Home Applications 205352 Application 205352
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALEVE PM DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM TABLET;ORAL 25MG;220MG Yes 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 N205352-001 ALEVE PM DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205352-001 ALEVE PM 25MG;220MG TABLET / ORAL RLD, RS 2014-01-17 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM Bayer HealthCare LLC. 82891458-ab0d-459a-8602-dcebd22c3010 2025-12-04 Warnings Exact identifier application applno (NDA): 205352 application number: NDA205352 ndc (product): 0280-1200
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current 0280-1200 Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM Bayer HealthCare LLC. NDA Current