Home NDC 85786-602 Dr. Simi Nighttime Cold and Flu
Product NDC 85786-602
11-digit product format 857860602
Labeler code 85786
Product ID 85786-602_4e5772ee-586d-6191-e063-6294a90a132d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine Succinate 6.25 mg
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Farmacias De Similares TX LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN
Active strength 15; 6.25; 325 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 Dr. Simi Nighttime Cold and Flu
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 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 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 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 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 85786-602-24 Dr. Simi Nighttime Cold and Flu 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 1 85786-602-24 Dr. Simi Nighttime Cold and Flu 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 1
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 85786-602-24 85786060224 2 BLISTER PACK in 1 CARTON (85786-602-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2026-03-30 No No Current