Tukol A

Product NDC
50066-536
11-digit product format
500660536
Labeler code
50066
Product ID
50066-536_158e568c-c1da-4e77-a6a4-34062f86f1fc
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Genomma Lab USA, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-09
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; 50; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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 A
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL
GUAIFENESIN50 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1370205

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-536-24Tukol A118 mL in 1 BOTTLELIQUID1184

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-536TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]4Current NDC, Legacy NDC, 1 package rows20180101_651f0d7c-c76b-434d-95fd-427609b40b46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370205dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN651f0d7c-c76b-434d-95fd-427609b40b464
1370205dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD651f0d7c-c76b-434d-95fd-427609b40b464
1370205dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY651f0d7c-c76b-434d-95fd-427609b40b464
1370205dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY651f0d7c-c76b-434d-95fd-427609b40b464

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50066-536-2450066053624118 mL in 1 BOTTLE (50066-536-24) 118 ml2014-06-090000-00-00NoNoCurrent