mucinex cold, flu, and sore throat

Generic: acetaminophen, guaifenesin

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name mucinex cold, flu, and sore throat
Generic Name acetaminophen, guaifenesin
Labeler rb health (us) llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, guaifenesin 200 mg/1

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 72854-164
Product ID 72854-164_37decf3c-497c-fe81-e063-6394a90a5c2d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

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 72854164
Hyphenated Format 72854-164

Supplemental Identifiers

RxCUI
707195
UNII
362O9ITL9D 495W7451VQ
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 mucinex cold, flu, and sore throat (source: ndc)
Generic Name acetaminophen, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (72854-164-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

72854-164-16 2 BLISTER PACK in 1 CARTON (72854-164-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (2)

acetaminophen (325 mg/1) guaifenesin (200 mg/1)

Linked Drug Pages (1)

Mucinex Cold, Flu, and Sore Throat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37decf3c-497c-fe81-e063-6394a90a5c2d", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ"], "rxcui": ["707195"], "spl_set_id": ["37ded76a-ee8d-f22c-e063-6394a90a00c2"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (72854-164-16)  / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "72854-164-16", "marketing_start_date": "20250601"}], "brand_name": "Mucinex Cold, Flu, and Sore Throat", "product_id": "72854-164_37decf3c-497c-fe81-e063-6394a90a5c2d", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "72854-164", "generic_name": "Acetaminophen, Guaifenesin", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucinex Cold, Flu, and Sore Throat", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}