naproxen sodium pm

Product NDC: 37808-264
11-digit product format: 378080264
Labeler code: 37808
Product ID: 37808-264_7f8e2c7c-648d-488d-bd75-b9f353ce0424
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine hydrochloride, naproxen sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H E B
Application: ANDA208499
Marketing category: ANDA
Marketing start: 2020-10-13
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active strength: 25; 220 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: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: naproxen sodium pm
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1
NAPROXEN SODIUM	220 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup
9TN87S3A3C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1550957	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4281faf5-7182-404f-9f53-3d9ea0354a18	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
37808-264-27	naproxen sodium pm	80 in 1 BOTTLE	TABLET, FILM COATED	80	5
37808-264-27	naproxen sodium pm	1 in 1 CARTON	TABLET, FILM COATED	1	5
37808-264-60	naproxen sodium pm	20 in 1 BOTTLE	TABLET, FILM COATED	20	5
37808-264-60	naproxen sodium pm	1 in 1 CARTON	TABLET, FILM COATED	1	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-264	NAPROXEN SODIUM PM (DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM) TABLET, FILM COATED [H E B]	4	Current NDC, Legacy NDC, 4 package rows	20240201_4281faf5-7182-404f-9f53-3d9ea0354a18.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 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1550957	diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral Tablet	PSN	4281faf5-7182-404f-9f53-3d9ea0354a18	5
1550957	diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet	SCD	4281faf5-7182-404f-9f53-3d9ea0354a18	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-264-27	37808026427	1 BOTTLE in 1 CARTON (37808-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2020-10-13	0000-00-00	No	No	Current
37808-264-60	37808026460	1 BOTTLE in 1 CARTON (37808-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2020-10-13	0000-00-00	No	No	Current