cold and head congestion severe

Generic: acetaminophen, guaifenesin, phenylephrine hcl

Labeler: meijer distribution, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold and head congestion severe
Generic Name acetaminophen, guaifenesin, phenylephrine hcl
Labeler meijer distribution, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Meijer Distribution, Inc.

Identifiers & Regulatory

Product NDC 79481-3572
Product ID 79481-3572_2a410557-4aea-49b3-83c7-fae2b27162ef
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-09-10

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 794813572
Hyphenated Format 79481-3572

Supplemental Identifiers

RxCUI
1243679
UPC
0713733972567
UNII
362O9ITL9D 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 cold and head congestion severe (source: ndc)
Generic Name acetaminophen, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (79481-3572-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

79481-3572-8 2 BLISTER PACK in 1 CARTON (79481-3572-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Cold and Head Congestion Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a410557-4aea-49b3-83c7-fae2b27162ef", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0713733972567"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["a41c62aa-90a4-4958-984f-b2fed0276c8a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Meijer Distribution, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (79481-3572-8)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "79481-3572-8", "marketing_start_date": "20240910"}], "brand_name": "Cold and Head Congestion Severe", "product_id": "79481-3572_2a410557-4aea-49b3-83c7-fae2b27162ef", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "79481-3572", "generic_name": "Acetaminophen, Guaifenesin, Phenylephrine HCl", "labeler_name": "Meijer Distribution, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold and Head Congestion Severe", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240910", "listing_expiration_date": "20261231"}