Home NDC 35916-0154 Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
Product NDC 35916-0154
11-digit product format 359160154
Labeler code 35916
Product ID 35916-0154_47c7c8ae-62c2-383d-e063-6294a90a15fe
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Softgel Healthcare Private Limited
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-27
Substance ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 6.25; 15 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 Hydrobromide and Doxylamine Succinate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup V9BI9B5YI2 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 1094549 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 35916-0154-1 Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 2 35916-0154-1 Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35916-0154 ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PRIVATE LIMITED] 1 Current NDC, 2 package rows 20240928_229d1939-84a9-f18e-e063-6394a90aba30.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 73 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 35916-0154-1 35916015401 1 BLISTER PACK in 1 CARTON (35916-0154-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2024-09-27 No No Current