Home NDC 0280-1200 Aleve PM
Product NDC 0280-1200
11-digit product format 002801200
Labeler code 0280
Product ID 0280-1200_45265ccc-d985-a6ad-e063-6394a90a75b7
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bayer HealthCare LLC.
Application NDA205352
Marketing category NDA
Marketing start 2014-09-09
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 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…
Additional Listing Data#
Finished product Yes
Brand name base Aleve PM
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1550957 Internal RxNorm lookup 1550963 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 0280-1200-01 Aleve PM 120 in 1 BOTTLE TABLET, FILM COATED 120 16 0280-1200-01 Aleve PM 1 in 1 CARTON TABLET, FILM COATED 1 16 0280-1200-02 Aleve PM 2 in 1 POUCH TABLET, FILM COATED 2 16 0280-1200-03 Aleve PM 160 in 1 BOTTLE TABLET, FILM COATED 160 16 0280-1200-04 Aleve PM 1 in 1 CARTON TABLET, FILM COATED 1 16 0280-1200-04 Aleve PM 40 in 1 BOTTLE TABLET, FILM COATED 40 16 0280-1200-05 Aleve PM 80 in 1 BOTTLE TABLET, FILM COATED 80 16 0280-1200-08 Aleve PM 250 in 1 BOTTLE TABLET, FILM COATED 250 16 0280-1200-08 Aleve PM 1 in 1 CARTON TABLET, FILM COATED 1 16 0280-1200-20 Aleve PM 1 in 1 CARTON TABLET, FILM COATED 1 16 0280-1200-20 Aleve PM 20 in 1 BOTTLE TABLET, FILM COATED 20 16 0280-1200-40 Aleve PM 1 in 1 CARTON TABLET, FILM COATED 1 16 0280-1200-40 Aleve PM 40 in 1 BOTTLE TABLET, FILM COATED 40 16 0280-1200-80 Aleve PM 80 in 1 BOTTLE TABLET, FILM COATED 80 16 0280-1200-80 Aleve PM 1 in 1 CARTON TABLET, FILM COATED 1 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE CONSUMER CARE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-1200 ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM) TABLET, FILM COATED [BAYER HEALTHCARE LLC.] 15 Current NDC, Legacy NDC, 15 package rows 20241210_82891458-ab0d-459a-8602-dcebd22c3010.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 · 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
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 0280-1200-01 00280120001 1 BOTTLE in 1 CARTON (0280-1200-01) / 120 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2014-09-09 0000-00-00 No No Current 0280-1200-02 00280120002 2 TABLET, FILM COATED in 1 POUCH (0280-1200-02) 2014-09-09 0000-00-00 No No Current 0280-1200-03 00280120003 160 TABLET, FILM COATED in 1 BOTTLE (0280-1200-03) 2014-09-09 0000-00-00 No No Current 0280-1200-04 00280120004 1 BOTTLE in 1 CARTON (0280-1200-04) / 40 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2014-09-09 0000-00-00 No No Current 0280-1200-05 00280120005 80 TABLET, FILM COATED in 1 BOTTLE (0280-1200-05) 2014-09-09 0000-00-00 No No Current 0280-1200-08 00280120008 1 BOTTLE in 1 CARTON (0280-1200-08) / 250 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-07-01 0000-00-00 No No Current 0280-1200-20 00280120020 1 BOTTLE in 1 CARTON (0280-1200-20) / 20 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2014-09-09 0000-00-00 No No Current 0280-1200-40 00280120040 1 BOTTLE in 1 CARTON (0280-1200-40) / 40 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2014-09-09 0000-00-00 No No Current 0280-1200-80 00280120080 1 BOTTLE in 1 CARTON (0280-1200-80) / 80 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2014-09-09 0000-00-00 No No Current