naproxen sodium diphenhydramine hydrochloride

Generic: naproxen sodium diphenhydramine hydrochloride

Labeler: safeway
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium diphenhydramine hydrochloride
Generic Name naproxen sodium diphenhydramine hydrochloride
Labeler safeway
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
SAFEWAY

Identifiers & Regulatory

Product NDC 21130-814
Product ID 21130-814_463f13c5-0aeb-3fa5-e063-6394a90afe8c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213663
Listing Expiration 2026-12-31
Marketing Start 2023-06-30

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 21130814
Hyphenated Format 21130-814

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 hydrochloride (source: ndc)
Generic Name naproxen sodium diphenhydramine hydrochloride (source: ndc)
Application Number ANDA213663 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 220 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (21130-814-05)
source: ndc

Packages (1)

21130-814-05 50 TABLET in 1 BOTTLE (21130-814-05)

Ingredients (2)

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

Linked Drug Pages (1)

Naproxen Sodium Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "463f13c5-0aeb-3fa5-e063-6394a90afe8c", "openfda": {"unii": ["TC2D6JAD40", "9TN87S3A3C"], "rxcui": ["1550957"], "spl_set_id": ["ed0f3275-f156-13a3-e053-2a95a90a2ce8"], "manufacturer_name": ["SAFEWAY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (21130-814-05)", "package_ndc": "21130-814-05", "marketing_start_date": "20230630"}], "brand_name": "Naproxen Sodium Diphenhydramine Hydrochloride", "product_id": "21130-814_463f13c5-0aeb-3fa5-e063-6394a90afe8c", "dosage_form": "TABLET", "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": "21130-814", "generic_name": "Naproxen Sodium Diphenhydramine Hydrochloride", "labeler_name": "SAFEWAY", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium Diphenhydramine Hydrochloride", "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": "20230630", "listing_expiration_date": "20261231"}