FDA.reportPublic FDA data

Naproxen Sodium Diphenhydramine HCl

Product NDC
0363-9766
Requested package NDC
0363-9766-08
11-digit product format
003639766
Labeler code
0363
Product ID
0363-9766_bf8ff5f8-ac9f-5fe7-e053-2995a90a0e74
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA213663
Marketing category
ANDA
Marketing start
2021-06-19
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
220 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage0363-97660363-9766-08DDiscontinued by firm2026-08-03

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
A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM25MG;220MGTABLET / ORAL2020-09-24

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 22:54:322026-06A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium Diphenhydramine HCLNAPROXEN SODIUM DIPHENHYDRAMINE HCLWalmartfe810c0e-ab42-5a8a-e053-6394a90affe42025-12-19WarningsExact identifier
application applno (ANDA): 213663
application number: ANDA213663
Naproxen Sodium and Diphenhydramine HCLNAPROXEN SODIUM AND DIPHENHYDRAMINE HCLTARGET CORPORATIONfe82699d-fdc2-038e-e053-6294a90a606c2025-12-19WarningsExact identifier
application applno (ANDA): 213663
application number: ANDA213663
Naproxen Sodium Diphenhydramine HClNAPROXEN SODIUM DIPHENHYDRAMINE HCLCVS PHARMACY, INCbdac694e-ab2a-376d-e053-2a95a90a94672025-12-19WarningsExact identifier
application applno (ANDA): 213663
application number: ANDA213663
Naproxen Sodium Diphenhydramine HydrochlorideNAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDESAFEWAYed0f3275-f156-13a3-e053-2a95a90a2ce82025-12-18WarningsExact identifier
application applno (ANDA): 213663
application number: ANDA213663
Naproxen Sodium and Diphenhydramine HClNAPROXEN SODIUM AND DIPHENHYDRAMINE HCLGranules India Ltd0d59780a-ef22-4b67-8b42-9795dbec8db02025-08-01WarningsExact identifier
application applno (ANDA): 213663
application number: ANDA213663

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-9766-082023-03-02C16284748780-1f386c649-fbd7-0266-e053-dadaa90a7c1aNAPROXEN SODIUM PM Naproxen Sodium & Diphenhydramine HCl Tablets 220mg/25mg (NSAID) Pain Reliever/Nighttime sleep aid Sleep aid plus 12 hours pain relieving
0363-9766-082023-01-30C16284748780-1f386c649-fbd7-0266-e053-dadaa90a7c1aNAPROXEN SODIUM PM Naproxen Sodium & Diphenhydramine HCl Tablets 220mg/25mg (NSAID) Pain Reliever/Nighttime sleep aid Sleep aid plus 12 hours pain relieving

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9766NAPROXEN SODIUM DIPHENHYDRAMINE HCL (NAPROXEN SODIUM DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]3Legacy NDC20240202_bf8ff5f8-ac9e-5fe7-e053-2995a90a0e74.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9766-080036397660880 TABLET, FILM COATED in 1 BOTTLE (0363-9766-08) 2021-06-190000-00-00NoNoCurrent