cold head congestion severe (37808-775)

Drug Facts

Product Profile

Brand Name cold head congestion severe

Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride

Labeler heb

Dosage Form TABLET, COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

HEB

Identifiers & Regulatory

Product NDC 37808-775

Product ID 37808-775_2501bd52-2de5-3c3f-e063-6394a90acf49

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2018-04-01

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 37808775

Hyphenated Format 37808-775

Supplemental Identifiers

RxCUI

1243679

UPC

0041220385874

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 head congestion severe (source: ndc)

Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride (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 (37808-775-02) / 12 TABLET, COATED in 1 BLISTER PACK

source: ndc

Packages (1)

37808-775-02 2 BLISTER PACK in 1 CARTON (37808-775-02) / 12 TABLET, 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 Head Congestion Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2501bd52-2de5-3c3f-e063-6394a90acf49", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0041220385874"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["c3849b66-697f-4f6e-93ab-76de031b3c70"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["HEB"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (37808-775-02)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "37808-775-02", "marketing_start_date": "20180401"}], "brand_name": "Cold Head Congestion Severe", "product_id": "37808-775_2501bd52-2de5-3c3f-e063-6394a90acf49", "dosage_form": "TABLET, 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": "37808-775", "generic_name": "ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "HEB", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold 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": "20180401", "listing_expiration_date": "20261231"}