Application 208499

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	TABLET;ORAL	25MG;220MG	No	No

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…`

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 ndc (product): 41250-526
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 ndc (product): 0113-8264
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 ndc (product): 37808-264
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 ndc (product): 36800-264
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 ndc (product): 11673-687
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 ndc (product): 55910-858
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 ndc (product): 30142-753
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 ndc (product): 41163-593
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 ndc (product): 72288-310
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 ndc (product): 41520-264

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-7264	basic care naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	L. Perrigo Company	ANDA	Current
0113-8264	good sense naproxen sodium	diphenhydramine hydrochloride, naproxen sodium	L. Perrigo Company	ANDA	Current
0113-8264	good sense naproxen sodium	diphenhydramine hydrochloride, naproxen sodium	L. Perrigo Company	ANDA	Current
0113-8264	good sense naproxen sodium	diphenhydramine hydrochloride, naproxen sodium	L. Perrigo Company	ANDA	Current
0113-8264	good sense naproxen sodium	diphenhydramine hydrochloride, naproxen sodium	L. Perrigo Company	ANDA	Current
11673-687	up and up naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Target Corporation	ANDA	Current
21130-808	signature care naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Safeway	ANDA	Current
21130-808	signature care naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Safeway	ANDA	Current
21130-808	signature care naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Safeway	ANDA	Current
30142-383	naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Kroger Company	ANDA	Current
30142-383	naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Kroger Company	ANDA	Current
30142-753	naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Kroger Company	ANDA	Current
30142-753	naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Kroger Company	ANDA	Current
30142-753	naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Kroger Company	ANDA	Current
36800-264	topcare all night pain relief pm	diphenhydramine hydrochloride, naproxen sodium	Topco Associates LLC	ANDA	Current
36800-264	topcare all night pain relief pm	diphenhydramine hydrochloride, naproxen sodium	Topco Associates LLC	ANDA	Current
36800-264	topcare all night pain relief pm	diphenhydramine hydrochloride, naproxen sodium	Topco Associates LLC	ANDA	Current
37808-264	naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	H E B	ANDA	Current
37808-264	naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	H E B	ANDA	Current
41163-593	equaline naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Supervalu Inc	ANDA	Current
41163-593	equaline naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Supervalu Inc	ANDA	Current
41163-593	equaline naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Supervalu Inc	ANDA	Current
41250-526	naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Meijer Distribution Inc	ANDA	Current
41250-526	naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Meijer Distribution Inc	ANDA	Current
41520-264	careone naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	American Sales Company	ANDA	Current
41520-264	careone naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	American Sales Company	ANDA	Current
49035-727	equate all night pain relief	diphenhydramine hydrochloride, naproxen sodium	Wal-Mart Stores Inc	ANDA	Current
49035-727	equate all night pain relief	diphenhydramine hydrochloride, naproxen sodium	Wal-Mart Stores Inc	ANDA	Current
55910-858	dg health naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Dolgencorp, LLC	ANDA	Current
55910-858	dg health naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Dolgencorp, LLC	ANDA	Current
72288-310	basic care naproxen sodium pm	diphenhydramine hydrochloride, naproxen sodium	Amazon.com Services LLC	ANDA	Current