good sense naproxen sodium

Generic: diphenhydramine hydrochloride, naproxen sodium

Labeler: l. perrigo company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name good sense naproxen sodium
Generic Name diphenhydramine hydrochloride, naproxen sodium
Labeler l. perrigo company
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
L. Perrigo Company

Identifiers & Regulatory

Product NDC 0113-8264
Product ID 0113-8264_b3bcb8c1-c51c-4a01-95df-e1b2fb041eee
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208499
Listing Expiration 2026-12-31
Marketing Start 2018-12-28

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 01138264
Hyphenated Format 0113-8264

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 good sense naproxen sodium (source: ndc)
Generic Name diphenhydramine hydrochloride, naproxen sodium (source: ndc)
Application Number ANDA208499 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0113-8264-60) / 20 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0113-8264-71) / 50 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

0113-8264-60 1 BOTTLE in 1 CARTON (0113-8264-60) / 20 TABLET, FILM COATED in 1 BOTTLE 0113-8264-71 1 BOTTLE in 1 CARTON (0113-8264-71) / 50 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

good sense naproxen sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b3bcb8c1-c51c-4a01-95df-e1b2fb041eee", "openfda": {"unii": ["TC2D6JAD40", "9TN87S3A3C"], "rxcui": ["1550957"], "spl_set_id": ["f548aa3d-b35e-458a-9815-3595a451ab78"], "manufacturer_name": ["L. Perrigo Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0113-8264-60)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0113-8264-60", "marketing_start_date": "20181228"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0113-8264-71)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0113-8264-71", "marketing_start_date": "20220314"}], "brand_name": "good sense naproxen sodium", "product_id": "0113-8264_b3bcb8c1-c51c-4a01-95df-e1b2fb041eee", "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": "0113-8264", "generic_name": "diphenhydramine hydrochloride, naproxen sodium", "labeler_name": "L. Perrigo Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "good sense naproxen sodium", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA208499", "marketing_category": "ANDA", "marketing_start_date": "20181228", "listing_expiration_date": "20261231"}