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 |
|---|---|---|---|---|---|---|
| Maximum Strength-Cough and Chest Congestion DM | MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | d1830989-fe82-4f08-8618-78979fcef568 | 2024-11-25 | Warnings | 9D2RTI9KYH |
| ASP Daytime PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | b84f2392-0b24-4af0-80f7-c45454093f51 | 2024-11-25 | Warnings | 9D2RTI9KYH |
| ASP Nighttime Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | d8756d1f-baf5-412d-a493-a1c051eae302 | 2024-11-25 | Warnings | 9D2RTI9KYH |
| Ibuprofen and Pseudoephedrine Hydrochloride | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | d93ae778-e6e9-4d1d-8f46-c04d962a9393 | 2024-11-22 | Warnings | 6V9V2RYJ8N |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | a01abac3-c13e-40f2-ae98-34bd6c9b7504 | 2024-11-21 | Warnings | 9D2RTI9KYH |
| Dextromethorphan HBr 15 mg | DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 028b025e-2dde-4bef-ba7b-61774e855b4b | 2024-11-21 | Warnings | 9D2RTI9KYH |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | 856cb3c3-8f32-4285-8c13-25f01779a31a | 2024-11-21 | Warnings | 9D2RTI9KYH |
| Night Time Severe Cold and Flu Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 3375a059-2939-438e-92b5-a7f1952bbb22 | 2024-11-21 | Warnings | 9D2RTI9KYH |
| NiteTime Cold/Flu, Multi-Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 9033bf94-f444-4488-b717-050d04dee388 | 2024-11-21 | Warnings | 9D2RTI9KYH |
| Severe sinus Congestion Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | e173bec9-14df-4535-a023-47d8cda8d4ec | 2024-11-21 | Warnings | 9D2RTI9KYH |
| Instant Hand Sanitizeing Wipe | ISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTS | Shandong Yayun Sanitary Products Co., Ltd. | aa0dc01a-2c6b-7402-e053-2a95a90af6a2 | 2024-11-21 | Warnings | 6DC9Q167V3 |
| COLD FLU and SORE THROAT RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 1161e5dc-0677-4fb9-964f-971a508098b6 | 2024-11-21 | Warnings | 9D2RTI9KYH |
| Night Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Retail Business Services, LLC | fc8c70d6-6be5-4f12-84b0-125fc82149ec | 2024-11-21 | Warnings | 9D2RTI9KYH |
| DayTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5b55d1df-275b-40d8-bde3-fc43313b7eb3 | 2024-11-20 | Warnings | 9D2RTI9KYH |
| Baby Wipes | PROPYLENE GLYCOL | Shandong Yayun Sanitary Products Co., Ltd. | aeb9a12c-955f-5030-e053-2995a90a2dd6 | 2024-11-20 | Warnings | 6DC9Q167V3 |
| Potassium Citrate and Citric Acid | POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE | PAI Holdings, LLC dba PAI Pharma | ce42122f-8087-471f-b0a3-5524bdbd4526 | 2024-11-19 | Warnings, Adverse reactions | 2968PHW8QP |
| SanaTos Boost | DEXTROMETHORPHAN HBR | Pharmadel LLC | ae6a424f-f3f0-3f6c-e053-2995a90a972d | 2024-11-18 | Warnings | 9D2RTI9KYH |
| SanaTos Turbo Max Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Pharmadel LLC | d56a071c-a747-5397-e053-2995a90aad8b | 2024-11-18 | Warnings | 9D2RTI9KYH |
| cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | 404ef5f4-7b7b-4c08-b159-9175a91be132 | 2024-11-17 | Warnings | 9D2RTI9KYH |
| equaline childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | a24021a0-ef68-4bce-ba53-d262d1025cc0 | 2024-11-17 | Warnings | 9D2RTI9KYH |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.