Home NDC 81033-103 Dextromethorphan HBr and Guaifenesin Oral Solution
Product NDC 81033-103
11-digit product format 810330103
Labeler code 81033
Product ID 81033-103_2cee75e1-ee97-6129-e063-6394a90a03dd
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr and Guaifenesin Oral Solution
Dosage form LIQUID
Route ORAL
Labeler KESIN PHARMA CORPORATION
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-02
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 100; 10 mg/5mL; mg/5mL
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dextromethorphan HBr and Guaifenesin Oral Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81033-103-05 Dextromethorphan HBr and Guaifenesin Oral Solution 5 mL in 1 CUP, UNIT-DOSE LIQUID 5 3 81033-103-10 Dextromethorphan HBr and Guaifenesin Oral Solution 10 mL in 1 CUP, UNIT-DOSE LIQUID 10 3 81033-103-50 Dextromethorphan HBr and Guaifenesin Oral Solution 100 in 1 CASE LIQUID 100 3 81033-103-51 Dextromethorphan HBr and Guaifenesin Oral Solution 100 in 1 CASE LIQUID 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81033-103 DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION LIQUID [KESIN PHARMA CORPORATION] 3 Current NDC, 4 package rows 20250131_284eae44-81bc-400c-e063-6394a90af446.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81033-103-05 81033010305 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 81033-103-10 81033010310 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 81033-103-50 81033010350 100 CUP, UNIT-DOSE in 1 CASE (81033-103-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-103-05) 2024-12-02 No No Current 81033-103-51 81033010351 100 CUP, UNIT-DOSE in 1 CASE (81033-103-51) / 10 mL in 1 CUP, UNIT-DOSE (81033-103-10) 2024-12-02 No No Current