Home NDC 35916-0760 Dextromethorphan Hbr,Guaifenesin
Product NDC 35916-0760
11-digit product format 359160760
Labeler code 35916
Product ID 35916-0760_47b53021-eb30-c736-e063-6294a90ae369
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hbr,Guaifenesin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler SOFTGEL HEALTHCARE PRIVATE LIMITED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-21
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 200; 10 mg/1; mg/1
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 2027-12-31
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,Guaifenesin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
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 1111663 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 35916-0760-1 Dextromethorphan Hbr,Guaifenesin 1000 in 1 BAG CAPSULE, LIQUID FILLED 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35916-0760 DEXTROMETHORPHAN HBR,GUAIFENESIN CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD] 1 Current NDC, 1 package rows 20250327_2fbbfc7c-81a9-b647-e063-6394a90a55ac.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 Marketing start Sample Exclude flag Status 35916-0760-1 35916076001 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0760-1) 2025-03-21 No No Current