FDA.reportPublic FDA data

Naproxen Sodium Diphenhydramine HCl

Product NDC
69842-328
11-digit product format
698420328
Labeler code
69842
Product ID
69842-328_46540a23-aad6-6637-e063-6394a90a569e
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
ANDA213663
Marketing category
ANDA
Marketing start
2021-05-14
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
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage69842-32869842-328-08DDiscontinued 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
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
ndc (product): 69842-328
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

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium Diphenhydramine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM25 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE220 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9TN87S3A3CInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1550957Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bdac694e-ab2a-376d-e053-2a95a90a9467Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-328-022023-03-02C16284748780-1f386c64a-066c-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
69842-328-082023-03-02C16284748780-1f386c64a-066c-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
69842-328-022023-01-30C16284748780-1f386c64a-066c-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
69842-328-082023-01-30C16284748780-1f386c64a-066c-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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-328-02Naproxen Sodium Diphenhydramine HCl20 in 1 BOTTLETABLET, FILM COATED207
69842-328-08Naproxen Sodium Diphenhydramine HCl80 in 1 BOTTLETABLET, FILM COATED807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-328NAPROXEN SODIUM DIPHENHYDRAMINE HCL (NAPROXEN SODIUM DIPHENHYDRAMINE HCL) TABLET, FILM COATED [CVS PHARMACY, INC]5Current NDC, Legacy NDC, 2 package rows20241120_bdac694e-ab2a-376d-e053-2a95a90a9467.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSNbdac694e-ab2a-376d-e053-2a95a90a94677
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCDbdac694e-ab2a-376d-e053-2a95a90a94677

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-328-026984203280220 TABLET, FILM COATED in 1 BOTTLE (69842-328-02) 2021-05-140000-00-00NoNoCurrent
69842-328-086984203280880 TABLET, FILM COATED in 1 BOTTLE (69842-328-08) 2021-05-140000-00-00NoNoCurrent