Acetaminophen Diphenhydramine HCL

Product NDC: 0363-9664
11-digit product format: 003639664
Labeler code: 0363
Product ID: 0363-9664_46537594-decc-ce80-e063-6394a90aa159
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen Diphenhydramine HCL
Dosage form: TABLET
Route: ORAL
Labeler: WALGREENS CO.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-09-30
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: 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 Diphenhydramine HCL
Listing expiration: 2026-12-31

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
d92d97a8-0ee3-1206-e053-2a95a90a72a8	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
0363-9664-37	Acetaminophen Diphenhydramine HCL	375 in 1 BOTTLE	TABLET	375		7
0363-9664-60	Acetaminophen Diphenhydramine HCL	125 in 1 BOTTLE	TABLET	125		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9664	ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [WALGREENS CO.]	6	Current NDC, Legacy NDC, 2 package rows	20241220_d92d97a8-0ee3-1206-e053-2a95a90a72a8.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 73 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PANADOL	ACETAMINOPHEN	Haleon US Holdings LLC	95801755-db54-4ad7-bec1-52671914f6ca	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	01e7dddb-755c-4745-b701-edcdb6209064	2024-02-06	Warnings, Adverse reactions	Exact identifier application number: M013
PANADOL PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	fe7cd1f2-9b00-4ded-99c2-8a152c71093c	2024-02-06	Warnings, Adverse reactions	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	AptaPharma Inc.	9064943f-836f-4853-b6f2-2c4879941eeb	2024-02-02	Warnings	Exact identifier application number: M013
Quality Choice Effervescent Pain Relief	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	079af5d7-1be8-2a93-e063-6294a90a496d	2024-02-01	Warnings	Exact identifier application number: M013
MEDI-FIRST Non-Aspirin	ACETAMINOPHEN	Proficient Rx LP	4c84948d-3a95-4c53-8529-7e7b9d8bb6df	2024-02-01	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Proficient Rx LP	9c7d65e4-df2f-47c1-a185-66aaf19aad2b	2024-02-01	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Proficient Rx LP	57e4820c-b4eb-442e-9c49-93eedfbc5e5e	2024-02-01	Warnings	Exact identifier application number: M013
good sense aspirin	ASPIRIN	Proficient Rx LP	73013074-9c6e-43c7-acde-4d9d8ed0133d	2024-02-01	Warnings	Exact identifier application number: M013
MEDIQUE APAP Extra Strength	ACETAMINOPHEN	Proficient Rx LP	c466a07f-2339-4cf5-8377-e0f109649c52	2024-02-01	Warnings	Exact identifier application number: M013
Percogesic Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE	Medtech Products Inc.	2c5f1140-fb83-42c9-b0b1-5e2bd69340bb	2024-02-01	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Proficient Rx LP	3c7783a7-2b28-4968-b766-0a49dc70ce6d	2024-02-01	Warnings	Exact identifier application number: M013
Regular Strength Pain Relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	102bdcde-cb90-f248-e063-6394a90aac79	2024-01-30	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE	Haleon US Holdings LLC	61802b27-c9ec-4386-9d44-45e8b1e558b7	2024-01-28	Warnings	Exact identifier application number: M013
AGRIFEN	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	0fde22da-cdfc-36cc-e063-6294a90a3885	2024-01-26	Warnings	Exact identifier application number: M013
DOLODOL	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	e80536f1-92cc-5bb3-e053-2995a90a9540	2024-01-26	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	d913d11f-c7a1-49d2-a2d3-9a29fc032806	2024-01-18	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	64c28b38-23bb-4c7e-9c19-1d1f0d597528	2024-01-18	Warnings	Exact identifier application number: M013
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	e0dd4c04-6811-38a1-e053-2995a90aa3c9	2024-01-17	Warnings	Exact identifier application number: M013
Regular Strength Acetaminophen	ACETAMINOPHEN	CARDINAL HEALTH	bdf8c511-ce25-0e30-e053-2a95a90a33f6	2024-01-10	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	d92d97a8-0ee3-1206-e053-2a95a90a72a8	7
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	d92d97a8-0ee3-1206-e053-2a95a90a72a8	7
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	d92d97a8-0ee3-1206-e053-2a95a90a72a8	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-9664-37	00363966437	375 TABLET in 1 BOTTLE (0363-9664-37)	375 tablet	2024-07-13		No	No	Current
0363-9664-60	00363966460	125 TABLET in 1 BOTTLE (0363-9664-60)	125 tablet	2022-09-30	0000-00-00	No	No	Current