naproxen sodium and diphenhydramine hcl

Generic: naproxen sodium and diphenhydramine

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium and diphenhydramine hcl
Generic Name naproxen sodium and diphenhydramine
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1422
Product ID 69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209726
Listing Expiration 2026-12-31
Marketing Start 2018-10-23

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 692381422
Hyphenated Format 69238-1422

Supplemental Identifiers

RxCUI
1550957
UPC
0369238142266
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 and diphenhydramine hcl (source: ndc)
Generic Name naproxen sodium and diphenhydramine (source: ndc)
Application Number ANDA209726 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69238-1422-8) / 80 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (4)

69238-1422-2 1 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLE 69238-1422-4 1 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLE 69238-1422-6 1 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLE 69238-1422-8 1 BOTTLE in 1 CARTON (69238-1422-8) / 80 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Naproxen Sodium and Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b9db3e35-7654-4bf3-8536-38f56b8780c7", "openfda": {"upc": ["0369238142266"], "unii": ["TC2D6JAD40", "9TN87S3A3C"], "rxcui": ["1550957"], "spl_set_id": ["caca14cf-95f2-4c60-8bba-2154b8f353a3"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69238-1422-2)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69238-1422-2", "marketing_start_date": "20181023"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69238-1422-4)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69238-1422-4", "marketing_start_date": "20181023"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69238-1422-6)  / 160 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69238-1422-6", "marketing_start_date": "20181023"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69238-1422-8)  / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69238-1422-8", "marketing_start_date": "20181023"}], "brand_name": "Naproxen Sodium and Diphenhydramine HCl", "product_id": "69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7", "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": "69238-1422", "generic_name": "Naproxen Sodium and Diphenhydramine", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium and Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA209726", "marketing_category": "ANDA", "marketing_start_date": "20181023", "listing_expiration_date": "20261231"}