robitussin peak cold multi-symptom cold

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 robitussin peak cold multi-symptom cold
Generic Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler haleon us holdings llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 100 mg/5mL, phenylephrine hydrochloride 5 mg/5mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8742
Product ID 0031-8742_156f961c-feec-9b90-e063-6394a90a7b0b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2011-06-12

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 00318742
Hyphenated Format 0031-8742

Supplemental Identifiers

RxCUI
1044949
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 robitussin peak cold multi-symptom cold (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0031-8742-14) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0031-8742-20) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

0031-8742-14 1 BOTTLE in 1 CARTON (0031-8742-14) / 118 mL in 1 BOTTLE 0031-8742-20 1 BOTTLE in 1 CARTON (0031-8742-20) / 237 mL in 1 BOTTLE

Ingredients (3)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (100 mg/5mL) phenylephrine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Robitussin Peak Cold Multi-Symptom Cold ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "156f961c-feec-9b90-e063-6394a90a7b0b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1044949"], "spl_set_id": ["8c0a2424-e8ac-d91c-b46d-a5ee29f91936"], "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 (0031-8742-14)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-8742-14", "marketing_start_date": "20110612"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8742-20)  / 237 mL in 1 BOTTLE", "package_ndc": "0031-8742-20", "marketing_start_date": "20110612"}], "brand_name": "Robitussin Peak Cold Multi-Symptom Cold", "product_id": "0031-8742_156f961c-feec-9b90-e063-6394a90a7b0b", "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": "0031-8742", "generic_name": "dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Peak Cold Multi-Symptom Cold", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20110612", "listing_expiration_date": "20261231"}