FDA.reportPublic FDA data

Tukol Sugar Free Cough and Cold

Product NDC
50066-505
11-digit product format
500660505
Labeler code
50066
Product ID
50066-505_23f8271b-e6f1-8897-e063-6394a90a9c82
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Guaifenesin
Dosage form
SYRUP
Route
ORAL
Labeler
Genomma Lab USA
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-13
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
2; 20 mg/mL; mg/mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tukol Sugar Free Cough and Cold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE2 mg/mL
GUAIFENESIN20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui996520

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-505-04Tukol Sugar Free Cough and Cold1 in 1 CARTONSYRUP13
50066-505-04Tukol Sugar Free Cough and Cold118 mL in 1 BOTTLE, PLASTICSYRUP1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-505TUKOL SUGAR FREE COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SYRUP [GENOMMA LAB USA]3Current NDC, 2 package rows20241010_95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN95e0a3eb-5a58-4c8b-a70b-fb0cca1e08413
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD95e0a3eb-5a58-4c8b-a70b-fb0cca1e08413
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY95e0a3eb-5a58-4c8b-a70b-fb0cca1e08413
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY95e0a3eb-5a58-4c8b-a70b-fb0cca1e08413
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY95e0a3eb-5a58-4c8b-a70b-fb0cca1e08413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50066-505-04500660505041 BOTTLE, PLASTIC in 1 CARTON (50066-505-04) / 118 mL in 1 BOTTLE, PLASTIC2024-06-13NoNoCurrent