dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Generic: dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Generic Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler westminster pharmaceuticals, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 18 mg/15mL, guaifenesin 200 mg/15mL, phenylephrine hydrochloride 10 mg/15mL

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-184
Product ID 69367-184_4bb61a68-58fa-45ed-b9e8-4a5f83f7046b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-03-15

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 69367184
Hyphenated Format 69367-184

Supplemental Identifiers

RxCUI
1429362
UPC
0369367184083
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 dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 18 mg/15mL
  • 200 mg/15mL
  • 10 mg/15mL
source: ndc
Packaging
  • 240 mL in 1 BOTTLE (69367-184-08)
source: ndc

Packages (1)

Ingredients (3)

dextromethorphan hydrobromide (18 mg/15mL) guaifenesin (200 mg/15mL) phenylephrine hydrochloride (10 mg/15mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4bb61a68-58fa-45ed-b9e8-4a5f83f7046b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0369367184083"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1429362"], "spl_set_id": ["a58bfb14-28f9-4425-a5a5-aaff4847c979"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 mL in 1 BOTTLE (69367-184-08)", "package_ndc": "69367-184-08", "marketing_start_date": "20180315"}], "brand_name": "DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE", "product_id": "69367-184_4bb61a68-58fa-45ed-b9e8-4a5f83f7046b", "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": "69367-184", "generic_name": "DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "18 mg/15mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180315", "listing_expiration_date": "20261231"}