FDA.reportPublic FDA data

Tukol Max Action Cold, Flu and Sore Throat

Product NDC
50066-313
11-digit product format
500660313
Labeler code
50066
Product ID
50066-313_f08e85d5-e94d-495d-ba72-523f794052c7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Genomma Lab USA
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-21
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
32.5; 1; 20; .5 mg/mL; mg/mL; mg/mL; mg/mL
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 Max Action Cold, Flu and Sore Throat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN32.5 mg/mL
DEXTROMETHORPHAN HYDROBROMIDE1 mg/mL
GUAIFENESIN20 mg/mL
PHENYLEPHRINE HYDROCHLORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1116572

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
50066-313-062024-06-20C16284748780-10191ceaa-6878-198a-e063-dbdaa90aec3eTukol ® Max Action Cold, Flu and Sore Throat
50066-313-062023-07-28C16284748780-10191ceaa-6878-198a-e063-dbdaa90aec3eTukol ® Max Action Cold, Flu and Sore Throat

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-313-06Tukol Max Action Cold, Flu and Sore Throat1 in 1 CARTONSYRUP12
50066-313-06Tukol Max Action Cold, Flu and Sore Throat177 mL in 1 BOTTLE, PLASTICSYRUP1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-313TUKOL MAX ACTION COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GENOMMA LAB USA]2Current NDC, Legacy NDC, 2 package rows20240621_aedce1f9-4902-4c51-92e0-6056196394c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNaedce1f9-4902-4c51-92e0-6056196394c22
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDaedce1f9-4902-4c51-92e0-6056196394c22
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYaedce1f9-4902-4c51-92e0-6056196394c22
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSYaedce1f9-4902-4c51-92e0-6056196394c22
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYaedce1f9-4902-4c51-92e0-6056196394c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50066-313-06500660313061 BOTTLE, PLASTIC in 1 CARTON (50066-313-06) / 177 mL in 1 BOTTLE, PLASTIC2024-06-210000-00-00NoNoCurrent