Acetaminophen and Diphenhydramine HCL

Product NDC: 21130-661
11-digit product format: 211300661
Labeler code: 21130
Product ID: 21130-661_4650a298-b556-8c7e-e063-6394a90a01db
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Diphenhydramine HCL
Dosage form: TABLET
Route: ORAL
Labeler: SAFEWAY
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-06-30
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE
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: 2026-12-31
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 and Diphenhydramine HCL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
DIPHENHYDRAMINE	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
8GTS82S83M	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
f18c1aa2-5f8b-5458-e053-2995a90ab947	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	SPL version
21130-661-10	Acetaminophen and Diphenhydramine HCL	100 in 1 BOTTLE	TABLET	100	7
21130-661-20	Acetaminophen and Diphenhydramine HCL	200 in 1 BOTTLE	TABLET	200	7
21130-661-24	Acetaminophen and Diphenhydramine HCL	24 in 1 BOTTLE	TABLET	24	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-661	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [SAFEWAY]	6	Current NDC, 3 package rows	20241218_f18c1aa2-5f8b-5458-e053-2995a90ab947.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 61 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Infants Pain and Fever	ACETAMINOPHEN	Walgreen Company	9e08eb38-7538-4fa0-a0e1-047ab6cb1680	2024-10-15	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	PUBLIX SUPER MARKETS INC	9e779cc6-4641-6132-e053-2a95a90a3493	2024-10-11	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	CHAIN DRUG CONSORTIUM	5c1a3081-ae25-4895-bf76-ebcbb9fc8072	2024-10-11	Warnings	Exact identifier application number: M013
Aspirin 81 MG	ASPIRIN	Meijer	b3e5711c-9529-4eec-871d-de8efa858b86	2024-10-11	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	MEIJER DISTRIBUTION INC	9586e830-a285-4a07-8b34-969875442348	2024-10-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	68a52858-35c5-402a-8ceb-8d8a7c1e5f6c	2024-10-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	5de40821-3218-4320-bf11-9493bf01d489	2024-10-11	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	475becec-1a56-4cfa-a0c5-562f8772adfb	2024-10-11	Warnings	Exact identifier application number: M013
Topcare Pain Relief	ACETAMINOPHEN	Topco Associates LLC	6036c15b-1168-4103-9471-6a74a2140e53	2024-10-10	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	46d9d8cd-e3db-492c-9386-7e8255beff64	2024-10-08	Warnings	Exact identifier application number: M013
dg health aspirin	ASPIRIN	Dolgencorp, LLC	0ab34dc7-0110-4fc3-ae53-234e7d7bca3c	2024-10-07	Warnings	Exact identifier application number: M013
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	19ba1fb6-22ea-488e-9e52-94c14ceb80d1	2024-10-07	Warnings	Exact identifier application number: M013
foster and thrive aspirin	ASPIRIN	Strategic Sourcing Services LLC	4d66a8a8-a1c1-4430-8845-21ae67700c39	2024-10-07	Warnings	Exact identifier application number: M013
leader aspirin	ASPIRIN	Cardinal Health 110, LLC. dba Leader	ca603b12-e0f7-4d79-8e0d-4651a788ba9b	2024-10-07	Warnings	Exact identifier application number: M013
foster and thrive aspirin	ASPIRIN	McKesson Medical-Surgical, Inc.	e9342478-93d6-45de-948f-f4162ee675b2	2024-10-07	Warnings	Exact identifier application number: M013
Maximum Strength Backache Relief	MAGNESIUM SALICYLATE	JHK DBA American Safety & First Aid	f8cbcd4e-cfad-4592-8774-52e681494c45	2024-10-07	Warnings	Exact identifier application number: M013
Alka-Seltzer Original Flavor	ALKA-SELTZER ORIGINAL FLAVOR	Navajo Manufacturing Company Inc.	f70875ab-241c-4876-e053-6294a90a8092	2024-10-03	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	Navajo Manufacturing Company Inc.	86b6ac01-3866-4cd8-a1be-9babb6ff311b	2024-10-02	Warnings	Exact identifier application number: M013
childrens pain relief	ACETAMINOPHEN	Publix Super Markets Inc	de7dd4dc-c5df-4cac-a83a-b21a7637f339	2024-10-02	Warnings	Exact identifier application number: M013
Good Neighbor Pharmacy childrens pain and fever	ACETAMINOPHEN	Amerisource Bergen	6ba153b7-9dc9-4e42-9176-13b3922268bd	2024-10-02	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
8GTS82S83M	DIPHENHYDRAMINE	58-73-1	DIPHENHYDRAMINE

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	f18c1aa2-5f8b-5458-e053-2995a90ab947	7
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	f18c1aa2-5f8b-5458-e053-2995a90ab947	7
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	f18c1aa2-5f8b-5458-e053-2995a90ab947	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
21130-661-10	21130066110	100 TABLET in 1 BOTTLE (21130-661-10)	100 tablet	2023-06-30	No	No	Current
21130-661-20	21130066120	200 TABLET in 1 BOTTLE (21130-661-20)	200 tablet	2023-06-30	No	No	Current
21130-661-24	21130066124	24 TABLET in 1 BOTTLE (21130-661-24)	24 tablet	2023-06-30	No	No	Current