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 |
|---|---|---|---|---|---|---|
| Cough Drops Honey Lemon with Sugar | MENTHOL | Lidl US LLC | 4ad9398f-7488-6eaf-e054-00144ff8d46c | 2024-11-05 | Warnings | M012 |
| rexall dm cough and congestion relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dolgencorp, LLC | 906838b1-a742-4728-944d-42b687b8cd59 | 2024-11-05 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | H E B | 7c24c59c-7549-4c64-95f8-4bf755cd6f61 | 2024-11-05 | Warnings | M012 |
| equate adult tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Wal-Mart Stores Inc | 3592e000-a6c6-47fe-8bb0-9341c65c2959 | 2024-11-05 | Warnings | M012 |
| tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Walgreen Company | 756794b0-8d3b-4732-947c-a407caf400e2 | 2024-11-05 | Warnings | M012 |
| basic care tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Amazon.com Services LLC | c6863e31-e1b9-40ff-ae2e-4aec86b4acc0 | 2024-11-05 | Warnings | M012 |
| topcare tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Topco Associates LLC | 94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a | 2024-11-05 | Warnings | M012 |
| Childrens Sudafed PE NASAL DECONGESTANT | PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d | 2024-11-04 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | 164b2559-2d3f-431e-a03c-07e86731af5c | 2024-11-04 | Warnings | M012 |
| tussin severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | 7cc2c136-d1b7-4658-99bb-73bb1d140261 | 2024-11-04 | Warnings | M012 |
| dg health tussin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | a5d0ee70-d528-4a53-bf01-7bb13b364ed0 | 2024-11-04 | Warnings | M012 |
| basic care tussin cf severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | bba9a17d-eb87-46f3-acee-c9dd34e5bfd4 | 2024-11-04 | Warnings | M012 |
| topcare tussin cf max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | b553b7e6-933b-49e3-97d3-22a4643a04b9 | 2024-11-04 | Warnings | M012 |
| dg health nasal original | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | fb209752-705a-4bb0-9298-8b70357f3911 | 2024-11-02 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | H E B | 3c301993-642a-487c-96a2-ebc4ef90dc88 | 2024-11-02 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 1341744c-43c3-462b-b93c-1e46476fd935 | 2024-11-01 | Warnings | M012 |
| Nighttime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 43784616-1afd-4ff7-8fee-6ac389f616a2 | 2024-11-01 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates LLC | 28ef87e8-29e5-444d-b1f7-5c38a7f758d3 | 2024-11-01 | Warnings | M012 |
| Good Sense Severe NightTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L. Perrigo Company | 0e3c36c9-d45b-41b9-891d-a42d854295f9 | 2024-11-01 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 7dc3941a-e5f8-4caa-bae5-6a0d075295cb | 2024-11-01 | 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 |