FDA.reportPublic FDA data

Tukol Multi Symptom Cold

Product NDC
50066-504
11-digit product format
500660504
Labeler code
50066
Product ID
50066-504_4c7fab8b-ba17-4210-9f16-05fdac6cf62b
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Genomma Lab USA, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-05-15
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

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 Multi Symptom Cold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1044949Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aef2ad43-145d-4abc-bccc-2c5fdd6882f9Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-504-24Tukol Multi Symptom Cold118 mL in 1 BOTTLELIQUID1186

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
GUAIFENESINACTIVE INGREDIENT495W7451VQTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RTUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-504TUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]6Current NDC, Legacy NDC, 1 package rows20241222_aef2ad43-145d-4abc-bccc-2c5fdd6882f9.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 54 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services, LLC1d6c23d7-d1dc-4cba-8600-5762c18a0e272026-01-29WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLBelmora LLC3622e072-2784-c57e-e063-6394a90a82172026-01-29Warnings, Adverse reactionsExact identifier
application number: M012
Night Time Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLCe7dd763b-3005-4723-933b-171eb772afee2026-01-29WarningsExact identifier
application number: M012
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBrACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd24bc9ae6-8e8f-c0a0-e063-6394a90a407f2026-01-28WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited229d1939-84a9-f18e-e063-6394a90aba302026-01-28WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED1fcbafaa-c871-db6d-e063-6394a90aab5e2026-01-28WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED1f7a6375-ab66-9782-e063-6394a90a99f32026-01-28WarningsExact identifier
application number: M012
ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIMEDWISE LIFESCIENCES INC.4970b8bc-3c7b-4b8a-e063-6294a90a7f1b2026-01-28WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBRFamily Dollar (FAMILY WELLNESS)fe3e74ba-31d9-4d50-ab61-ffb6aaa660852026-01-28WarningsExact identifier
application number: M012
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leader9b1a5dbe-39dd-4dbb-800c-0cef422ae7c52026-01-28WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company93d5b1db-e9ad-4a6a-b869-fd0d1a11df022026-01-27WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc53a3e6a7-d625-4393-95eb-bb6f86e86cc12026-01-27WarningsExact identifier
application number: M012
Dextromethorphan Hbr,GuaifenesinDEXTROMETHORPHAN HBR,GUAIFENESINSOFTGEL HEALTHCARE PRIVATE LIMITED2fbbfc7c-81a9-b647-e063-6394a90a55ac2026-01-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED32074a31-326b-4aaf-e063-6394a90a0d402026-01-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED335b6ddd-fdc8-1120-e063-6394a90add412026-01-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED37e8ccd5-6be1-9aca-e063-6394a90a52632026-01-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATESOFTGEL HEALTHCARE PRIVATE LIMITED2f7f078e-de04-9d53-e063-6394a90a409f2026-01-27WarningsExact identifier
application number: M012
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M012
XL-3 Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERnv LLC03210929-331e-462d-b566-4e1865f522462026-01-27WarningsExact identifier
application number: M012
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRnv LLC2381ff41-4584-4b38-839f-f94e733f5bf22026-01-27WarningsExact identifier
application number: M012

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 SolutionPSNaef2ad43-145d-4abc-bccc-2c5fdd6882f96
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDaef2ad43-145d-4abc-bccc-2c5fdd6882f96
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYaef2ad43-145d-4abc-bccc-2c5fdd6882f96
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSYaef2ad43-145d-4abc-bccc-2c5fdd6882f96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50066-504-2450066050424118 mL in 1 BOTTLE (50066-504-24) 118 ml2012-05-150000-00-00NoNoCurrent