panadol cold and flu nondrowsy

Generic: acetaminophen and phenyleprine hcl

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

Drug Facts

Product Profile

Brand Name panadol cold and flu nondrowsy
Generic Name acetaminophen and phenyleprine hcl
Labeler haleon us holdings llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0607
Product ID 0135-0607_10c08cd4-8a3b-c9ad-e063-6394a90a9641
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2017-06-01

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350607
Hyphenated Format 0135-0607

Supplemental Identifiers

RxCUI
1046378
UNII
362O9ITL9D 04JA59TNSJ

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 cold and flu nondrowsy (source: ndc)
Generic Name acetaminophen and phenyleprine hcl (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0135-0607-02) / 8 TABLET, FILM COATED in 1 BLISTER PACK
  • 50 PACKET in 1 CARTON (0135-0607-03) / 2 TABLET, FILM COATED in 1 PACKET (0135-0607-01)
source: ndc

Packages (2)

0135-0607-02 3 BLISTER PACK in 1 CARTON (0135-0607-02) / 8 TABLET, FILM COATED in 1 BLISTER PACK 0135-0607-03 50 PACKET in 1 CARTON (0135-0607-03) / 2 TABLET, FILM COATED in 1 PACKET (0135-0607-01)

Ingredients (2)

acetaminophen (325 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Panadol Cold and Flu NonDrowsy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "10c08cd4-8a3b-c9ad-e063-6394a90a9641", "openfda": {"unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1046378"], "spl_set_id": ["f626ab17-01c9-4493-ba9e-0c8c11146384"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0135-0607-02)  / 8 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0135-0607-02", "marketing_start_date": "20170601"}, {"sample": false, "description": "50 PACKET in 1 CARTON (0135-0607-03)  / 2 TABLET, FILM COATED in 1 PACKET (0135-0607-01)", "package_ndc": "0135-0607-03", "marketing_start_date": "20170601"}], "brand_name": "Panadol Cold and Flu NonDrowsy", "product_id": "0135-0607_10c08cd4-8a3b-c9ad-e063-6394a90a9641", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0135-0607", "generic_name": "acetaminophen and phenyleprine HCl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Panadol", "brand_name_suffix": "Cold and Flu NonDrowsy", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170601", "listing_expiration_date": "20261231"}