naproxen sodium diphenhydramine hcl (69842-328)

Drug Facts

Product Profile

Brand Name naproxen sodium diphenhydramine hcl

Generic Name naproxen sodium diphenhydramine hcl

Labeler cvs pharmacy, inc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

diphenhydramine hydrochloride 25 mg/1, naproxen sodium 220 mg/1

Manufacturer

CVS PHARMACY, INC

Identifiers & Regulatory

Product NDC 69842-328

Product ID 69842-328_46540a23-aad6-6637-e063-6394a90a569e

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA213663

Listing Expiration 2026-12-31

Marketing Start 2021-05-14

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69842328

Hyphenated Format 69842-328

Supplemental Identifiers

RxCUI

1550957

UNII

TC2D6JAD40 9TN87S3A3C

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name naproxen sodium diphenhydramine hcl (source: ndc)

Generic Name naproxen sodium diphenhydramine hcl (source: ndc)

Application Number ANDA213663 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
220 mg/1

source: ndc

Packaging

20 TABLET, FILM COATED in 1 BOTTLE (69842-328-02)

source: ndc

Packages (1)

69842-328-02 20 TABLET, FILM COATED in 1 BOTTLE (69842-328-02)

Ingredients (2)

diphenhydramine hydrochloride (25 mg/1) naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Naproxen Sodium Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "46540a23-aad6-6637-e063-6394a90a569e", "openfda": {"unii": ["TC2D6JAD40", "9TN87S3A3C"], "rxcui": ["1550957"], "spl_set_id": ["bdac694e-ab2a-376d-e053-2a95a90a9467"], "manufacturer_name": ["CVS PHARMACY, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (69842-328-02)", "package_ndc": "69842-328-02", "marketing_start_date": "20210514"}], "brand_name": "Naproxen Sodium Diphenhydramine HCl", "product_id": "69842-328_46540a23-aad6-6637-e063-6394a90a569e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69842-328", "generic_name": "Naproxen Sodium Diphenhydramine HCl", "labeler_name": "CVS PHARMACY, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA213663", "marketing_category": "ANDA", "marketing_start_date": "20210514", "listing_expiration_date": "20261231"}