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 |
|---|---|---|---|---|---|---|
| Non-Drowsy Max Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATED | Lil' Drug Store Products, Inc. | e79f1a92-d8ea-e3f9-e053-2a95a90a2d37 | 2023-12-14 | Warnings | 9D2RTI9KYH |
| Systane COMPLETE PF | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 7eaa93ca-c843-4c89-921b-c76659410dce | 2023-12-14 | Warnings | 6DC9Q167V3 |
| GenTeal Tears Gel Drops | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 84388a75-9d11-48ce-bf5a-88f0580d2d03 | 2023-12-14 | Warnings | 6DC9Q167V3 |
| BSS | BALANCED SALT SOLUTION | Alcon Laboratories, Inc. | 28488c7b-cf6a-4a03-916f-cc66b3afdc57 | 2023-12-14 | Warnings, Adverse reactions | 1Q73Q2JULR |
| La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant | GLYCERIN | L'Oreal USA Products Inc | 32eaaaab-41bd-4efe-a71d-92e3a702c1e5 | 2023-12-11 | Warnings | PDC6A3C0OX |
| Family Wellness HEMORRHOID | GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL | FAMILY DOLLAR (Family Wellness) | 16ceb129-5c0a-428a-a867-cfbbb08bb62a | 2023-12-11 | Warnings | PDC6A3C0OX |
| La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 | GLYCERIN | Cosmetique Active Production | 01c8a0d5-bcd1-4639-be45-530a226401f0 | 2023-12-11 | Warnings | PDC6A3C0OX |
| Oracit | CITRIC ACID AND SODIUM CITRATE | CMP Pharma, Inc. | bc26abed-8e6e-475d-8ab3-abf7d0377003 | 2023-12-07 | Adverse reactions | 2968PHW8QP |
| Childrens Plus Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 1598e6f8-08ee-4216-a5ab-76cad37b09a7 | 2023-12-06 | Warnings | 9D2RTI9KYH |
| Hemorrhoidal Pain Relief Cream | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | WALGREENS | 03bbe146-f185-bcfa-e063-6394a90a85bf | 2023-12-04 | Warnings | PDC6A3C0OX |
| Eye Wash | WATER | Jiangxi Zhenmei Biological Technology Co.,Ltd | c68795b8-bf68-0d01-e053-2a95a90abebb | 2023-12-04 | Warnings | 059QF0KO0R |
| Stona-S | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1 | 2023-12-04 | Warnings | 9D2RTI9KYH |
| Stona Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | afc95c82-18da-487b-b4bb-51e0be0378da | 2023-12-04 | Warnings | 9D2RTI9KYH |
| TopCare Day Time SEVERE Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 14d53907-a4a2-4a0f-b2d6-33474945f9e1 | 2023-12-04 | Warnings | 9D2RTI9KYH |
| Sanatos Multi Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Pharmadel LLC | 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9 | 2023-12-01 | Warnings | 9D2RTI9KYH |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Meijer | c051be4b-88c9-e56f-e053-2995a90a3aa8 | 2023-12-01 | Warnings | 6V9V2RYJ8N |
| Mucus Relief DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Ahold U.S.A., Inc, | 738bbea4-4243-4cbd-980e-a22451b85c4c | 2023-12-01 | Warnings | 9D2RTI9KYH |
| Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Winco Foods, LLC. | ac1c8633-4064-4e2f-9b43-4ae9bdd1a427 | 2023-12-01 | Warnings | 9D2RTI9KYH |
| Mucus Relief DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Ahold U.S.A., Inc, | e9add770-58e0-4cf3-bbc2-d293ca870b03 | 2023-12-01 | Warnings | 9D2RTI9KYH |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | KROGER COMPANY | b97aeb2c-07ac-d00e-e053-2a95a90abf40 | 2023-12-01 | Warnings | 6V9V2RYJ8N |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.