FDA.reportPublic FDA data

All Night Pain Relief PM

Product NDC
0363-0844
Requested package NDC
0363-0844-80
11-digit product format
003630844
Labeler code
0363
Product ID
0363-0844_022bd9fe-6d43-4ca8-8dd8-4ecb2c198a85
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA209726
Marketing category
ANDA
Marketing start
2018-12-31
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-08440363-0844-80DDiscontinued by firm2026-09-14

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM25MG;220MGTABLET / ORAL2018-10-23

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2384e616aacf4f…
2026-08-18 06:07:402026-07A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-233f01610625f2…
2019-09-15 20:21 UTC2019-09A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23f41ea6bd6efb…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0844-80EA - Each0363-0844a912c1e7-082a-4a87-8a0e-b76577fa48a712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0844ALL NIGHT PAIN RELIEF PM (NAPROXEN SODIUM) TABLET [WALGREENS]4Legacy NDC20250509_12ab219a-051c-4e54-98e1-32cb3689586e.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium PMNAPROXEN SODIUMStrategic Sourcing Services LLC7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba2025-08-20WarningsExact identifier
application applno (ANDA): 209726
application number: ANDA209726
Naproxen Sodium PMNAPROXEN SODIUMStrategic Sourcing Services LLC03a331d8-c957-4949-894f-51d9bd15e0d02025-08-20WarningsExact identifier
application applno (ANDA): 209726
application number: ANDA209726
Naproxen Sodium and Diphenhydramine HClNAPROXEN SODIUM AND DIPHENHYDRAMINEAmneal Pharmaceuticals NY LLCcaca14cf-95f2-4c60-8bba-2154b8f353a32023-12-30WarningsExact identifier
application applno (ANDA): 209726
application number: ANDA209726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0844-800036308448080 TABLET in 1 BOTTLE, PLASTIC (0363-0844-80) 80 tablet2018-12-310000-00-00NoNoCurrent