Naproxen Sodium and Diphenhydramine HCl

Product NDC: 62207-814
11-digit product format: 622070814
Labeler code: 62207
Product ID: 62207-814_3b4ca636-ecbd-6807-e063-6294a90a7765
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium and Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Granules India Ltd
Application: ANDA213663
Marketing category: ANDA
Marketing start: 2021-02-20
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen Sodium and Diphenhydramine HCl
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9TN87S3A3C	Internal UNII lookup
TC2D6JAD40	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
0d59780a-ef22-4b67-8b42-9795dbec8db0	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
62207-814-38	Naproxen Sodium and Diphenhydramine HCl	37500 in 1 POUCH	TABLET, FILM COATED	37500	5
62207-814-39	Naproxen Sodium and Diphenhydramine HCl	7500 in 1 POUCH	TABLET, FILM COATED	7500	5
62207-814-47	Naproxen Sodium and Diphenhydramine HCl	500 in 1 BOTTLE	TABLET, FILM COATED	500	5
62207-814-95	Naproxen Sodium and Diphenhydramine HCl	20 in 1 BOTTLE	TABLET, FILM COATED	20	5
62207-814-95	Naproxen Sodium and Diphenhydramine HCl	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
62207-814	NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL TABLET, FILM COATED [GRANULES INDIA LTD]	4	Current NDC, Legacy NDC, 5 package rows	20230210_0d59780a-ef22-4b67-8b42-9795dbec8db0.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 ndc (product): 62207-814

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	0d59780a-ef22-4b67-8b42-9795dbec8db0	5
1550957	diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet	SCD	0d59780a-ef22-4b67-8b42-9795dbec8db0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62207-814-38	62207081438	37500 TABLET, FILM COATED in 1 POUCH (62207-814-38)		2021-02-20	0000-00-00	No	No	Current
62207-814-39	62207081439	7500 TABLET, FILM COATED in 1 POUCH (62207-814-39)		2021-02-20	0000-00-00	No	No	Current
62207-814-47	62207081447	500 TABLET, FILM COATED in 1 BOTTLE (62207-814-47)		2021-02-20	0000-00-00	No	No	Current
62207-814-95	62207081495	1 BOTTLE in 1 CARTON (62207-814-95) / 20 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-02-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen Sodium and Diphenhydramaine HCl Tablets	Granules India Ltd	2025-08-01	HUMAN OTC DRUG LABEL	5