childrens robitussin cough and cold cf

Generic: dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens robitussin cough and cold cf
Generic Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler haleon us holdings llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 50 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8716
Product ID 0031-8716_13de3a9e-573f-846a-e063-6294a90a53c9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M001
Listing Expiration 2026-12-31
Marketing Start 2009-09-01

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 00318716
Hyphenated Format 0031-8716

Supplemental Identifiers

RxCUI
1370205
UNII
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 childrens robitussin cough and cold cf (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 50 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0031-8716-12) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

0031-8716-12 1 BOTTLE in 1 CARTON (0031-8716-12) / 118 mL in 1 BOTTLE

Ingredients (3)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (50 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Childrens Robitussin Cough and Cold CF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "13de3a9e-573f-846a-e063-6294a90a53c9", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1370205"], "spl_set_id": ["fcd0a8e0-ac2a-039a-be3c-534195d6bcfd"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8716-12)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-8716-12", "marketing_start_date": "20090901"}], "brand_name": "Childrens Robitussin Cough and Cold CF", "product_id": "0031-8716_13de3a9e-573f-846a-e063-6294a90a53c9", "dosage_form": "LIQUID", "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": "0031-8716", "generic_name": "dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Robitussin Cough and Cold CF", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "50 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M001", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20090901", "listing_expiration_date": "20261231"}