vanacof dm

Generic: dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Labeler: gm pharmaceuticals, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name vanacof dm
Generic Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler gm pharmaceuticals, inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
GM Pharmaceuticals, INC

Identifiers & Regulatory

Product NDC 58809-555
Product ID 58809-555_42b78046-7cf6-3ab7-e063-6394a90a67a6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2013-06-01

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 58809555
Hyphenated Format 58809-555

Supplemental Identifiers

RxCUI
1429362
UPC
0358809555086
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 vanacof dm (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 (58809-555-08)
source: ndc

Packages (1)

58809-555-08 240 mL in 1 BOTTLE (58809-555-08)

Ingredients (3)

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

Linked Drug Pages (1)

VANACOF DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42b78046-7cf6-3ab7-e063-6394a90a67a6", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0358809555086"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1429362"], "spl_set_id": ["2ed699f2-d004-4fa9-8042-6c85a9ff69b6"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["GM Pharmaceuticals, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 mL in 1 BOTTLE (58809-555-08)", "package_ndc": "58809-555-08", "marketing_start_date": "20130601"}], "brand_name": "VANACOF DM", "product_id": "58809-555_42b78046-7cf6-3ab7-e063-6394a90a67a6", "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": "58809-555", "generic_name": "DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "GM Pharmaceuticals, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "VANACOF DM", "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": "20130601", "listing_expiration_date": "20261231"}