Home NDC 35916-0184 Acetaminophen, Dextromethorphan HBr ,Guaifenesin
Product NDC 35916-0184
11-digit product format 359160184
Labeler code 35916
Product ID 35916-0184_50039825-a8a4-cd65-e063-6294a90a5fd6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr ,Guaifenesin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Softgel Healthcare Pvt Ltd
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-17
Substance GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 200; 325; 10 mg/1; 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 Acetaminophen, Dextromethorphan HBr ,Guaifenesin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/1 ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 362O9ITL9D 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 2377385 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 35916-0184-2 Acetaminophen, Dextromethorphan HBr ,Guaifenesin 3000 in 1 POUCH CAPSULE, LIQUID FILLED 3000 5 35916-0184-3 Acetaminophen, Dextromethorphan HBr ,Guaifenesin 2000 in 1 POUCH CAPSULE, LIQUID FILLED 2000 5 35916-0184-3 Acetaminophen, Dextromethorphan HBr ,Guaifenesin 2 in 1 BOX CAPSULE, LIQUID FILLED 2 5 35916-0184-4 Acetaminophen, Dextromethorphan HBr ,Guaifenesin 1500 in 1 BAG CAPSULE, LIQUID FILLED 1500 5 35916-0184-4 Acetaminophen, Dextromethorphan HBr ,Guaifenesin 2 in 1 BOX CAPSULE, LIQUID FILLED 2 5
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 98 of 178 · 3,551 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 35916-0184-2 35916018402 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0184-2) 2025-05-17 No No Current 35916-0184-3 35916018403 2 POUCH in 1 BOX (35916-0184-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH 2 pouch 2025-09-25 No No Current 35916-0184-4 35916018404 2 BAG in 1 BOX (35916-0184-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG 2 bag 2026-01-16 No No Current