NDC 57237-313-01 - Dextromethorphan HBr. and Guaifenesin
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
- 57237-313
- Requested NDC
- 57237-313-01
- Package NDCs from labels
- 57237-313-01, 57237-313-18
- Manufacturer
- Rising Pharma Holdings, Inc.
- Effective date
- 2026-09-22
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Dextromethorphan HBr. and Guaifenesin - Rising Pharma Holdings, Inc. | Rising Pharma Holdings, Inc. | 2026-09-22 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-313-01 | Dextromethorphan HBr. and Guaifenesin | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | 5 | |
| 57237-313-18 | Dextromethorphan HBr. and Guaifenesin | 80 in 1 BOX, UNIT-DOSE | SOLUTION | 80 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-313-01 | ML - Milliliter | 57237-313 | b4b7f776-ef79-4ae7-91fd-645b4e7d702c | 1 | 2023-07-06 |
| 57237-313-18 | ML - Milliliter | 57237-313 | 1a032e32-c5d7-44b4-8e28-95a98c950ff8 | 1 | 2023-07-06 |
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 |
|---|---|---|---|---|---|---|
| Advil Targeted Relief | CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE | Haleon US Holdings LLC | 16e6be21-7b43-443a-89ec-3bdf0ec0dfc1 | 2024-02-08 | Warnings | L7T10EIP3A |
| Childrens Robitussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 15950273-14c9-4a0b-bbb4-683048add722 | 2024-02-08 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Guaifenesin Extended Release 600 mg | GUAIFENESIN | TIME CAP LABORATORIES, INC. | 10c42869-7df0-3046-e063-6394a90aa679 | 2024-02-07 | Warnings | 495W7451VQ |
| POINT RELIEF COLD SPOT Pain Relieving | MENTHOL | FABRICATION ENTERPRISES | 96f1d592-6cec-412e-a5fd-cf3c4f68644f | 2024-02-07 | Warnings | L7T10EIP3A |
| Pain Relieving Roll-On | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | 80118260-9c88-402d-9a90-ecfe62b4b54f | 2024-02-05 | Warnings | L7T10EIP3A |
| Pain Relieving | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | df512ce6-ce1b-434d-9571-fb2e1d76e1d0 | 2024-02-05 | Warnings | L7T10EIP3A |
| Pain Relieving | MENTHOL | Safetec of America, Inc. | 52ebf64d-095f-467e-bf51-dd8d33b58c7d | 2024-02-05 | Warnings | L7T10EIP3A |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | FSA Store Inc. (Caring Mills) | 57ade7e9-1c68-456c-8853-5acdef7e8f0e | 2024-02-05 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Analgesic | MENTHOL | Safetec of America, Inc. | 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802 | 2024-02-04 | Warnings | L7T10EIP3A |
| THERAFLU Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 7d902237-a990-4c5e-875b-291e124e143b | 2024-02-03 | Warnings | 9D2RTI9KYH |
| Maximum Strength Mucus Relief DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | WALGREEN CO. | 83483b91-77e5-42ca-a467-21312ef32d30 | 2024-02-03 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Mucus Relief DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Wal-Mart Stores, Inc. | 48ecf1f4-0571-4d7e-b0cc-309c88b7f1bf | 2024-02-03 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Aurohealth LLC | 029ee6fb-df76-4df6-b717-70005d5708da | 2024-02-03 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Mucus Relief DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | WALGREEN CO. | 40264f92-677e-481e-8d78-5577b2979b01 | 2024-02-03 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 0f2d371d-f890-41e5-ac11-db5559d32466 | 2024-02-02 | Warnings | 9D2RTI9KYH 495W7451VQ |
| CVS Health COUGH SUPPRESSANT SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE | CVS Pharmacy, Inc. | f676dfeb-fba8-419d-8a47-c3880e4100cc | 2024-02-02 | Warnings | 9D2RTI9KYH |
| Nighttime Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 155a7168-b568-41f4-b8a2-214889b4eccf | 2024-02-02 | Warnings | 9D2RTI9KYH |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | Rejoice International Corp. | 104e1a38-3472-b9e2-e063-6294a90a38cf | 2024-02-01 | Warnings | L7T10EIP3A |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 104f5b07-eed2-566c-e063-6294a90a6505 | 2024-02-01 | Warnings | L7T10EIP3A |
| HAV EZ Penetrating Pain Relief | MENTHOL | PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC | 70006efc-9cc8-4490-b28c-fcb23b1737c4 | 2024-02-01 | Warnings | L7T10EIP3A |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.