Home NDC 62011-0396 Naproxen Sodium PM
Product NDC 62011-0396
11-digit product format 620110396
Labeler code 62011
Product ID 62011-0396_2f5ffa22-168c-43c9-b5fe-7e93f6c2aa1a
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler Strategic Sourcing Services LLC
Application ANDA209726
Marketing category ANDA
Marketing start 2019-01-31
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active strength 25 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 2023-12-31
Current FDA listing Historical FDA.report record 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62011-0396-1 Naproxen Sodium PM 20 in 1 BOTTLE, PLASTIC TABLET 20 4 62011-0396-1 Naproxen Sodium PM 1 in 1 BOX TABLET 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62011-0396 NAPROXEN SODIUM PM (NAPROXEN SODIUM) TABLET [STRATEGIC SOURCING SERVICES LLC] 3 Legacy NDC, 2 package rows 20221116_7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 62011-0396-1 62011039601 1 BOTTLE, PLASTIC in 1 BOX (62011-0396-1) > 20 TABLET in 1 BOTTLE, PLASTIC 2019-01-31 0000-00-00 No No Current