Home NDC 50066-520 Tukol Max Action Cold and Flu Nighttime Relief
Product NDC 50066-520
11-digit product format 500660520
Labeler code 50066
Product ID 50066-520_d0742123-2ccf-4a19-901c-20b17db981f2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate
Dosage form SYRUP
Route ORAL
Labeler Genomma Lab USA
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-30
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 21.67; .667; .417 mg/mL; mg/mL; mg/mL
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 Tukol Max Action Cold and Flu Nighttime Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 21.67 mg/mL DEXTROMETHORPHAN HYDROBROMIDE .667 mg/mL DOXYLAMINE SUCCINATE .417 mg/mL
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 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1042675 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50066-520-06 50066052006 1 BOTTLE, PLASTIC in 1 CARTON (50066-520-06) / 177 mL in 1 BOTTLE, PLASTIC 2026-07-30 No No Current