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 |
|---|---|---|---|---|---|---|
| Childrens Mucus and Cough Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | Family Dollar Services, Inc. | 07ad76cc-2a6c-4a88-a5e9-5e8f6d1319e3 | 2024-04-17 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | f9530d55-8226-4659-84f0-2c0b411572be | 2024-04-17 | Warnings | 9D2RTI9KYH |
| MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG | RITE AID | c92dbbbb-d149-1e7e-e053-2a95a90a6f1a | 2024-04-17 | Warnings | 9D2RTI9KYH |
| MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MG | RITE AID | c9323799-3505-d6c1-e053-2995a90a6f43 | 2024-04-17 | Warnings | 9D2RTI9KYH |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | fac8b01a-9666-43cc-a4ff-3f3ed452c7e4 | 2024-04-17 | Warnings | 9D2RTI9KYH |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | P & L Development, LLC | 2af496a1-6fdd-4acf-9944-8b7cdf302275 | 2024-04-15 | Warnings | 9D2RTI9KYH |
| Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | 78ef7ad3-451d-43d0-a9b6-5cf0aadca003 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8fc8d87a-3951-4ac5-97df-c161ffc90475 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Equate Mucus Relief | GUAIFENESIN | Wal-Mart Stores, Inc. | 516c76ac-5e2d-41f9-81bd-20e05f0b2300 | 2024-04-09 | Warnings | 495W7451VQ |
| Daytime Cold and Flu Non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 9b0648ac-0ce3-4eaa-8977-26ae864f034d | 2024-04-09 | Warnings | 9D2RTI9KYH |
| Robitussin 12 Hour Cough Relief | DEXTROMETHORPHAN POLISTIREX | Haleon US Holdings LLC | 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5 | 2024-04-08 | Warnings | 9D2RTI9KYH |
| ROBITUSSIN COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 4908b326-e1da-44ca-8087-7e41a16c27b0 | 2024-04-08 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Childrens Robitussin 12 Hour Cough Relief | DEXTROMETHORPHAN POLISTIREX | Haleon US Holdings LLC | 6bcad434-5714-443c-ba83-ed534df9f20a | 2024-04-08 | Warnings | 9D2RTI9KYH |
| Mucus Relief Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN | H E B | 9ba5ca1b-2e3c-439e-8887-c26f144b88ef | 2024-04-08 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | 12ace982-bd47-49b0-ba1b-e0a29d42f1d6 | 2024-04-08 | Warnings | 9D2RTI9KYH |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | bd19b1f2-d9d3-4dab-8181-605f769ab62f | 2024-04-08 | Warnings | 9D2RTI9KYH |
| Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | 9f533092-060c-4379-9a77-ecfea8aa46e1 | 2024-04-08 | Warnings | 9D2RTI9KYH |
| Robitussin Maximum Strength 12 Hour Cough and Mucus Relief | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Haleon US Holdings LLC | 96409b52-b0ec-444b-bc39-fd41070e9855 | 2024-04-07 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Robitussin Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 66360295-f364-479a-8b49-c12b21918279 | 2024-04-06 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Robitussin Peak Cold Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 8c0a2424-e8ac-d91c-b46d-a5ee29f91936 | 2024-04-06 | Warnings | 9D2RTI9KYH 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.