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 |
|---|---|---|---|---|---|---|
| Optase | GLYCERIN | Scope Health Inc | 86c14327-ffc7-806e-e053-2991aa0aaf92 | 2026-01-29 | Warnings | PDC6A3C0OX |
| Night Time Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | e7dd763b-3005-4723-933b-171eb772afee | 2026-01-29 | Warnings | 9D2RTI9KYH |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | P & L Development, LLC | a397799d-46a6-447b-9498-17436d218e29 | 2026-01-28 | Warnings | 9D2RTI9KYH |
| Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 24bc9ae6-8e8f-c0a0-e063-6394a90a407f | 2026-01-28 | Warnings | 9D2RTI9KYH |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 229d1939-84a9-f18e-e063-6394a90aba30 | 2026-01-28 | Warnings | 9D2RTI9KYH |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1fcbafaa-c871-db6d-e063-6394a90aab5e | 2026-01-28 | Warnings | 9D2RTI9KYH |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1f7a6375-ab66-9782-e063-6394a90a99f3 | 2026-01-28 | Warnings | 9D2RTI9KYH |
| ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | MEDWISE LIFESCIENCES INC. | 4970b8bc-3c7b-4b8a-e063-6294a90a7f1b | 2026-01-28 | Warnings | 9D2RTI9KYH |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | Atlantic Biologicals Corp. | 42d837ae-2578-46df-92d2-24774964aaad | 2026-01-28 | Adverse reactions | 1Q73Q2JULR |
| Regener-Eyes Ophthalmic Solution PROFESSIONAL | GLYCERIN OPHTHALMIC SOLUTION | M & M PRODUCTS, LLC | 49771efa-6682-51d0-e063-6294a90a18a5 | 2026-01-28 | Warnings | PDC6A3C0OX |
| Regener-Eyes Ophthalmic Solution LITE | GLYCERIN OPHTHALMIC SOLUTION | M & M PRODUCTS, LLC | 497763ee-dc70-bb48-e063-6294a90afb3d | 2026-01-28 | Warnings | PDC6A3C0OX |
| Daytime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | fe3e74ba-31d9-4d50-ab61-ffb6aaa66085 | 2026-01-28 | Warnings | 9D2RTI9KYH |
| Leader Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. dba Leader | 9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5 | 2026-01-28 | Warnings | 9D2RTI9KYH |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 93d5b1db-e9ad-4a6a-b869-fd0d1a11df02 | 2026-01-27 | Warnings | 9D2RTI9KYH |
| mucus relief d | GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE | H E B | 80acd350-7c96-4620-bd7c-848c85f157ed | 2026-01-27 | Warnings | 6V9V2RYJ8N |
| cough dm | DEXTROMETHORPHAN POLISTIREX | HyVee Inc | 20c10d74-0435-4e8a-acd7-5af1f8382c28 | 2026-01-27 | Warnings | 9D2RTI9KYH |
| Dextromethorphan Hbr,Guaifenesin | DEXTROMETHORPHAN HBR,GUAIFENESIN | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2fbbfc7c-81a9-b647-e063-6394a90a55ac | 2026-01-27 | Warnings | 9D2RTI9KYH |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 37e8ccd5-6be1-9aca-e063-6394a90a5263 | 2026-01-27 | Warnings | 9D2RTI9KYH |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2f7f078e-de04-9d53-e063-6394a90a409f | 2026-01-27 | Warnings | 9D2RTI9KYH |
| XL-3 Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rnv LLC | 03210929-331e-462d-b566-4e1865f52246 | 2026-01-27 | Warnings | 9D2RTI9KYH |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.