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 |
|---|---|---|---|---|---|---|
| Fast Freeze Pain Relieving Continuous | MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 998a4824-9ed9-4fe0-b45b-72e52861fcd3 | 2024-10-04 | Warnings | L7T10EIP3A |
| Fast Freeze | MENTHOL | Natural Essentials Inc. | a96e3e41-871c-4cf3-93b6-af2a6246ded8 | 2024-10-04 | Warnings | L7T10EIP3A |
| Bio Co-Enzyme Phase | CARDUUS MARIANUS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-, | Deseret Biologicals, Inc. | afad858e-064f-454d-be78-da1501ffe853 | 2024-10-04 | Warnings | XF417D3PSL |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Bryant Ranch Prepack | 4368822d-2779-4fb2-9ca9-f020b8934dc5 | 2024-10-04 | Warnings, Adverse reactions | 9D2RTI9KYH |
| Listerine Cool Mint Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Navajo Manufacturing Company Inc. | f5f26e2f-8a1f-4687-e053-2a95a90ae378 | 2024-10-03 | Warnings | L7T10EIP3A |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Navajo Manufacturing Company Inc. | f6068011-ad56-59b4-e053-2995a90ac016 | 2024-10-03 | Warnings | 9D2RTI9KYH |
| Gold Bond Medicated Original Strength Body | MENTHOL | Navajo Manufacturing Company Inc. | f71d598c-92c3-d6fd-e053-6394a90a97d7 | 2024-10-03 | Warnings | L7T10EIP3A |
| TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1 | ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE | Terumo Corporation | 39f2e11c-5a31-469f-b725-d096c1674421 | 2024-10-03 | Warnings | XF417D3PSL |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Aurohealth LLC | cc20129b-2556-4452-9222-afd503f1e7a4 | 2024-10-03 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Geliga Muscular | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | fb2beb08-0ad6-a89d-e053-6294a90aa6fe | 2024-10-02 | Warnings | L7T10EIP3A |
| Geliga Muscular Balm | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | da28097f-4b5c-6159-e053-2a95a90a7d96 | 2024-10-02 | Warnings | L7T10EIP3A |
| Eagle Medicated Aromatic | CAMPHOR MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | 36abfc2c-d424-4df8-968d-866342c96a56 | 2024-10-02 | Warnings | L7T10EIP3A |
| Eagle Balm | CAMPHOR MENTHOL | Eagle Indo Pharma, PT | 87614869-9675-2c76-e053-2a95a90a48a9 | 2024-10-02 | Warnings | L7T10EIP3A |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | d9a93daa-4e24-6690-e053-2a95a90a147c | 2024-10-02 | Warnings | L7T10EIP3A |
| Eagle Extra Strength | MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | 5e02fbe3-5bc7-430e-b661-3a760ddd8fe0 | 2024-10-02 | Warnings | L7T10EIP3A |
| Eagle Medicated Oil Refreshing | MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | c62a4313-2c07-5f58-e053-2995a90a083a | 2024-10-02 | Warnings | L7T10EIP3A |
| Eagle Medicated Aromatic | CAMPHOR MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | e272ec90-3cd9-5b70-e053-2a95a90a1df4 | 2024-10-02 | Warnings | L7T10EIP3A |
| Herb Street Backache and Sore Muscle Relief | MENTHOL | Balassa Laboratories Inc. | aeac1b64-8689-4b3d-a41c-db41061257b5 | 2024-10-01 | Warnings | L7T10EIP3A |
| Herb Street Arthritis Relief | MENTHOL/CAMPHOR | Balassa Laboratories Inc. | a9d8ceb7-def0-415f-8fc1-ff8dd3e41855 | 2024-10-01 | Warnings | L7T10EIP3A |
| Medicated Herbal Lip Balm | MENTHOL | Earth Mama Angel Baby LLC | 1cc2391e-6a7a-609c-e063-6394a90a6305 | 2024-10-01 | Warnings | L7T10EIP3A |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.