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
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 Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1113705 |
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 |
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 |