FDA.reportPublic FDA data

Tukol Honey Daytime Cold and Flu

Product NDC
50066-302
11-digit product format
500660302
Labeler code
50066
Product ID
50066-302_24fd90bc-bb83-4862-e063-6394a90a54c6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Genomma Lab USA
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-09
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
21.667; .667; .333 mg/mL; mg/mL; mg/mL
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

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 Honey Daytime Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN21.667 mg/mL
DEXTROMETHORPHAN HYDROBROMIDE.667 mg/mL
PHENYLEPHRINE HYDROCHLORIDE.333 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal 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
1113705Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9572b16-8e28-4f98-bd87-8a07721a49c6Available 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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-302-042024-01-11C16284748780-10191ceaa-70af-198a-e063-dbdaa90aec3eTukol ® Honey Daytime Cold & Flu
50066-302-042023-07-28C16284748780-10191ceaa-70af-198a-e063-dbdaa90aec3eTukol ® Honey Daytime Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-302-04Tukol Honey Daytime and Nighttime Value Pack118 mL in 1 BOTTLE, PLASTICSYRUP118 mL21.667 mg in 1mL8
50066-302-04Tukol Honey Daytime Cold and Flu1 in 1 CARTONSYRUP18
50066-302-04Tukol Honey Daytime Cold and Flu118 mL in 1 BOTTLE, PLASTICSYRUP1188
50066-302-04Tukol Honey Daytime and Nighttime Value Pack1 in 1 CARTONSYRUP21.667 mg in 1mL8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-302TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [GENOMMA LAB USA]8Current NDC, Legacy NDC20241024_bccc11d2-d227-4cbb-b0fc-ac6abb6dce57.zip
50066-302TUKOL HONEY DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GENOMMA LAB USA]8Current NDC, Legacy NDC, 2 package rows20241023_c9572b16-8e28-4f98-bd87-8a07721a49c6.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 44 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Wild Cherry Throat DropPECTINWalmart4d66547a-b72a-a0ac-e063-6394a90adc712026-03-19WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATESafeway, Inc.45d44cd2-5187-4a5c-983a-edb1e8eba0b22026-03-19WarningsExact identifier
application number: M012
Sedalmex XL FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBelmora LLCf2edfedf-e06e-4d1b-8c2d-732e08ec113c2026-03-19WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINBryant Ranch Prepack1e9887f6-209f-4f1f-9afa-a5ca649721cb2026-03-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamora Inc.5a7bf4cd-1d44-424d-9ef4-d484e626e3262026-03-18WarningsExact identifier
application number: M012
Harris Teeter Menthol Cough DropsMENTHOLHarris Teeter4d502c1f-7307-ac50-e063-6294a90a6ff42026-03-18WarningsExact identifier
application number: M012
Harris Teeter Cherry Cough DropsMENTHOLHarris Teeter4d50cc62-c84f-0761-e063-6394a90af54a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter Honey Lemon Cough DropsMENTHOLHarris Teeter4d516fce-d219-eee9-e063-6294a90ac59a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter SF Honey Lemon Cough DropsMENTHOLHarris Teeter4d524b45-260e-7411-e063-6294a90af6392026-03-18WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack9a77465c-6d3a-4399-9734-ad22e4b435db2026-03-18WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPreferred Pharmaceuticals Inc.a56d2fe4-5bea-4668-8e66-5a6f4279d4612026-03-18WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leader4136e5f4-cc00-46d6-aa7f-ef56d087d7ec2026-03-18WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf9a0fb35-46d6-434f-8f9a-425a4bf50e842026-03-18WarningsExact identifier
application number: M012
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEGrocery Outlet7398a372-7679-423b-a3ca-8da905a979dd2026-03-17WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGrocery Outlet0661ddeb-6289-471e-af89-7f4b7452c3552026-03-16WarningsExact identifier
application number: M012
Daytime Cold and Cough Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS2cf361eb-6055-2364-e063-6294a90a69a12026-03-16WarningsExact identifier
application number: M012
Severe Cold and Flu Relief Daytime/NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYb024ab38-e5da-4f5a-888f-e2a2815782902026-03-16WarningsExact identifier
application number: M012
good neighbor pharmacy night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen41f87d59-3245-46dc-88a8-b947675a90fc2026-03-16WarningsExact identifier
application number: M012
Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCLCVS2bc3eae8-ffe6-bc96-e063-6394a90a22832026-03-16WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP23e2d2dc-12d4-294d-e063-6394a90a95232026-03-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637726{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } PackGPCKbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) PackPSNbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNc9572b16-8e28-4f98-bd87-8a07721a49c68
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDc9572b16-8e28-4f98-bd87-8a07721a49c68
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) PackSYbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYc9572b16-8e28-4f98-bd87-8a07721a49c68
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYc9572b16-8e28-4f98-bd87-8a07721a49c68
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYbccc11d2-d227-4cbb-b0fc-ac6abb6dce578
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYc9572b16-8e28-4f98-bd87-8a07721a49c68
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYbccc11d2-d227-4cbb-b0fc-ac6abb6dce578

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50066-302-04500660302041 BOTTLE, PLASTIC in 1 CARTON (50066-302-04) / 118 mL in 1 BOTTLE, PLASTIC2020-02-090000-00-00NoNoCurrent