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 31 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreen Company	b4d8860b-d72f-4789-945e-1c6420a8efab	2025-12-02	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	WALGREEN COMPANY	f7b304d8-e37c-4ac6-b4a2-1797b92cb832	2025-12-01	Warnings	Exact identifier application number: M013
Dye FreeInfants Pain and Fever	ACETAMINOPHEN	WALGREEN COMPANY	1a304570-88b6-4c16-a8b4-c064bfa5d95a	2025-12-01	Warnings	Exact identifier application number: M013
Walgreen Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALGREENS	b48d93fe-bb60-493f-8d1a-b2dc864203c4	2025-12-01	Warnings	Exact identifier application number: M013
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	WALGREEN CO.	6c4ab613-a587-4ec4-9986-f1d000bc2d23	2025-12-01	Warnings	Exact identifier application number: M013
WAG HBP Daytime and Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	ac2f9ce8-e402-4451-a412-e99248a6ecbe	2025-12-01	Warnings	Exact identifier application number: M013
Walgreen Day Time NightTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESIN	WALGREENS CO.	5505217a-9679-4668-bdab-5d4553a47c56	2025-12-01	Warnings	Exact identifier application number: M013
CAREALL Aspirin	ASPIRIN	New World Imports, Inc	58a371d4-1f00-4fda-8e08-80610c58505a	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Non Aspirin Extra Strength	ACETAMINOPHEN	New World Imports, Inc	da05a1a1-35b4-4787-8c56-12e369f18ff0	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	80a699b9-bf5c-4765-9e20-ccbc7e3ace7a	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	66244cdb-2680-4fa8-890d-32aefd490038	2025-12-01	Warnings	Exact identifier application number: M013
Family Wellness Childrens Pain Reliever 574	ACETAMINOPHEN	Family Dollar Services, Inc.	902c1136-04d2-41f0-81c6-412663cdf378	2025-12-01	Warnings	Exact identifier application number: M013
WalgreenChildrens Pain Fever	ACETAMINOPHEN	WALGREENS CO.	2f757cde-2604-4ca4-b54e-e444f3757cdd	2025-11-26	Warnings	Exact identifier application number: M013
Walgreen Childrens Pain plus Fever	ACETAMINOPHEN	WALGREENS CO.	29ca2855-3c07-435d-a8e1-2997fcedd088	2025-11-26	Warnings	Exact identifier application number: M013
Walgreens Childrens Cold plus Cough plus Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	8714d4e6-3a3b-48c8-8ac1-51b933a2ceac	2025-11-26	Warnings	Exact identifier application number: M013
Pain Reliever, 24/7 Life by 7-Eleven	ACETAMINOPHEN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	44828b89-2563-b233-e063-6294a90ab124	2025-11-26	Warnings	Exact identifier application number: M013
MEMBERS MARK ACETAMINOPHEN	ACETAMINOPHEN	Sam's West Inc	03e831d4-8060-4633-9d02-e77100063fb4	2025-11-26	Warnings	Exact identifier application number: M013
Childrens Pain and Fever Dissolve Packs	ACETAMINOPHEN	WALGREENS CO.	ea0f265f-7d64-4731-beda-0bb841dd1ad7	2025-11-25	Warnings	Exact identifier application number: M013
Sore Throat Logenzes Sore Throat	BENZOCAINE AND MENTHOL	ATLANTIC BIOLOGICALS CORP.	71a80e13-bda3-40fb-b4e7-45e9985e707c	2025-11-24	Warnings	Exact identifier application number: M013
better living brands childrens fever and pain reliver	ACETAMINOPHEN	BETTER LIVING BRANDS LLC	c13ced61-c491-4fc2-b83f-78c6d9ad8546	2025-11-20	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