careone naproxen sodium pm

Generic: diphenhydramine hydrochloride, naproxen sodium

Labeler: american sales company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name careone naproxen sodium pm
Generic Name diphenhydramine hydrochloride, naproxen sodium
Labeler american sales company
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
American Sales Company

Identifiers & Regulatory

Product NDC 41520-264
Product ID 41520-264_65baf60d-f7f4-4482-a7a4-3aab220925e2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208499
Listing Expiration 2026-12-31
Marketing Start 2020-02-25

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 41520264
Hyphenated Format 41520-264

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 careone naproxen sodium pm (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 (41520-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (41520-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

41520-264-27 1 BOTTLE in 1 CARTON (41520-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE 41520-264-60 1 BOTTLE in 1 CARTON (41520-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

careone naproxen sodium pm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "65baf60d-f7f4-4482-a7a4-3aab220925e2", "openfda": {"unii": ["TC2D6JAD40", "9TN87S3A3C"], "rxcui": ["1550957"], "spl_set_id": ["16547905-59c0-4936-82e1-2d9f5935d8dd"], "manufacturer_name": ["American Sales Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (41520-264-27)  / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "41520-264-27", "marketing_start_date": "20200225"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (41520-264-60)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "41520-264-60", "marketing_start_date": "20200225"}], "brand_name": "careone naproxen sodium pm", "product_id": "41520-264_65baf60d-f7f4-4482-a7a4-3aab220925e2", "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": "41520-264", "generic_name": "diphenhydramine hydrochloride, naproxen sodium", "labeler_name": "American Sales Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "careone naproxen sodium pm", "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": "20200225", "listing_expiration_date": "20261231"}