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 |
|---|---|---|---|---|---|---|
| ORIGINAL Nasal PUMP MIST No Drip | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | ac27fd75-4fe4-433c-a434-2dac16c895c7 | 2026-08-07 | Warnings | M012 |
| Winco Foods Childrens Allergy Relief Dye Free | DIPHENHYDRAMINE HYDROCHLORIDE | WINCO FOODS, LLC | a1367804-37c9-4906-858f-8feeb748d8d3 | 2026-08-07 | Warnings | M012 |
| Severe Congestion Nasal Anti-Drip Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | a09c2d02-334a-4840-b2d0-327121cec994 | 2026-08-07 | Warnings | M012 |
| Daytime Nighttime Intense Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreen Company | 03aa43fd-4962-4c2c-9edd-e422a629a0e3 | 2026-08-06 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f311b56f-b959-4070-9b23-82c642dd98b8 | 2026-08-06 | Warnings | M012 |
| Cold Relief Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 2026-08-06 | Warnings | M012 |
| Eucamint | MENTHOL, CAMPHOR | Indiana Botanic Gardens | d79bc8de-9efb-4996-a55c-accda0f8edb2 | 2026-08-06 | Warnings | M012 |
| NICOTINE GUM | NICOTINE POLACRILEX | Guangzhou Shuimu Jiahe Trading Co., Ltd. | 4e88dab4-8e13-f074-e063-6394a90a3908 | 2026-08-06 | Warnings | M012 |
| Oneoo Nicotine Gum (Mint) | NICOTINE POLACRILEX | Guangzhou Shuimu Jiahe Trading Co., Ltd. | 54b1329b-b422-29a5-e063-6294a90a8780 | 2026-08-06 | Warnings | M012 |
| Sine Aid PEAK MISERY | OXYMETAZOLINE HYDROCHLORIDE | Infirst Healthcare Inc. | 586a2a14-7048-0c8b-e063-6394a90a65b7 | 2026-08-06 | Warnings | M012 |
| DRX CHOICE Daytime and Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Raritan Pharmaceuticals Inc | b745f45d-2042-4daa-9932-241836d7734b | 2026-08-06 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | NUVICARE LLC | 6713fdff-0e4e-4a9d-b218-34f786339c57 | 2026-08-06 | Warnings | M012 |
| Daytime Cold, Nighttime Cold multi-symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 3b462a5d-d48b-4b73-b5d4-d7944730bbdd | 2026-08-06 | Warnings | M012 |
| TOPCARE DAY TIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | d1b89d17-b3b9-4133-88a3-8cd7c4efafa9 | 2026-08-05 | Warnings | M012 |
| Sinufrin Quick Relief Decongestant | SINUFRIN | Neilmed pharmaceuticals Inc. | 0c36a34e-462d-713c-e063-6294a90a1776 | 2026-08-05 | Warnings | M012 |
| No Drip | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | e9b799ad-9164-7f30-e053-2a95a90a00c5 | 2026-08-05 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 507284c3-cad9-d65c-e063-6394a90a58a8 | 2026-08-05 | Warnings | M012 |
| cough and cold relief HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | United Natural Foods, Inc. dba UNFI | 90482e7a-d7c7-4127-972d-5ee55e55ed1c | 2026-08-04 | Warnings | M012 |
| DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | 78edeb7a-4712-4f04-9d76-d5b2d20ce76d | 2026-08-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Better Living Brands, LLC | 33f34aa2-3b37-4e51-8428-4a12708aa064 | 2026-08-04 | 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 |