signature care naproxen sodium pm

Product NDC: 21130-808
11-digit product format: 211300808
Labeler code: 21130
Product ID: 21130-808_62ae1f99-df76-4b36-a99c-75e9305be11c
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine hydrochloride, naproxen sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Safeway
Application: ANDA208499
Marketing category: ANDA
Marketing start: 2019-06-20
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	21130-808		D	Discontinued by firm	2026-08-03
excluded package	package	21130-808	21130-808-58	D	Discontinued by firm	2026-08-03
excluded package	package	21130-808	21130-808-71	D	Discontinued by firm	2026-08-03

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 · 10 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	21130-808-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21130-808-58	`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	21130-808-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21130-808-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21130-808-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21130-808-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21130-808-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21130-808-58	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	25MG;220MG	TABLET / ORAL			2019-05-10

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208499-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2019-05-10	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-808	SIGNATURE CARE NAPROXEN SODIUM PM (DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM) TABLET, FILM COATED [SAFEWAY]	5	Legacy NDC	20250209_ae48d1aa-2528-4e66-ad78-f2f10df42325.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
naproxen sodium pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	Meijer Distribution Inc	34d635f8-9703-4c29-92a5-85d3b47c4c93	2026-07-07	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
good sense naproxen sodium	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	L. Perrigo Company	f548aa3d-b35e-458a-9815-3595a451ab78	2026-05-11	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
ALL NIGHT PAIN RELIEF PM	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	Walgreen Company	43e4ed28-b1be-4548-86ac-f40f9f83f04e	2026-04-27	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
naproxen sodium pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	H E B	4281faf5-7182-404f-9f53-3d9ea0354a18	2026-02-12	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
topcare all night pain relief pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	Topco Associates LLC	a20f193e-4e64-400a-b605-df08026cb80b	2025-12-11	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
up and up naproxen sodium pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	Target Corporation	c0769941-bcf2-4237-b70c-a79089ad5335	2025-11-05	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
dg health naproxen sodium pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	Dolgencorp Inc	6c2c087c-e36d-4971-b977-d3cab6d6edee	2025-11-05	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
naproxen sodium pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	Kroger Company	d5dafdd0-968d-4ee6-9461-1f72d3255240	2025-07-10	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
NAPROXEN SODIUM PM	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	Safeway	60cb7b6e-f2d2-48ca-8db7-7124717735d5	2025-07-09	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
equaline naproxen sodium pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	United Natural Foods, Inc. dba UNFI	ed7bfa3f-4972-4ab6-9f0c-0873a11571a9	2025-06-04	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
basic care naproxen sodium pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	Amazon.com Services LLC	7beed9e7-816b-494b-93fa-9caf10aa3834	2024-01-24	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499
careone naproxen sodium pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	American Sales Company	16547905-59c0-4936-82e1-2d9f5935d8dd	2023-12-11	Warnings	Exact identifier application applno (ANDA): 208499 application number: ANDA208499

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-808-58	21130080858	1 BOTTLE in 1 CARTON (21130-808-58) > 40 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-06-20	0000-00-00	No	No	Current
21130-808-71	21130080871	1 BOTTLE in 1 CARTON (21130-808-71) > 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2022-06-13	0000-00-00	No	No	Current