FDA.reportPublic FDA data

Tukol Honey Children Cough and Congestion

Product NDC
50066-301
11-digit product format
500660301
Labeler code
50066
Product ID
50066-301_24c1f740-5460-0dad-e063-6394a90a8fa0
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
2020-02-09
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; 50; 2.5 mg/2.5mL; mg/2.5mL; mg/2.5mL
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50066-301-04fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50066-301-0486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50066-301-04bd6a592717d7…303034d00443…

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 Children Cough and Congestion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/2.5mL
GUAIFENESIN50 mg/2.5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/2.5mL

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
dae33df8-2294-4242-a25b-2d89d1f63b23Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-01-11Tukol ® Honey Children Cough & Congestion
2023-07-28Tukol ® Honey Children Cough & Congestion
2022-12-28Tukol ® Honey Children Cough & Congestion
2022-01-28Tukol ® Honey Children Cough & Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-301-04Tukol Honey Children Cough and Congestion1 in 1 CARTONSYRUP16
50066-301-04Tukol Honey Children Cough and Congestion118 mL in 1 BOTTLE, PLASTICSYRUP1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-301TUKOL HONEY CHILDREN COUGH AND CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GENOMMA LAB USA]6Current NDC, Legacy NDC, 2 package rows20241020_dae33df8-2294-4242-a25b-2d89d1f63b23.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 20 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC319e84fd-4033-f5eb-e063-6394a90aa2f32026-06-27WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLHY-VEE, INC47a6f3c3-a6fa-dd61-e063-6394a90a49652026-06-26WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLHY-VEE, INC47a717e9-56b3-e771-e063-6394a90a5c172026-06-26WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5532fd37-cdd6-97ab-e063-6394a90a3c772026-06-26WarningsExact identifier
application number: M012
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5533e705-b8d5-71cf-e063-6394a90a20102026-06-26WarningsExact identifier
application number: M012
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals265f1ce7-160c-4dda-b2e0-b78d68f962bd2026-06-26WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEBryant Ranch Prepackee052b39-1658-4071-b081-5433c87b5e4a2026-06-25WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLDOLGENCORP, LLCfae1499a-7029-4208-8436-4d330347b9152026-06-25WarningsExact identifier
application number: M012
Sinus Pressure and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC4fe8f124-ac80-40b4-8e1d-96709c459a4f2026-06-25WarningsExact identifier
application number: M012
Allergy and Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE91268cd0-c151-4744-a715-a57af3f3a3142026-06-25WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea2026-06-24WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEcb475e7f-aec1-415d-9770-07cce4e02c072026-06-24WarningsExact identifier
application number: M012
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
application number: M012
Neo-Synephrine SeverePHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC54edaff7-d241-dc90-e063-6294a90ac64d2026-06-23WarningsExact identifier
application number: M012
AXIV Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC4b81abf9-3ea7-e996-e063-6394a90a71e82026-06-23WarningsExact identifier
application number: M012
AXIV Sinus OVERNIGHTOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC54e03a63-f978-33d4-e063-6394a90a30f22026-06-23WarningsExact identifier
application number: M012
equaline daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI9a199782-5d7e-449b-a86c-969746f0e96f2026-06-23WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Company542b9861-8055-45f6-8cbf-9fe5cde1c4d92026-06-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact 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 SolutionPSNdae33df8-2294-4242-a25b-2d89d1f63b236
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDdae33df8-2294-4242-a25b-2d89d1f63b236
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYdae33df8-2294-4242-a25b-2d89d1f63b236
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSYdae33df8-2294-4242-a25b-2d89d1f63b236

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50066-301-04500660301041 BOTTLE, PLASTIC in 1 CARTON (50066-301-04) / 118 mL in 1 BOTTLE, PLASTIC2020-02-090000-00-00NoNoCurrent