theraflu expressmax nighttime severe cold and cough

Generic: acetaminophen, diphenhydramine hcl, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name theraflu expressmax nighttime severe cold and cough
Generic Name acetaminophen, diphenhydramine hcl, phenylephrine hcl
Labeler haleon us holdings llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, diphenhydramine hydrochloride 12.5 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-8137
Product ID 0067-8137_13185fea-1e12-cf5a-e063-6394a90a18af
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2016-07-05

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00678137
Hyphenated Format 0067-8137

Supplemental Identifiers

RxCUI
1233575
UNII
362O9ITL9D TC2D6JAD40 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 theraflu expressmax nighttime severe cold and cough (source: ndc)
Generic Name acetaminophen, diphenhydramine hcl, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 12.5 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0067-8137-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (0067-8137-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0067-8137-10 1 BLISTER PACK in 1 CARTON (0067-8137-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 0067-8137-20 2 BLISTER PACK in 1 CARTON (0067-8137-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) diphenhydramine hydrochloride (12.5 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Theraflu ExpressMax Nighttime Severe Cold and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "13185fea-1e12-cf5a-e063-6394a90a18af", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1233575"], "spl_set_id": ["62f7fcb9-e31a-4634-b1c2-44a9567e3a61"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0067-8137-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0067-8137-10", "marketing_start_date": "20170608"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0067-8137-20)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0067-8137-20", "marketing_start_date": "20160705"}], "brand_name": "Theraflu ExpressMax Nighttime Severe Cold and Cough", "product_id": "0067-8137_13185fea-1e12-cf5a-e063-6394a90a18af", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0067-8137", "generic_name": "acetaminophen, diphenhydramine HCl, phenylephrine HCl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu ExpressMax", "brand_name_suffix": "Nighttime Severe Cold and Cough", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160705", "listing_expiration_date": "20261231"}