c72-846b-cc30c5c43cb4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-210-20	Acetaminophen PMExtra Strength	20 in 1 BOTTLE, PLASTIC	TABLET, COATED	20		14
63868-210-20	Acetaminophen PMExtra Strength	1 in 1 CARTON	TABLET, COATED	1		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-210-20	EA - Each	63868-210	7f0450ef-6371-4fd2-ab47-df20f9122de8	1	2022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-210	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]	13	Current NDC, Legacy NDC, 2 package rows	20250515_bbc704e5-79f6-4c72-846b-cc30c5c43cb4.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 65 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care acetaminophen pm	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Amazon.com Services LLC	64a0084a-e29e-4c1a-8704-13a3e1238f76	2024-07-17	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Walmart Inc.	152c013a-c81c-f8f9-e063-6294a90a9f23	2024-07-15	Warnings	Exact identifier application number: M013
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	5411544e-3c2d-4e42-e054-00144ff8d46c	2024-07-10	Warnings	Exact identifier application number: M013
good sense pain relief pm extra strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	L. Perrigo Company	b97c51ad-4953-4491-9ceb-395550eb5296	2024-07-10	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreens	065e6f1b-f68c-491a-a157-84961a07e3d9	2024-07-10	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreens	3b7b6725-2996-44d3-89a3-032384e7e2ce	2024-07-10	Warnings	Exact identifier application number: M013
equate pain and fever infants	ACETAMINOPHEN	Wal-Mart Stores Inc	8a152c8d-8ae0-4201-8bb9-7b22c3577415	2024-07-10	Warnings	Exact identifier application number: M013
Acetaminophen PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	WinCo Foods, LLC	3c57498c-86b0-4ba3-881e-c742a2e8ece5	2024-07-09	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	WinCo Foods, LLC	c358d1dd-9fcb-4d18-9521-8f898b98a732	2024-07-09	Warnings	Exact identifier application number: M013
Acetaminophen Regular Strength	ACETAMINOPHEN	WinCo Foods, LLC	15430025-f25e-4fe7-b1fe-4eda4684081a	2024-07-09	Warnings	Exact identifier application number: M013
Acetaminophen Easy Tabs Extra Strength	ACETAMINOPHEN	WinCo Foods, LLC	0631f003-4852-4034-a1c5-1552804b1660	2024-07-09	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Bryant Ranch Prepack	61ecf3c9-42fa-4ae4-bd3b-694090477b9a	2024-07-09	Warnings	Exact identifier application number: M013
Panadol Cold and Flu NonDrowsy	ACETAMINOPHEN AND PHENYLEPRINE HCL	Haleon US Holdings LLC	fa0ce51f-441d-4409-8617-b3402b00f187	2024-07-08	Warnings	Exact identifier application number: M013
Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	81d4e8f5-2f15-462b-be71-ef05f0b791ab	2024-07-05	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief	ACETAMINOPHEN	Bryant Ranch Prepack	31a97a6a-e5c8-429a-b497-330f0d84777d	2024-07-05	Warnings	Exact identifier application number: M013
pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	375b2142-3c89-469c-98fd-bd4b63aeaa11	2024-07-05	Warnings	Exact identifier application number: M013
Best Choice Effervescent Pain Reliever 36	ASPIRIN	VALU MERCHANDISERS COMPANY	12f1278e-88b6-0460-e063-6394a90abf0e	2024-07-03	Warnings	Exact identifier application number: M013
Topcare pain and fever	ACETAMINOPHEN	Topco Associates LLC	950b16d5-65db-402d-8ec6-eec9e1e174dd	2024-07-03	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	WALMART INC.	16d5b56f-7e56-0c91-e063-6394a90a4b8e	2024-07-03	Warnings	Exact identifier application number: M013
Acetaminophen and Diphenhydramine hydrochloride	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	16d5786c-2346-f970-e063-6394a90a0a8c	2024-07-03	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1092189	acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	bbc704e5-79f6-4c72-846b-cc30c5c43cb4	14
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	bbc704e5-79f6-4c72-846b-cc30c5c43cb4	14
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	bbc704e5-79f6-4c72-846b-cc30c5c43cb4	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-210-20	63868021020	1 BOTTLE, PLASTIC in 1 CARTON (63868-210-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC	2007-12-17	2026-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice 44-556 Delisted	CHAIN DRUG MARKETING ASSOCIATION INC \| LNK International, Inc.	2025-10-07	HUMAN OTC DRUG LABEL	14