guaifenesin, dextromethorphan hbr

Generic: guaifenesin, dextromethorphan hbr

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

Drug Facts

Product Profile

Brand Name guaifenesin, dextromethorphan hbr
Generic Name guaifenesin, dextromethorphan hbr
Labeler opmx llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/1, guaifenesin 400 mg/1

Manufacturer
OPMX LLC

Identifiers & Regulatory

Product NDC 69729-783
Product ID 69729-783_18aab413-451c-bdd4-e063-6394a90a3eb6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-02-18

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 69729783
Hyphenated Format 69729-783

Supplemental Identifiers

RxCUI
1661740
UPC
0856828008434
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 guaifenesin, dextromethorphan hbr (source: ndc)
Generic Name guaifenesin, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 400 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (69729-783-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

69729-783-02 2 BLISTER PACK in 1 CARTON (69729-783-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (20 mg/1) guaifenesin (400 mg/1)

Linked Drug Pages (1)

GUAIFENESIN, DEXTROMETHORPHAN HBR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "18aab413-451c-bdd4-e063-6394a90a3eb6", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0856828008434"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1661740"], "spl_set_id": ["9a246099-72b5-2efc-e053-2a95a90aafbc"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["OPMX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69729-783-02)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "69729-783-02", "marketing_start_date": "20190218"}], "brand_name": "GUAIFENESIN, DEXTROMETHORPHAN HBR", "product_id": "69729-783_18aab413-451c-bdd4-e063-6394a90a3eb6", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "69729-783", "generic_name": "GUAIFENESIN, DEXTROMETHORPHAN HBR", "labeler_name": "OPMX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GUAIFENESIN, DEXTROMETHORPHAN HBR", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190218", "listing_expiration_date": "20261231"}