dextromethorphan hbr. and guaifenesin

Generic: dextromethorphan hbr. and guaifenesin

Labeler: everpharm llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dextromethorphan hbr. and guaifenesin
Generic Name dextromethorphan hbr. and guaifenesin
Labeler everpharm llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Everpharm LLC

Identifiers & Regulatory

Product NDC 84415-014
Product ID 84415-014_2bda25ff-9e45-8f8d-e063-6294a90a6a0f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-01-16

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 84415014
Hyphenated Format 84415-014

Supplemental Identifiers

RxCUI
996520
UNII
9D2RTI9KYH 495W7451VQ
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 hbr. and guaifenesin (source: ndc)
Generic Name dextromethorphan hbr. and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-014-01) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

84415-014-01 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-014-01) / 5 mL in 1 CUP, UNIT-DOSE

Ingredients (2)

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

Linked Drug Pages (1)

Dextromethorphan HBr. and Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2bda25ff-9e45-8f8d-e063-6294a90a6a0f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["0c7cd5c4-459d-4e42-ae22-b94f2e29cffb"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Everpharm LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-014-01)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "84415-014-01", "marketing_start_date": "20250116"}], "brand_name": "Dextromethorphan HBr. and Guaifenesin", "product_id": "84415-014_2bda25ff-9e45-8f8d-e063-6294a90a6a0f", "dosage_form": "SOLUTION", "pharm_class": ["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]"], "product_ndc": "84415-014", "generic_name": "Dextromethorphan HBr. and Guaifenesin", "labeler_name": "Everpharm LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dextromethorphan HBr. and Guaifenesin", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250116", "listing_expiration_date": "20261231"}