FDA.reportPublic FDA data

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 table
LabelManufacturerEffective dateType
Dextromethorphan HBr. and Guaifenesin - Rising Pharma Holdings, Inc.Rising Pharma Holdings, Inc.2026-09-22HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-313-01Dextromethorphan HBr. and Guaifenesin10 mL in 1 CUP, UNIT-DOSESOLUTION105
57237-313-18Dextromethorphan HBr. and Guaifenesin80 in 1 BOX, UNIT-DOSESOLUTION805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-313DEXTROMETHORPHAN HBR. AND GUAIFENESIN SOLUTION [RISING PHARMA HOLDINGS, INC.]4Current NDC, 2 package rows20241013_e463e60f-d0db-4ee7-9713-ddf25aa38a43.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-313-01ML - Milliliter57237-313b4b7f776-ef79-4ae7-91fd-645b4e7d702c12023-07-06
57237-313-18ML - Milliliter57237-3131a032e32-c5d7-44b4-8e28-95a98c950ff812023-07-06

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.

Matched openFDA labels page 137 of 241 · 4,817 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Pain Relief Gel Roll-OnLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd31639407-0f11-bde2-e063-6294a90af6942025-08-10WarningsExact identifier
unii: L7T10EIP3A
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANI Pharmaceuticals, Inc.a52e210f-b99d-493e-b679-ec565c6ff72d2025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Diabetic Tussin DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINMEDTECH PRODUCTS INCa10a3b33-7503-4334-8ed7-2bb881df43272025-08-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Arthcal SOOTHING PAIN RELIEF MASSAGESOOTHING PAIN RELIEF MASSAGEBeijing JUNGE Technology Co., Ltd.3524ad62-0ed6-f2e5-e063-6394a90a32832025-08-06WarningsExact identifier
unii: L7T10EIP3A
Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E Bb7434978-44a8-4c51-979d-0bc446461e432025-08-06WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Tussin DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacyfc1e224c-5c57-43fc-ae6e-36aa0a4ae4392025-08-06WarningsExact identifier
unii: 9D2RTI9KYH
Good Neighbor Roll-on Menthol Pain Relief GelMENTHOLAmerisource Bergenbd557323-0003-4ee6-b22d-a72d621c7de42025-08-05WarningsExact identifier
unii: L7T10EIP3A
Earthmed FS Pain relieving balmMENTHOLEarthmed LLC3ba4e769-fec6-52d9-e063-6394a90a65d42025-08-05WarningsExact identifier
unii: L7T10EIP3A
childrens cold cough dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPublix Super Markets Inc6efe7097-2a99-4654-9d94-b47f2e64d19d2025-08-05WarningsExact identifier
unii: 9D2RTI9KYH
THERASTATCHERRY COUGH DROPSHART Health96bae19a-3337-4199-9b8c-cdf9b368178b2025-08-04WarningsExact identifier
unii: L7T10EIP3A
mucus dm extended releaseGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDECVS Pharmacy6c9540ae-aea1-4717-8dca-60850ebdb1b42025-08-04WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief ERGUAIFENESINRugby Laboratories2e6901aa-16f6-9b73-e063-6294a90a4d722025-08-02WarningsExact identifier
unii: 495W7451VQ
Menthol pain relief patchesMENTHOLMenthol pain relief patch3b5fd718-3f86-f7a7-e063-6294a90a8c522025-08-02WarningsExact identifier
unii: L7T10EIP3A
Graphene Far Infrared Herbal Pain Relief PatchesCORYDALIS RHIZOMEChangsha Maocheng Trading Co., Ltd3b604a3c-fe91-7096-e063-6394a90afe042025-08-02WarningsExact identifier
unii: L7T10EIP3A
Active Recovery Pain ReliefCAMPHOR, MENTHOLCharlotte's Web, Inc.3a9f9ca0-3d8a-796a-e063-6394a90a790c2025-08-01WarningsExact identifier
unii: L7T10EIP3A
Active Recovery Pain Relief StickCAMPHOR, MENTHOLCharlottes Web, Inc.3aa037c6-6109-b52e-e063-6394a90a215b2025-08-01WarningsExact identifier
unii: L7T10EIP3A
PM Recovery Pain ReliefCAMPHOR, MENTHOLCharlotte's Web, Inc.3aa08859-809d-de8c-e063-6394a90a8e252025-08-01WarningsExact identifier
unii: L7T10EIP3A
Vaporizing chest rubCAMPHOR, EUCALYPTUS OIL, MENTHOLLJ Pharma065bb666-e482-4e96-ac75-c6577dcc5b482025-08-01WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.