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 |
|---|---|
| ACETAMINOPHEN | 21.667 mg/mL |
| DEXTROMETHORPHAN HYDROBROMIDE | .667 mg/mL |
| PHENYLEPHRINE HYDROCHLORIDE | .333 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1113705 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c9572b16-8e28-4f98-bd87-8a07721a49c6 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50066-302-04 | 2024-01-11 | C162847 | 48780-1 | 0191ceaa-70af-198a-e063-dbdaa90aec3e | Tukol ® Honey Daytime Cold & Flu |
| 50066-302-04 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-70af-198a-e063-dbdaa90aec3e | Tukol ® Honey Daytime Cold & Flu |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50066-302-04 | Tukol Honey Daytime and Nighttime Value Pack | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 mL | 21.667 mg in 1mL | 8 |
| 50066-302-04 | Tukol Honey Daytime Cold and Flu | 1 in 1 CARTON | SYRUP | 1 | 8 | |
| 50066-302-04 | Tukol Honey Daytime Cold and Flu | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 | 8 | |
| 50066-302-04 | Tukol Honey Daytime and Nighttime Value Pack | 1 in 1 CARTON | SYRUP | 21.667 mg in 1mL | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50066-302 | TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [GENOMMA LAB USA] | 8 | Current NDC, Legacy NDC | 20241024_bccc11d2-d227-4cbb-b0fc-ac6abb6dce57.zip |
| 50066-302 | TUKOL HONEY DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GENOMMA LAB USA] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241023_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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL 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) } Pack | GPCK | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 2637726 | 1 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) Pack | PSN | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | c9572b16-8e28-4f98-bd87-8a07721a49c6 | 8 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | c9572b16-8e28-4f98-bd87-8a07721a49c6 | 8 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 2637726 | 1 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) Pack | SY | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | c9572b16-8e28-4f98-bd87-8a07721a49c6 | 8 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | c9572b16-8e28-4f98-bd87-8a07721a49c6 | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | c9572b16-8e28-4f98-bd87-8a07721a49c6 | 8 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50066-302-04 | 50066030204 | 1 BOTTLE, PLASTIC in 1 CARTON (50066-302-04) / 118 mL in 1 BOTTLE, PLASTIC | 2020-02-09 | 0000-00-00 | No | No | Current |