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 154 of 240 · 4,800 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arctic Blast Pain ReleivingMENTHOL, CAMPHOR (SYNTHETIC)Nutriomo Labs Pte, Ltdd5e7d26d-4f63-4b7b-a173-fe3a794c84592025-03-10WarningsExact identifier
unii: L7T10EIP3A
HISTEX-DM New FormulationDEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCIAllegis Pharmaceuticals, LLC30010401-e5b4-2bd9-e063-6394a90a0b0b2025-03-10WarningsExact identifier
unii: 9D2RTI9KYH
Eagle Brand Medicated Plaster Extra StrengthMENTHOL, CAPSAICINBorden Company (Private) Limited2f2a4080-d538-1c6a-e063-6394a90ae51c2025-03-10WarningsExact identifier
unii: L7T10EIP3A
Leader Mucus ReliefGUAIFENESINCardinal Health 110, LLC. dba Leader34981e01-f405-4feb-807b-3a8c02faca962025-03-09WarningsExact identifier
unii: 495W7451VQ
daytime severe cold multi-symptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcc7c5f1c-76b7-4278-8e2a-5fbc85e022dd2025-03-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Cold and Head Congestion Relief SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLCa39778ba-1f63-4495-8e9b-44b0bdd7f71a2025-03-08WarningsExact identifier
unii: 495W7451VQ
Extra Strength TYLENOL Severe Cough Plus Sore Throat DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC2e9540e4-bd1d-9370-e063-6294a90affcb2025-03-07WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief ERGUAIFENESINMajor Pharmaceuticalse5a242bf-3008-4c92-a930-e76f733be5cf2025-03-07WarningsExact identifier
unii: 495W7451VQ
Herbal Cough Drops Original HerbCOUGH DROPSTopco Associates LLC2fb22181-aee3-d0bf-e063-6294a90a78652025-03-06WarningsExact identifier
unii: L7T10EIP3A
Pain Relieving CreamCAMPHOR AND MENTHOLPAIN WIZARD LIMITED LIABILITY COMPANY1cd37b69-2cfb-130d-e063-6394a90af50b2025-03-06WarningsExact identifier
unii: L7T10EIP3A
REVASOL DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERnv LLC2f9ddcc3-b913-f8b0-e063-6294a90a93ab2025-03-05WarningsExact identifier
unii: 9D2RTI9KYH
Herbal Throat Drops Lemon Mint HerbTHROAT DROPSTopco Associates LLC2fa086b4-3b0e-0df8-e063-6294a90a67692025-03-05WarningsExact identifier
unii: L7T10EIP3A
Listerine Freshburst AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee1e1df9-74c6-d24b-e053-2a95a90a43d32025-03-04WarningsExact identifier
unii: L7T10EIP3A
CVS Daytime Cough Relief Chews - Citrus PunchDEXTROMETHORPHAN HBRCVS2f885f1b-7ff5-251b-e063-6394a90a656f2025-03-04WarningsExact identifier
unii: 9D2RTI9KYH
CVS Dex-Dox Kids Nighttime Cough SuppressantDEXTROMETHORPHAN HBRCVS2f8b6f5e-399c-b033-e063-6294a90ac3d12025-03-04WarningsExact identifier
unii: 9D2RTI9KYH
Menthol Pain Relief Gel PatchMENTHOL PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANYeab185d6-2a54-489d-8114-fe8088624ba42025-03-04WarningsExact identifier
unii: L7T10EIP3A
Peppermint soothing creamCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOLHenan Lijitang Medical Technology Co., Ltd.2f6bc332-3006-710d-e063-6394a90acea52025-03-03WarningsExact identifier
unii: L7T10EIP3A
Arthcal Soothing Pain Relief Massage GelEMU,ARNICABeijing JUNGE Technology Co., Ltd.2f6cb08e-64e2-cf05-e063-6294a90afc912025-03-03WarningsExact identifier
unii: L7T10EIP3A
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCedb9e374-4dba-5823-e053-2a95a90a3da52025-03-03WarningsExact identifier
unii: L7T10EIP3A
Hot and Cold Lidocaine with Menthol Patch Pain ReliefLIDOCAINE AND MENTHOLInterMed Laboratories Private Limited3f3a4912-27b7-4a49-8880-a9cc162c93b02025-03-01WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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