Home NDC 35916-0167 Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride
Product NDC 35916-0167
11-digit product format 359160167
Labeler code 35916
Product ID 35916-0167_47c7e929-e897-88c0-e063-6394a90a5821
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler SOFTGEL HEALTHCARE PRIVATE LIMITED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-22
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE
Active strength 325; 10; 5; 6.25 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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, Doxylamine Succinate and Phenylephrine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1297288 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 35916-0167-1 Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 3 35916-0167-1 Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35916-0167 ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD] 2 Current NDC, 2 package rows 20240827_1fcbafaa-c871-db6d-e063-6394a90aab5e.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 35916-0167-1 35916016701 2 BLISTER PACK in 1 CARTON (35916-0167-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2024-08-22 No No Current