ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC: 65437-041
11-digit product format: 654370041
Labeler code: 65437
Product ID: 65437-041_13d391cd-6737-4d5d-a811-4cd602ec0013
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: HIMPRIT PHARMACHEM PVT LTD
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-07-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65437-041		I	Inactivated by FDA	2026-10-12
excluded package	package	65437-041	65437-041-31	I	Inactivated by FDA	2026-10-12
excluded package	package	65437-041	65437-041-50	I	Inactivated by FDA	2026-10-12

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 2 · 66 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	65437-041-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65437-041-50	`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	65437-041-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65437-041-50	`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	65437-041-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65437-041-50	`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	65437-041-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65437-041-50	`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	65437-041-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65437-041-50	`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	65437-041-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65437-041-50	`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	65437-041-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65437-041-50	`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	65437-041-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65437-041-50	`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	65437-041-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65437-041-50	`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	65437-041-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65437-041-50	`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	65437-041-31	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65437-041-50	`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	65437-041-31	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65437-041-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65437-041-31	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65437-041-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65437-041-31	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65437-041-50	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65437-041-31	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65437-041-50	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65437-041-31	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65437-041-50	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65437-041-31	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65437-041-50	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65437-041-31	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65437-041-50	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65437-041-31	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65437-041-50	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65437-041-31	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65437-041-50	`e2bbac7714bc…`	`27bdfed8d636…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65437-041-31	2020-01-31	C162847	48780-1	9d75b9d0-3010-f424-e053-dadaa90a57ce	ACETAINOPHEN AND DIPHENHYDRAMINE HCL TABLETS 500/25 mg
65437-041-50	2020-01-31	C162847	48780-1	9d75b9d0-3010-f424-e053-dadaa90a57ce	ACETAINOPHEN AND DIPHENHYDRAMINE HCL TABLETS 500/25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65437-041-31	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	31000 in 1 BAG	TABLET, FILM COATED	31000	1
65437-041-31	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	1 in 1 DRUM	TABLET, FILM COATED	1	1
65437-041-50	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	1 in 1 DRUM	TABLET, FILM COATED	1	1
65437-041-50	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	50000 in 1 BAG	TABLET, FILM COATED	50000	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65437-041	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	1	Legacy NDC, 4 package rows	20100701_6a2c1efb-d91b-48d2-b623-aa941e2c6f0e.zip

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	6a2c1efb-d91b-48d2-b623-aa941e2c6f0e	1
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	6a2c1efb-d91b-48d2-b623-aa941e2c6f0e	1
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	6a2c1efb-d91b-48d2-b623-aa941e2c6f0e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
65437-041-31	65437004131	31000 in 1 BAG	Historical
65437-041-50	65437004150	1 in 1 DRUM	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETAINOPHEN AND DIPHENHYDRAMINE HCL TABLETS 500/25 mg	HIMPRIT PHARMACHEM PVT LTD	2010-06-15	HUMAN OTC DRUG LABEL	1