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 22 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	01f41fae-4abb-4b96-ab09-a7d3dfc286cd	2026-01-26	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	ec4dbb71-b507-42a3-9b68-14d4b6621ec1	2026-01-23	Warnings	Exact identifier application number: M013
Adult Low Dose Aspirin	ASPIRIN	NCS HealthCare of KY, LLC dba Vangard Labs	9105eff0-1c22-4298-8ee5-9fb7a1de12f1	2026-01-23	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e	2026-01-22	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	17cfa99d-abb2-4d77-9e0e-e77109fbb61a	2026-01-21	Warnings	Exact identifier application number: M013
Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg	ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MG	Farmacias De Similares TX LLC	48ea0a2c-511b-4805-e063-6394a90a1225	2026-01-21	Warnings	Exact identifier application number: M013
childrens mapap	ACETAMINOPHEN	Major Pharmaceuticals	a1b0ccf0-cf24-4b34-b42a-aa1cc1e57f60	2026-01-20	Warnings	Exact identifier application number: M013
EXTRA STRENGTH ACETAMINOPHEN	ACETAMINOPHEN	WALGREENS CO.	9b756e4e-6c56-43aa-a5bc-5b649440e759	2026-01-20	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELIEVER PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	WALGREENS CO.	5a58d620-a0ec-48d7-92dd-3f3f78ec10ea	2026-01-20	Warnings	Exact identifier application number: M013
equate pain reliever	ACETAMINOPHEN	Wal-Mart Stores Inc	d4e438c6-80dd-4531-91e6-bc4ca7a8570f	2026-01-20	Warnings	Exact identifier application number: M013
Unishield Extra Strength Non-Aspirin	ACETAMINOPHEN	Unishield	ba0ec1eb-db85-6a7f-e053-2995a90aafe5	2026-01-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	HyVee Inc	24acd62f-72b1-418a-b733-7e4888f3c0a3	2026-01-16	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	dd8b13a5-07df-4cec-92c3-1a662b1e1a56	2026-01-16	Warnings	Exact identifier application number: M013
EXTRA STRENGTH HEADACHE RELIEF	ACETAMINOPHEN, ASPIRIN, CAFFEINE	WALGREENS	7d8f8389-730d-494e-a0af-5a91a3c99e17	2026-01-16	Warnings	Exact identifier application number: M013
TENSION HEADACHE RELIEF	ACETAMINOPHEN AND CAFFEINE	WALGREENS	54aff6a0-2778-472f-90ba-375d6bce6ee8	2026-01-16	Warnings	Exact identifier application number: M013
EXTRA STRENGTH HEADACHE RELIEF	ACETAMINOPHEN, ASPIRIN, CAFFEINE	WALGREENS	097fbab7-3886-4e75-b037-f03adcf3859f	2026-01-16	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALGREENS CO.	bdb09e15-8e17-4987-99d0-bab8856a2109	2026-01-16	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	HF Acquisition Co LLC, DBA HealthFirst	4870ff00-f727-814d-e063-6394a90a6c8e	2026-01-15	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	HyVee Inc	957b13a4-4086-459f-8fa0-9708b317fabe	2026-01-15	Warnings	Exact identifier application number: M013
Unisom PM Pain Nighttime Sleep Aid and Pain Reliever	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Chattem, Inc.	451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb	2026-01-14	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