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 |
|---|---|---|---|---|---|---|
| ACTIDOGESIC | DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN | ACTIPHARMA, LLC | 697da3f9-9888-4d41-ba83-87ca9bf1e54b | 2025-08-18 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0 | 2025-08-18 | Warnings | M012 |
| MAJOR NASAL DECONGESTANT | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | 4b78b9af-0975-43f8-8b44-daddef0478be | 2025-08-15 | Warnings | M012 |
| Dr Simi Mucus Relief Expectorant | GUAIFENESIN | Farmacias De Similares TX LLC | 3c6d0e75-a685-6020-e063-6294a90a5c1b | 2025-08-15 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 25bf4390-23f7-4bb6-b86e-c40eaf8d92da | 2025-08-15 | Warnings | M012 |
| Childrens Chewable Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2cac72be-4830-ad49-e063-6394a90a7832 | 2025-08-14 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTH | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AMERISOURCE BERGEN | 2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e | 2025-08-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walmart Inc. | 16fae164-28db-8ef1-e063-6294a90ab5da | 2025-08-12 | Warnings | M012 |
| Exchange Select Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | fbece335-a7e5-4732-a086-561b23741579 | 2025-08-12 | Warnings | M012 |
| MGC Health Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 779ddb89-b6e2-4bfb-bcb5-8c7ec916675a | 2025-08-12 | Warnings | M012 |
| Equaline Nasal | OXYMETAZOLINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | d7fa1720-eac4-4e82-9401-77215ce4f545 | 2025-08-12 | Warnings | M012 |
| Diabetic Tussin DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | MEDTECH PRODUCTS INC | a10a3b33-7503-4334-8ed7-2bb881df4327 | 2025-08-08 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health, Inc | 26a55d74-f772-5d17-e063-6394a90a5583 | 2025-08-07 | Warnings | M012 |
| Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | b7434978-44a8-4c51-979d-0bc446461e43 | 2025-08-06 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | fc1e224c-5c57-43fc-ae6e-36aa0a4ae439 | 2025-08-06 | Warnings | M012 |
| childrens cold cough dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Publix Super Markets Inc | 6efe7097-2a99-4654-9d94-b47f2e64d19d | 2025-08-05 | Warnings | M012 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Chain Drug Marketing Association, Inc. | 3b7548ee-7cd3-62c3-e063-6294a90a0612 | 2025-08-03 | Warnings | M012 |
| Vaporizing chest rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | LJ Pharma | 065bb666-e482-4e96-ac75-c6577dcc5b48 | 2025-08-01 | Warnings | M012 |
| Nighttime Cough-Kids | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Genexa | 024bb864-4214-1d8b-e063-6394a90aa573 | 2025-08-01 | Warnings | M012 |
| Antigrip Cough and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Pharmadel LLC | 3b53e5fc-f258-c2b9-e063-6394a90ab500 | 2025-08-01 | 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 |