Home NDC 70677-0064 Naproxen Sodium PM
Product NDC 70677-0064
11-digit product format 706770064
Labeler code 70677
Product ID 70677-0064_eb781b4d-79e1-48e2-b903-57b82e006bef
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 2018-12-31
Marketing end 2026-12-31
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
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 PM 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 70677-0064-1 Naproxen Sodium PM 20 in 1 BOTTLE, PLASTIC TABLET 20 4 70677-0064-1 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 70677-0064 NAPROXEN SODIUM PM (NAPROXEN SODIUM) TABLET [STRATEGIC SOURCING SERVICES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20221116_03a331d8-c957-4949-894f-51d9bd15e0d0.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 Marketing start Marketing end Sample Exclude flag Status 70677-0064-1 70677006401 1 BOTTLE, PLASTIC in 1 BOX (70677-0064-1) / 20 TABLET in 1 BOTTLE, PLASTIC 2018-12-31 2026-12-31 No No Current