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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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 firm2026-07-31

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-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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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