Acetaminophen and Diphenhydramine HCl

Product NDC: 0536-3479
11-digit product format: 005363479
Labeler code: 0536
Product ID: 0536-3479_74cea4c6-8712-428c-96af-dd9d85c77962
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Diphenhydramine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Rugby Laboratories Inc.
Application: part343
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-10-06
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 500 mg/1; mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0536-3479		D	Discontinued by firm		2026-10-05
excluded package	package	0536-3479	0536-3479-06	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0536-3479-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0536-3479-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0536-3479-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0536-3479-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0536-3479-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0536-3479-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0536-3479-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0536-3479-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0536-3479-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0536-3479-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0536-3479-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0536-3479-06	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-3479-06	EA - Each	0536-3479	b934d12c-32f5-4ff4-b8e6-48bbdf65a0e8	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [CARILION MATERIALS MANAGEMENT]	3

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	e7af7a8d-8a64-42ff-a120-114fb9451ee3	5
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	e7af7a8d-8a64-42ff-a120-114fb9451ee3	5
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	e7af7a8d-8a64-42ff-a120-114fb9451ee3	5

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Diphenhydramine HCl Captabs	Carilion Materials Management	2017-12-26	HUMAN OTC DRUG LABEL	5