Naproxen Sodium Diphenhydramine HCl

Product NDC: 0363-9766
11-digit product format: 003639766
Labeler code: 0363
Product ID: 0363-9766_bf8ff5f8-ac9f-5fe7-e053-2995a90a0e74
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: WALGREEN CO.
Application: ANDA213663
Marketing category: ANDA
Marketing start: 2021-06-19
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 220 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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	0363-9766		D	Discontinued by firm		2026-08-17
excluded package	package	0363-9766	0363-9766-08	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0363-9766		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-9766	0363-9766-08	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	25MG;220MG	TABLET / ORAL			2020-09-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0363-9766-08	2023-03-02	C162847	48780-1	f386c649-fbd7-0266-e053-dadaa90a7c1a	NAPROXEN SODIUM PM Naproxen Sodium & Diphenhydramine HCl Tablets 220mg/25mg (NSAID) Pain Reliever/Nighttime sleep aid Sleep aid plus 12 hours pain relieving
0363-9766-08	2023-01-30	C162847	48780-1	f386c649-fbd7-0266-e053-dadaa90a7c1a	NAPROXEN SODIUM PM Naproxen Sodium & Diphenhydramine HCl Tablets 220mg/25mg (NSAID) Pain Reliever/Nighttime sleep aid Sleep aid plus 12 hours pain relieving

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9766	NAPROXEN SODIUM DIPHENHYDRAMINE HCL (NAPROXEN SODIUM DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	3	Legacy NDC	20240202_bf8ff5f8-ac9e-5fe7-e053-2995a90a0e74.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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium Diphenhydramine HCL	NAPROXEN SODIUM DIPHENHYDRAMINE HCL	Walmart	fe810c0e-ab42-5a8a-e053-6394a90affe4	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213663 application number: ANDA213663
Naproxen Sodium and Diphenhydramine HCL	NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL	TARGET CORPORATION	fe82699d-fdc2-038e-e053-6294a90a606c	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213663 application number: ANDA213663
Naproxen Sodium Diphenhydramine HCl	NAPROXEN SODIUM DIPHENHYDRAMINE HCL	CVS PHARMACY, INC	bdac694e-ab2a-376d-e053-2a95a90a9467	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213663 application number: ANDA213663
Naproxen Sodium Diphenhydramine Hydrochloride	NAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDE	SAFEWAY	ed0f3275-f156-13a3-e053-2a95a90a2ce8	2025-12-18	Warnings	Exact identifier application applno (ANDA): 213663 application number: ANDA213663
Naproxen Sodium and Diphenhydramine HCl	NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL	Granules India Ltd	0d59780a-ef22-4b67-8b42-9795dbec8db0	2025-08-01	Warnings	Exact identifier application applno (ANDA): 213663 application number: ANDA213663

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-9766-08	00363976608	80 TABLET, FILM COATED in 1 BOTTLE (0363-9766-08)	2021-06-19	0000-00-00	No	No	Current