theraflu severe cold relief nighttime soft chews

Generic: acetaminophen, diphenhydramine hcl

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

Drug Facts

Product Profile

Brand Name theraflu severe cold relief nighttime soft chews
Generic Name acetaminophen, diphenhydramine hcl
Labeler haleon us holdings llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

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

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-0112
Product ID 0067-0112_21636332-818b-26bf-e063-6394a90a1925
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-09-30

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 00670112
Hyphenated Format 0067-0112

Supplemental Identifiers

RxCUI
2691689
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 theraflu severe cold relief nighttime soft chews (source: ndc)
Generic Name acetaminophen, diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 12.5 mg/1
source: ndc
Packaging
  • 20 TABLET, CHEWABLE in 1 BOTTLE (0067-0112-01)
source: ndc

Packages (1)

0067-0112-01 20 TABLET, CHEWABLE in 1 BOTTLE (0067-0112-01)

Ingredients (2)

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

Linked Drug Pages (1)

Theraflu Severe Cold Relief Nighttime Soft Chews ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21636332-818b-26bf-e063-6394a90a1925", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["2691689"], "spl_set_id": ["6ba64bbe-7599-406a-9187-737c0f8c1c2a"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, CHEWABLE in 1 BOTTLE (0067-0112-01)", "package_ndc": "0067-0112-01", "marketing_start_date": "20240930"}], "brand_name": "Theraflu Severe Cold Relief Nighttime Soft Chews", "product_id": "0067-0112_21636332-818b-26bf-e063-6394a90a1925", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0067-0112", "generic_name": "Acetaminophen, Diphenhydramine HCl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu", "brand_name_suffix": "Severe Cold Relief Nighttime Soft Chews", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240930", "listing_expiration_date": "20261231"}