FDA.reportPublic FDA data

Naproxen Sodium and Diphenhydramine HCl

Product NDC
62207-814
11-digit product format
622070814
Labeler code
62207
Product ID
62207-814_3b4ca636-ecbd-6807-e063-6294a90a7765
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium and Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Granules India Ltd
Application
ANDA213663
Marketing category
ANDA
Marketing start
2021-02-20
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

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
ndc (product): 62207-814

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium and 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
0d59780a-ef22-4b67-8b42-9795dbec8db0Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62207-814-38Naproxen Sodium and Diphenhydramine HCl37500 in 1 POUCHTABLET, FILM COATED375005
62207-814-39Naproxen Sodium and Diphenhydramine HCl7500 in 1 POUCHTABLET, FILM COATED75005
62207-814-47Naproxen Sodium and Diphenhydramine HCl500 in 1 BOTTLETABLET, FILM COATED5005
62207-814-95Naproxen Sodium and Diphenhydramine HCl20 in 1 BOTTLETABLET, FILM COATED205
62207-814-95Naproxen Sodium and Diphenhydramine HCl1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-814NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL TABLET, FILM COATED [GRANULES INDIA LTD]4Current NDC, Legacy NDC, 5 package rows20230210_0d59780a-ef22-4b67-8b42-9795dbec8db0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSN0d59780a-ef22-4b67-8b42-9795dbec8db05
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCD0d59780a-ef22-4b67-8b42-9795dbec8db05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62207-814-386220708143837500 TABLET, FILM COATED in 1 POUCH (62207-814-38) 2021-02-200000-00-00NoNoCurrent
62207-814-39622070814397500 TABLET, FILM COATED in 1 POUCH (62207-814-39) 2021-02-200000-00-00NoNoCurrent
62207-814-4762207081447500 TABLET, FILM COATED in 1 BOTTLE (62207-814-47) 2021-02-200000-00-00NoNoCurrent
62207-814-95622070814951 BOTTLE in 1 CARTON (62207-814-95) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-02-200000-00-00NoNoCurrent