theraflu severe cold relief nighttime

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
Generic Name acetaminophen, diphenhydramine hcl
Labeler haleon us holdings llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, diphenhydramine hydrochloride 25 mg/30mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-0105
Product ID 0067-0105_438014e3-6d78-1332-e063-6394a90afc47
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

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 00670105
Hyphenated Format 0067-0105

Supplemental Identifiers

RxCUI
1294607
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 (source: ndc)
Generic Name acetaminophen, diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 25 mg/30mL
source: ndc
Packaging
  • 245.5 mL in 1 BOTTLE (0067-0105-08)
source: ndc

Packages (1)

0067-0105-08 245.5 mL in 1 BOTTLE (0067-0105-08)

Ingredients (2)

acetaminophen (650 mg/30mL) diphenhydramine hydrochloride (25 mg/30mL)

Linked Drug Pages (1)

Theraflu Severe Cold Relief Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "438014e3-6d78-1332-e063-6394a90afc47", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1294607"], "spl_set_id": ["c24b9489-208c-472b-8ae5-c6e86c12e04d"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "245.5 mL in 1 BOTTLE (0067-0105-08)", "package_ndc": "0067-0105-08", "marketing_start_date": "20231201"}], "brand_name": "Theraflu Severe Cold Relief Nighttime", "product_id": "0067-0105_438014e3-6d78-1332-e063-6394a90afc47", "dosage_form": "SYRUP", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0067-0105", "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", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}