acetaminophen pm

Product NDC: 68196-556
11-digit product format: 681960556
Labeler code: 68196
Product ID: 68196-556_2b701514-75fd-46d0-95c2-0adc9e9a383f
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, diphenhydramine HCl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Sam's West Inc
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-12-17
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: acetaminophen 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

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
68196-556-54	acetaminophen pmextra strength	375 in 1 BOTTLE, PLASTIC	TABLET, COATED	375		14

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 [SAM'S WEST INC]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68196-556	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [SAM'S WEST INC]	13	Current NDC, Legacy NDC, 1 package rows	20240829_cff9a730-2241-4e4c-bf6b-a2fa895e2417.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 21 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care aspirin	ASPIRIN	Amazon.com Services LLC	265c7d85-a666-4234-9c30-ca8e31f4bcb8	2026-02-03	Warnings	Exact identifier application number: M013
GOODYS MAX	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Medtech Products Inc.	02b3a604-3f09-47e7-add1-b9038b3a268b	2026-02-02	Warnings	Exact identifier application number: M013
Nighttime Pain Reliever plus Sleep Aid	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	8dd85a6b-507c-4502-9e55-a40bdf21d379	2026-02-02	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Rite Aid Corporation	9a647967-f0c6-466e-be70-34fd3de0a803	2026-02-02	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Wal-Mart Stores Inc	72365264-f9c4-49f0-be64-73d95817d358	2026-02-02	Warnings	Exact identifier application number: M013
Acetaminophen 325mg	ACETAMINOPHEN	Marlex Pharmaceuticals Inc	4a18168c-dd36-8280-e063-6394a90a7e10	2026-02-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Marlex Pharmaceuticals Inc	4a183b7d-3a1e-5557-e063-6294a90a5493	2026-02-01	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELEIF	ACETAMINOPHEN	Strategic Sourcing Services, LLC	0392db17-c4f3-424b-9dee-549fc5df61c5	2026-01-29	Warnings	Exact identifier application number: M013
Regular Strength Pain Reliever	ACETAMINOPHEN	Strategic Sourcing Services, LLC	959db1b0-2d9f-4857-b475-0fa027365212	2026-01-29	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	Strategic Sourcing Services LLC	8acdbcf9-64a0-4dda-b60e-7e122254ecf3	2026-01-29	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	FOODHOLD U.S.A., LLC	bc19bd47-69ea-4bcc-8d28-c043c9d32513	2026-01-29	Warnings	Exact identifier application number: M013
Alka-Seltzer Pain Relief	ALKA-SELTZER PAIN RELIEF	Bayer HealthCare LLC.	4975f0ff-0480-7fca-e063-6294a90aef2f	2026-01-28	Warnings	Exact identifier application number: M013
Extra Strength Mini Softgels Pain Reliever	ACETAMINOPHEN	THE KROGER CO	b49aae4f-b040-44a0-be73-cdf45cf14d7e	2026-01-28	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	b25faa8c-2d13-450a-970f-81c17a633030	2026-01-28	Warnings	Exact identifier application number: M013
EXTRA STRENGTH ACETAMINOPHEN	ACETAMINOPHEN	Wal-Mart Stores Inc	a88eba4c-0701-4eec-9a24-a804186fbfd8	2026-01-27	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELIEVER PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	649e0dd8-ca79-4bf1-9c15-9db9f1d2f5bd	2026-01-27	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	4961695d-72f3-533a-e063-6294a90a5a29	2026-01-27	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	NuCare Pharmaceuticals, Inc.	4965fc33-f815-d49e-e063-6394a90a119c	2026-01-27	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	H E B	99699cd6-ba7d-4db0-9f0f-0f2c1a369138	2026-01-27	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WAL-MART STORES INC	383e104b-beb9-45f4-b546-af42fef7ccea	2026-01-26	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	cff9a730-2241-4e4c-bf6b-a2fa895e2417	14
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	cff9a730-2241-4e4c-bf6b-a2fa895e2417	14
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	cff9a730-2241-4e4c-bf6b-a2fa895e2417	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68196-556-54	68196055654	375 TABLET, COATED in 1 BOTTLE, PLASTIC (68196-556-54)	2007-12-17	0000-00-00	No	No	Current