Home NDC 69238-1422 Naproxen Sodium and Diphenhydramine HCl
Product NDC 69238-1422
11-digit product format 692381422
Labeler code 69238
Product ID 69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium and Diphenhydramine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA209726
Marketing category ANDA
Marketing start 2018-10-23
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 43 .
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 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM 25MG;220MG TABLET / ORAL 2018-10-23
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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;220MG TABLET / ORAL 2018-10-23 f41ea6bd6efb…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69238-1422-2 Naproxen Sodium and Diphenhydramine HCl 1 in 1 CARTON TABLET, FILM COATED 1 6 69238-1422-2 Naproxen Sodium and Diphenhydramine HCl 20 in 1 BOTTLE TABLET, FILM COATED 20 6 69238-1422-4 Naproxen Sodium and Diphenhydramine HCl 1 in 1 CARTON TABLET, FILM COATED 1 6 69238-1422-4 Naproxen Sodium and Diphenhydramine HCl 40 in 1 BOTTLE TABLET, FILM COATED 40 6 69238-1422-6 Naproxen Sodium and Diphenhydramine HCl 160 in 1 BOTTLE TABLET, FILM COATED 160 6 69238-1422-6 Naproxen Sodium and Diphenhydramine HCl 1 in 1 CARTON TABLET, FILM COATED 1 6 69238-1422-8 Naproxen Sodium and Diphenhydramine HCl 1 in 1 CARTON TABLET, FILM COATED 1 6 69238-1422-8 Naproxen Sodium and Diphenhydramine HCl 80 in 1 BOTTLE TABLET, FILM COATED 80 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1422 NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL (NAPROXEN SODIUM AND DIPHENHYDRAMINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] 6 Current NDC, Legacy NDC, 8 package rows 20231231_caca14cf-95f2-4c60-8bba-2154b8f353a3.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69238-1422-2 69238142202 1 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-10-23 0000-00-00 No No Current 69238-1422-4 69238142204 1 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-10-23 0000-00-00 No No Current 69238-1422-6 69238142206 1 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-10-23 0000-00-00 No No Current 69238-1422-8 69238142208 1 BOTTLE in 1 CARTON (69238-1422-8) / 80 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-10-23 0000-00-00 No No Current