Home NDC 35916-0461 Dextromethorphan Hydrobromide
Product NDC 35916-0461
11-digit product format 359160461
Labeler code 35916
Product ID 35916-0461_5d533645-2151-6cae-e063-6394a90aaeaf
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Softgel Healthcare Pvt Ltd
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-11
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 mg/1
Pharmacologic classes 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 Hydrobromide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35916-0461-1 Dextromethorphan Hydrobromide 20 in 1 BOTTLE CAPSULE, LIQUID FILLED 20 5 35916-0461-2 Dextromethorphan Hydrobromide 1000 in 1 BAG CAPSULE, LIQUID FILLED 1000 5 35916-0461-3 Dextromethorphan Hydrobromide 3000 in 1 POUCH CAPSULE, LIQUID FILLED 3000 5 35916-0461-3 Dextromethorphan Hydrobromide 2 in 1 BOX CAPSULE, LIQUID FILLED 2 5 35916-0461-4 Dextromethorphan Hydrobromide 2 in 1 BOX CAPSULE, LIQUID FILLED 2 5 35916-0461-4 Dextromethorphan Hydrobromide 1500 in 1 BAG CAPSULE, LIQUID FILLED 1500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35916-0461 DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD] 2 Current NDC, 6 package rows 20250321_20f7c1a9-fc4d-1f51-e063-6394a90a8be3.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 97 of 177 · 3,534 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 35916-0461-1 35916046101 20 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0461-1) 2024-09-11 No No Current 35916-0461-2 35916046102 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0461-2) 2025-03-18 No No Current 35916-0461-3 35916046103 2 POUCH in 1 BOX (35916-0461-3) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 2 pouch 2025-07-17 No No Current 35916-0461-4 35916046104 2 BAG in 1 BOX (35916-0461-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG 2 bag 2026-01-12 No No Current