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 |
|---|---|---|---|---|---|---|
| Maximum Strength Cold Sore Treatment | CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM | Meijer Distribution Inc | 9220772c-b3b7-4855-e053-2a95a90a94f6 | 2024-11-27 | Warnings | L7T10EIP3A |
| Severe Sinus Congestion Allergy and Cough Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | 36a4ec1f-50c3-4d61-ada9-987ccad3563c | 2024-11-26 | Warnings | 9D2RTI9KYH |
| Orajel Cold Sore Moisturelock | BENZOCAINE | Church & Dwight Co., Inc. | 3761c7b3-053b-0f50-e054-00144ff88e88 | 2024-11-26 | Warnings | L7T10EIP3A |
| PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3% | PURIFIED WATER 98.3% | Acme United Corporation | 9248ee71-2d47-620d-e053-2995a90af5c8 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | cca454e0-b2bd-4215-bc06-426fcc3f7bd6 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | d3812fa3-9334-464d-b50c-98548ff76727 | 2024-11-26 | Warnings | 059QF0KO0R |
| DANGTTEOL | MINERAL WATER | AQBC CO., LTD | 27db14a9-3812-433f-e063-6394a90a11e7 | 2024-11-26 | Warnings | 059QF0KO0R |
| BRONCOCHEM COLD AND FLU CAPLETS | ACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6 | 2024-11-26 | Warnings | 9D2RTI9KYH |
| Alka-Seltzer Plus Cold and Flu, CVP | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET | Lil' Drug Store Products, Inc. | e7a27773-69d6-9e07-e053-2a95a90af8ea | 2024-11-25 | Warnings | 9D2RTI9KYH |
| Night Cold Flu Cough and Allergy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0 | 2024-11-25 | Warnings | 9D2RTI9KYH |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | cbd3a905-1c41-4cb0-8df6-36784430d627 | 2024-11-25 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 7a28d0fe-0e0a-453a-b604-1cc784dd153c | 2024-11-25 | Warnings | 9D2RTI9KYH |
| Cough and Cold plus | ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | c483d88f-cb0a-4dd6-b3ae-559521782ba6 | 2024-11-25 | Warnings | 9D2RTI9KYH |
| DayTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 3af20739-6794-42e0-b404-3f0401d10a6d | 2024-11-25 | Warnings | 9D2RTI9KYH |
| Dextromethorphan HBr 15 mg | DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. | ffc7e1e2-b664-461b-963d-764bad2f983f | 2024-11-25 | Warnings | 9D2RTI9KYH |
| 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 495W7451VQ |
| 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 |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.