Home NDC 35916-0188 Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg
Product NDC 35916-0188
11-digit product format 359160188
Labeler code 35916
Product ID 35916-0188_5003542f-a0ff-cd67-e063-6294a90aee97
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl
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 PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength 5; 10; 325 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [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 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 ACETAMINOPHEN 325 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086997 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 35916-0188-1 Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 1000 in 1 BAG CAPSULE, LIQUID FILLED 1000 5 35916-0188-2 Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 3000 in 1 POUCH CAPSULE, LIQUID FILLED 3000 5 35916-0188-2 Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 2 in 1 BOX CAPSULE, LIQUID FILLED 2 5 35916-0188-3 Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 2000 in 1 POUCH CAPSULE, LIQUID FILLED 2000 5 35916-0188-3 Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 2 in 1 BOX CAPSULE, LIQUID FILLED 2 5 35916-0188-4 Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 2 in 1 BOX CAPSULE, LIQUID FILLED 2 5 35916-0188-4 Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 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 35916-0188 ACETAMINOPHEN 325MG, DEXTROMETHORPHAN HBR 10MG AND PHENYLEPRINE HCL 5MG (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PRIVATE LIMITED] 1 Current NDC, 7 package rows 20250322_30ab39f3-27cc-5728-e063-6394a90a9cbe.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 35916-0188-1 35916018801 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0188-1) 2025-03-21 No No Current 35916-0188-2 35916018802 2 POUCH in 1 BOX (35916-0188-2) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 2 pouch 2025-06-12 No No Current 35916-0188-3 35916018803 2 POUCH in 1 BOX (35916-0188-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH 2 pouch 2025-09-25 No No Current 35916-0188-4 35916018804 2 BAG in 1 BOX (35916-0188-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG 2 bag 2026-01-13 No No Current