aleve pm

Generic: diphenhydramine hydrochloride and naproxen sodium

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aleve pm
Generic Name diphenhydramine hydrochloride and naproxen sodium
Labeler bayer healthcare llc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-1200
Product ID 0280-1200_45265ccc-d985-a6ad-e063-6394a90a75b7
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA205352
Listing Expiration 2026-12-31
Marketing Start 2014-09-09

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 02801200
Hyphenated Format 0280-1200

Supplemental Identifiers

RxCUI
1550957 1550963
UPC
0025866591882
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 aleve pm (source: ndc)
Generic Name diphenhydramine hydrochloride and naproxen sodium (source: ndc)
Application Number NDA205352 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0280-1200-01) / 120 TABLET, FILM COATED in 1 BOTTLE
  • 2 TABLET, FILM COATED in 1 POUCH (0280-1200-02)
  • 160 TABLET, FILM COATED in 1 BOTTLE (0280-1200-03)
  • 1 BOTTLE in 1 CARTON (0280-1200-04) / 40 TABLET, FILM COATED in 1 BOTTLE
  • 80 TABLET, FILM COATED in 1 BOTTLE (0280-1200-05)
  • 1 BOTTLE in 1 CARTON (0280-1200-08) / 250 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0280-1200-20) / 20 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0280-1200-40) / 40 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0280-1200-80) / 80 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (9)

0280-1200-01 1 BOTTLE in 1 CARTON (0280-1200-01) / 120 TABLET, FILM COATED in 1 BOTTLE 0280-1200-02 2 TABLET, FILM COATED in 1 POUCH (0280-1200-02) 0280-1200-03 160 TABLET, FILM COATED in 1 BOTTLE (0280-1200-03) 0280-1200-04 1 BOTTLE in 1 CARTON (0280-1200-04) / 40 TABLET, FILM COATED in 1 BOTTLE 0280-1200-05 80 TABLET, FILM COATED in 1 BOTTLE (0280-1200-05) 0280-1200-08 1 BOTTLE in 1 CARTON (0280-1200-08) / 250 TABLET, FILM COATED in 1 BOTTLE 0280-1200-20 1 BOTTLE in 1 CARTON (0280-1200-20) / 20 TABLET, FILM COATED in 1 BOTTLE 0280-1200-40 1 BOTTLE in 1 CARTON (0280-1200-40) / 40 TABLET, FILM COATED in 1 BOTTLE 0280-1200-80 1 BOTTLE in 1 CARTON (0280-1200-80) / 80 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Aleve PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45265ccc-d985-a6ad-e063-6394a90a75b7", "openfda": {"upc": ["0025866591882"], "unii": ["TC2D6JAD40", "9TN87S3A3C"], "rxcui": ["1550957", "1550963"], "spl_set_id": ["82891458-ab0d-459a-8602-dcebd22c3010"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-1200-01)  / 120 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0280-1200-01", "marketing_start_date": "20140909"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 POUCH (0280-1200-02)", "package_ndc": "0280-1200-02", "marketing_start_date": "20140909"}, {"sample": false, "description": "160 TABLET, FILM COATED in 1 BOTTLE (0280-1200-03)", "package_ndc": "0280-1200-03", "marketing_start_date": "20140909"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-1200-04)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0280-1200-04", "marketing_start_date": "20140909"}, {"sample": false, "description": "80 TABLET, FILM COATED in 1 BOTTLE (0280-1200-05)", "package_ndc": "0280-1200-05", "marketing_start_date": "20140909"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-1200-08)  / 250 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0280-1200-08", "marketing_start_date": "20210701"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-1200-20)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0280-1200-20", "marketing_start_date": "20140909"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-1200-40)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0280-1200-40", "marketing_start_date": "20140909"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-1200-80)  / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0280-1200-80", "marketing_start_date": "20140909"}], "brand_name": "Aleve PM", "product_id": "0280-1200_45265ccc-d985-a6ad-e063-6394a90a75b7", "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": "0280-1200", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Aleve PM", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "NDA205352", "marketing_category": "NDA", "marketing_start_date": "20140909", "listing_expiration_date": "20261231"}