NDC 80587-183 - DURATUSS DM
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 80587-183
- Package NDCs from labels
- 80587-183-01, 80587-183-02
- Manufacturer
- Prime Labs LLC dba Quality CDMO
- Effective date
- 2025-11-19
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| DURATUSS DM - Prime Labs LLC dba Quality CDMO | Prime Labs LLC dba Quality CDMO | 2025-11-19 | HUMAN OTC DRUG LABEL |
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 |
|---|---|---|---|---|---|---|
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Aurohealth LLC | a1921611-343c-4c2a-846d-c8de19dddab5 | 2023-12-01 | Warnings | 9D2RTI9KYH |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | WALGREEN CO. | cc1ac1b4-cbc4-539c-e053-2a95a90a5b75 | 2023-12-01 | Warnings | 6V9V2RYJ8N |
| Mucus Relief DM Expectorant and Cough Suppressant | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Winco Foods, LLC. | e7e16bab-a7aa-4911-9a29-0c986b26da67 | 2023-12-01 | Warnings | 9D2RTI9KYH |
| Bloop Hemorrhoid Relief Topical | GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL | Three Nations Corp | 0b6419e3-f1c7-bdfe-e063-6294a90a5d92 | 2023-11-30 | Warnings | PDC6A3C0OX |
| Akin Cough Formula DM Strawberry Banana | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Southern Sales & Service, Inc. | 7a81efd8-775d-455e-860f-f3e3b369a0a7 | 2023-11-29 | Warnings | 9D2RTI9KYH |
| Akin Cough Formula DM | DEXTROMETHORPHAN, GUAIFENESIN | Southern Sales & Service, Inc. | 1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a | 2023-11-29 | Warnings | 9D2RTI9KYH |
| Stona | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | 8b89f50d-88f8-4773-92ea-5ada61766056 | 2023-11-28 | Warnings | 9D2RTI9KYH |
| Stona | DEXTROMETHORPHAN HYDROBROMIDE | Sato Pharmaceutical Co., Ltd. | 1ccc9e56-32a4-450f-8412-5814b6aef285 | 2023-11-28 | Warnings | 9D2RTI9KYH |
| Sanatos Multi Symptoms Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 0a60326a-a17b-e843-e063-6394a90ac211 | 2023-11-22 | Warnings | 9D2RTI9KYH |
| Sanatos Nighttime Multi Symptoms | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 0ab188f3-f7f9-d665-e063-6294a90a198a | 2023-11-22 | Warnings | 9D2RTI9KYH |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | A-S Medication Solutions | 786607e9-ee2d-4510-8556-857032e4053f | 2023-11-22 | Warnings | 9D2RTI9KYH |
| Phexxi | LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE | Evofem, Inc. | 173ff411-7227-47b0-94dc-844e1ebaf14e | 2023-11-21 | Warnings, Adverse reactions | 2968PHW8QP |
| Sanatos Multi Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI | Pharmadel LLC | 0ab11691-5b29-55fc-e063-6394a90aa328 | 2023-11-17 | Warnings | 9D2RTI9KYH |
| SanaTos X | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | 85b8ef3d-7318-7f3b-e053-2991aa0a0777 | 2023-11-14 | Warnings | 9D2RTI9KYH |
| Daytime Cold and Flu Severe, Caseys 4goog | ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 0334259d-587e-b2d5-e063-6394a90a3e56 | 2023-11-14 | Warnings | 9D2RTI9KYH |
| Stona Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Sato Pharmaceutical Co., Ltd. | 0b638db4-5ed3-4665-abcd-f95e677adbd8 | 2023-11-12 | Warnings | 9D2RTI9KYH |
| Tylenol Cold Plus Flu Severe Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | 8b8582c0-8aef-482f-9738-2f1d4e325d64 | 2023-11-06 | Warnings | 9D2RTI9KYH |
| TopCare Nite Time SEVERE Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | adc8edf5-ebbe-4d94-9018-aa0dbe118112 | 2023-11-03 | Warnings | 9D2RTI9KYH |
| Multi-Symptom Mapap Cold Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Proficient Rx LP | 9bf81b26-38b4-486c-ae89-222119ce1a4f | 2023-11-01 | Warnings | 9D2RTI9KYH |
| Guaifenesin Syrup and Dextromethorphan | GUAIFENESIN SYRUP AND DEXTROMETHORPHAN | Natco Pharma USA LLC | ad9026f4-f0b6-4d02-aa44-f0460eeefc0e | 2023-11-01 | Warnings | 9D2RTI9KYH |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.