panadol pm

Generic: acetaminophen and diphenhydramine hcl

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name panadol pm
Generic Name acetaminophen and diphenhydramine hcl
Labeler haleon us holdings llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine hydrochloride 25 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-7021
Product ID 0135-7021_10c195cf-3021-2052-e063-6294a90a1ea0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2021-06-25

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01357021
Hyphenated Format 0135-7021

Supplemental Identifiers

RxCUI
1092189 1094718
UNII
362O9ITL9D TC2D6JAD40

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 panadol pm (source: ndc)
Generic Name acetaminophen and diphenhydramine hcl (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (0135-7021-01) / 2 TABLET, FILM COATED in 1 PACKET
  • 1 BOTTLE in 1 CARTON (0135-7021-02) / 24 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0135-7021-03) / 50 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

0135-7021-01 50 PACKET in 1 CARTON (0135-7021-01) / 2 TABLET, FILM COATED in 1 PACKET 0135-7021-02 1 BOTTLE in 1 CARTON (0135-7021-02) / 24 TABLET, FILM COATED in 1 BOTTLE 0135-7021-03 1 BOTTLE in 1 CARTON (0135-7021-03) / 50 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

acetaminophen (500 mg/1) diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

PANADOL PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "10c195cf-3021-2052-e063-6294a90a1ea0", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189", "1094718"], "spl_set_id": ["fe7cd1f2-9b00-4ded-99c2-8a152c71093c"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (0135-7021-01)  / 2 TABLET, FILM COATED in 1 PACKET", "package_ndc": "0135-7021-01", "marketing_start_date": "20220519"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0135-7021-02)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0135-7021-02", "marketing_start_date": "20211207"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0135-7021-03)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0135-7021-03", "marketing_start_date": "20211207"}], "brand_name": "PANADOL PM", "product_id": "0135-7021_10c195cf-3021-2052-e063-6294a90a1ea0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0135-7021", "generic_name": "acetaminophen and diphenhydramine HCl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PANADOL", "brand_name_suffix": "PM", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210625", "listing_expiration_date": "20261231"}