mucinex childrens cold and flu

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name mucinex childrens cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler rb health (us) llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/10mL, dextromethorphan hydrobromide 10 mg/10mL, guaifenesin 200 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-954
Product ID 63824-954_29a659fd-d4d2-2521-e063-6294a90a59f4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-04-01

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 63824954
Hyphenated Format 63824-954

Supplemental Identifiers

RxCUI
1116572
UPC
0363824278643
UNII
362O9ITL9D 9D2RTI9KYH 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 mucinex childrens cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/10mL
  • 10 mg/10mL
  • 200 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63824-954-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

63824-954-04 1 BOTTLE in 1 CARTON (63824-954-04) / 118 mL in 1 BOTTLE

Ingredients (4)

acetaminophen (325 mg/10mL) dextromethorphan hydrobromide (10 mg/10mL) guaifenesin (200 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

Mucinex Childrens Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "29a659fd-d4d2-2521-e063-6294a90a59f4", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0363824278643"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116572"], "spl_set_id": ["5bda415d-739f-4ca5-b5b2-07c14a81863b"], "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": "1 BOTTLE in 1 CARTON (63824-954-04)  / 118 mL in 1 BOTTLE", "package_ndc": "63824-954-04", "marketing_start_date": "20190401"}], "brand_name": "Mucinex Childrens Cold and Flu", "product_id": "63824-954_29a659fd-d4d2-2521-e063-6294a90a59f4", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "63824-954", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucinex Childrens", "brand_name_suffix": "Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190401", "listing_expiration_date": "20261231"}