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
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 100; 5 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

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
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1044949

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-534-042024-01-11C16284748780-10191ceaa-7135-198a-e063-dbdaa90aec3eTukol® Cough & Cold Honey Flavor Syrup
50066-534-042023-07-28C16284748780-10191ceaa-7135-198a-e063-dbdaa90aec3eTukol® Cough & Cold Honey Flavor Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-534-04Tukol Cough And Cold Honey Flavor118 mL in 1 BOTTLE, PLASTICSYRUP11852
50066-534-04Tukol Cough And Cold Honey Flavor1 in 1 CARTONSYRUP152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-534TUKOL COUGH AND COLD HONEY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GENOMMA LAB USA]52Current NDC, Legacy NDC, 2 package rows20241115_a4b333dc-58da-45db-87b6-6fcb8fb542b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044949dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSNa4b333dc-58da-45db-87b6-6fcb8fb542b852
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDa4b333dc-58da-45db-87b6-6fcb8fb542b852
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYa4b333dc-58da-45db-87b6-6fcb8fb542b852
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSYa4b333dc-58da-45db-87b6-6fcb8fb542b852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50066-534-04500660534041 BOTTLE, PLASTIC in 1 CARTON (50066-534-04) / 118 mL in 1 BOTTLE, PLASTIC2019-09-200000-00-00NoNoCurrent