theraflu severe cold relief nighttime

Generic: acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride

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 hydrochloride, phenylephrine hydrochloride
Labeler haleon us holdings llc
Dosage Form POWDER
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine hydrochloride 25 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-6801
Product ID 0067-6801_132cdb61-2615-2863-e063-6394a90a7e5a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-01-20

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 00676801
Hyphenated Format 0067-6801

Supplemental Identifiers

RxCUI
1659175
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 severe cold relief nighttime (source: ndc)
Generic Name acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 6 POWDER in 1 CARTON (0067-6801-02)
source: ndc

Packages (1)

0067-6801-02 6 POWDER in 1 CARTON (0067-6801-02)

Ingredients (3)

acetaminophen (500 mg/1) diphenhydramine hydrochloride (25 mg/1) phenylephrine hydrochloride (10 mg/1)

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": "132cdb61-2615-2863-e063-6394a90a7e5a", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1659175"], "spl_set_id": ["0d3b1bea-e2ca-4e07-8ae5-60627d230c96"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POWDER in 1 CARTON (0067-6801-02)", "package_ndc": "0067-6801-02", "marketing_start_date": "20220120"}], "brand_name": "Theraflu Severe Cold relief Nighttime", "product_id": "0067-6801_132cdb61-2615-2863-e063-6394a90a7e5a", "dosage_form": "POWDER", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0067-6801", "generic_name": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu Severe Cold relief Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220120", "listing_expiration_date": "20261231"}