dextromethorphan hbr and guaifenesin oral solution

Generic: dextromethorphan hbr and guaifenesin oral solution

Labeler: kesin pharma corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dextromethorphan hbr and guaifenesin oral solution
Generic Name dextromethorphan hbr and guaifenesin oral solution
Labeler kesin pharma corporation
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
KESIN PHARMA CORPORATION

Identifiers & Regulatory

Product NDC 81033-103
Product ID 81033-103_2cee75e1-ee97-6129-e063-6394a90a03dd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-12-02

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 81033103
Hyphenated Format 81033-103

Supplemental Identifiers

RxCUI
996520
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 oral solution (source: ndc)
Generic Name dextromethorphan hbr and guaifenesin oral solution (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 CASE (81033-103-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-103-05)
  • 100 CUP, UNIT-DOSE in 1 CASE (81033-103-51) / 10 mL in 1 CUP, UNIT-DOSE (81033-103-10)
source: ndc

Packages (2)

81033-103-50 100 CUP, UNIT-DOSE in 1 CASE (81033-103-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-103-05) 81033-103-51 100 CUP, UNIT-DOSE in 1 CASE (81033-103-51) / 10 mL in 1 CUP, UNIT-DOSE (81033-103-10)

Ingredients (2)

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

Linked Drug Pages (1)

Dextromethorphan HBr and Guaifenesin Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2cee75e1-ee97-6129-e063-6394a90a03dd", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["284eae44-81bc-400c-e063-6394a90af446"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["KESIN PHARMA CORPORATION"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CUP, UNIT-DOSE in 1 CASE (81033-103-50)  / 5 mL in 1 CUP, UNIT-DOSE (81033-103-05)", "package_ndc": "81033-103-50", "marketing_start_date": "20241202"}, {"sample": false, "description": "100 CUP, UNIT-DOSE in 1 CASE (81033-103-51)  / 10 mL in 1 CUP, UNIT-DOSE (81033-103-10)", "package_ndc": "81033-103-51", "marketing_start_date": "20241202"}], "brand_name": "Dextromethorphan HBr and Guaifenesin Oral Solution", "product_id": "81033-103_2cee75e1-ee97-6129-e063-6394a90a03dd", "dosage_form": "LIQUID", "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": "81033-103", "generic_name": "Dextromethorphan HBr and Guaifenesin Oral Solution", "labeler_name": "KESIN PHARMA CORPORATION", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dextromethorphan HBr and Guaifenesin Oral Solution", "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": "20241202", "listing_expiration_date": "20261231"}