Home NDC 50066-534 Tukol Cough And Cold Honey Flavor
Product NDC 50066-534
11-digit product format 500660534
Labeler code 50066
Product ID 50066-534_26bab552-32fa-e4e1-e063-6394a90acefd
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Genomma Lab USA
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-09-20
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 100; 5; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 2026-12-31
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 Cough And Cold Honey Flavor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 04JA59TNSJ 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 1044949 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50066-534-04 Tukol Cough And Cold Honey Flavor 118 mL in 1 BOTTLE, PLASTIC SYRUP 118 52 50066-534-04 Tukol Cough And Cold Honey Flavor 1 in 1 CARTON SYRUP 1 52
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50066-534 TUKOL COUGH AND COLD HONEY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GENOMMA LAB USA] 52 Current NDC, Legacy NDC, 2 package rows 20241115_a4b333dc-58da-45db-87b6-6fcb8fb542b8.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 Marketing start Marketing end Sample Exclude flag Status 50066-534-04 50066053404 1 BOTTLE, PLASTIC in 1 CARTON (50066-534-04) / 118 mL in 1 BOTTLE, PLASTIC 2019-09-20 0000-00-00 No No Current