Tukol Max Action Cold and Flu Nighttime Relief
- Product NDC
- 50066-520
- 11-digit product format
- 500660520
- Labeler code
- 50066
- Product ID
- 50066-520_d0742123-2ccf-4a19-901c-20b17db981f2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Genomma Lab USA
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-07-30
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 21.67; .667; .417 mg/mL; mg/mL; mg/mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 Max Action Cold and Flu Nighttime Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 21.67 mg/mL |
| DEXTROMETHORPHAN HYDROBROMIDE | .667 mg/mL |
| DOXYLAMINE SUCCINATE | .417 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1042675 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cf0987a3-2c1d-4f40-8551-df9a8e08cd3d | Available on FDA.report |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Health Smart Vaporizing Chest Rub | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Jell Pharmaceuticals Pvt Ltd. | d80cad8d-da4c-049d-e053-2a95a90ac20e | 2024-12-18 | Warnings | M012 |
| Afrin Original | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 8a97c012-6a47-4607-9389-58a4eed17b08 | 2024-12-18 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Orazen Inc | ecddaa3b-e18f-1c74-e053-2995a90ad86a | 2024-12-18 | Warnings | M012 |
| Rite Aid Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Rite Aid | dfedbef1-8062-432d-e053-2a95a90a09e9 | 2024-12-18 | Warnings | M012 |
| TheraCare Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | f7801843-f96c-710e-e053-6294a90a5086 | 2024-12-18 | Warnings | M012 |
| Rugby Chest Congestion Relief G450 | GUAIFENESIN | Rugby Laboratories | a6aa8cbd-21ff-4f84-b338-c05c2d46e6df | 2024-12-18 | Warnings | M012 |
| Refenesen Mucus Relief | GUAIFENESIN | Reese Pharmaceutical Co | 861dffb7-8bf4-4f03-bcc2-ed8a35bc341d | 2024-12-18 | Warnings | M012 |
| Marcs Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Marc Glassman Inc | be3ad54f-522c-440d-b8c7-9664f6015566 | 2024-12-18 | Warnings | M012 |
| Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee | 2024-12-18 | Warnings | M012 |
| Family Wellness Chest Congestion Relief | GUAIFENESIN | Family Dollar Services Inc | 412f3459-4c22-4822-86bd-011fc3e91ca6 | 2024-12-18 | Warnings | M012 |
| Marcs Mucus Relief | GUAIFENESIN | Marc Glassman Inc | 455b9f01-206c-4534-a006-292d2bd48f47 | 2024-12-18 | Warnings | M012 |
| Leader Chest Congestion Relief G450 | GUAIFENESIN | Cardinal Health | 4586a83f-077c-4fb3-adfe-7a9497a78d97 | 2024-12-18 | Warnings | M012 |
| Foster and Thrive Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 5372f764-985e-4a42-bc97-cb0dc90fcd9c | 2024-12-18 | Warnings | M012 |
| TopCare Chest Congestion and Cough Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | TOPCO ASSOCIATES LLC | 5a2d0464-038d-4c3f-b39e-ee9984fb383e | 2024-12-18 | Warnings | M012 |
| Always Save Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Valu Merch | a72b6a97-f97f-44bb-8d55-ac48b8ba45c5 | 2024-12-18 | Warnings | M012 |
| Harris Teeter Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 4ebe1d94-bb15-4250-a4c2-8cd45743c7dd | 2024-12-18 | Warnings | M012 |
| Care One Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | RETAIL BUSINESS SERVICES , LLC | f6657dee-9f32-45b1-8e44-1ad67a4a68bd | 2024-12-18 | Warnings | M012 |
| Childrens Metapp Daytime | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Guardian Drug Company | 40565500-944b-47f2-8563-5df05469e418 | 2024-12-18 | Warnings | M012 |
| CVS Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | CVS Pharmacy, Inc. | 884abed2-e355-4134-92f1-591f3a18f71d | 2024-12-18 | Warnings | M012 |
| CVS Health Chest Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | CVS Pharmacy, Inc. | a49020e8-739e-47ec-8141-e866479a3ab3 | 2024-12-18 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 50066-520-06 | 50066052006 | 1 BOTTLE, PLASTIC in 1 CARTON (50066-520-06) / 177 mL in 1 BOTTLE, PLASTIC | 2026-07-30 | No | No | Current |