theraflu severe cold relief nighttime

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 severe cold relief nighttime
Generic Name acetaminophen, diphenhydramine hcl, phenylephrine hcl
Labeler haleon us holdings llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/237mL, diphenhydramine hydrochloride 25 mg/237mL, phenylephrine hydrochloride 10 mg/237mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-6803
Product ID 0067-6803_10682cca-1329-1e41-e063-6394a90a7e21
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-01-20

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 00676803
Hyphenated Format 0067-6803

Supplemental Identifiers

RxCUI
1659960
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 hcl, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/237mL
  • 25 mg/237mL
  • 10 mg/237mL
source: ndc
Packaging
  • 6 PACKET in 1 CARTON (0067-6803-02) / 237 mL in 1 PACKET
source: ndc

Packages (1)

0067-6803-02 6 PACKET in 1 CARTON (0067-6803-02) / 237 mL in 1 PACKET

Ingredients (3)

acetaminophen (650 mg/237mL) diphenhydramine hydrochloride (25 mg/237mL) phenylephrine hydrochloride (10 mg/237mL)

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": "10682cca-1329-1e41-e063-6394a90a7e21", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1659960"], "spl_set_id": ["4daca846-8511-4303-9e6c-9469f7f260ba"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 PACKET in 1 CARTON (0067-6803-02)  / 237 mL in 1 PACKET", "package_ndc": "0067-6803-02", "marketing_start_date": "20230120"}], "brand_name": "Theraflu Severe Cold Relief Nighttime", "product_id": "0067-6803_10682cca-1329-1e41-e063-6394a90a7e21", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0067-6803", "generic_name": "ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE 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/237mL"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/237mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/237mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230120", "listing_expiration_date": "20261231"}