cold and head congestion severe

Generic: acetaminophen, guaifenesin, and phenylephrine hydrochloride

Labeler: topco associates llc
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, and phenylephrine hydrochloride
Labeler topco associates llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
TopCo Associates LLC

Identifiers & Regulatory

Product NDC 36800-575
Product ID 36800-575_28601152-e9f5-4e29-e063-6294a90a083c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-06-30

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 36800575
Hyphenated Format 36800-575

Supplemental Identifiers

RxCUI
1243679
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, 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 (36800-575-02) / 12 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

36800-575-02 2 BLISTER PACK in 1 CARTON (36800-575-02) / 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 and Head Congestion Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "28601152-e9f5-4e29-e063-6294a90a083c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["e07d880b-a12a-4e5e-94c0-bd36bcfe738c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["TopCo Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (36800-575-02)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "36800-575-02", "marketing_start_date": "20170630"}], "brand_name": "Cold and Head Congestion Severe", "product_id": "36800-575_28601152-e9f5-4e29-e063-6294a90a083c", "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": "36800-575", "generic_name": "ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "TopCo Associates LLC", "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": "20170630", "listing_expiration_date": "20261231"}