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 151 of 240 · 4,800 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCbdee2b65-2759-0e62-e053-2a95a90a03782025-04-07WarningsExact identifier
unii: L7T10EIP3A
RockSauce ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbdc7c7f3-ac98-8fe9-e053-2a95a90a26632025-04-07WarningsExact identifier
unii: L7T10EIP3A
RockSauce ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbd4fdff1-9174-31c2-e053-2a95a90a749f2025-04-07WarningsExact identifier
unii: L7T10EIP3A
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebc1c6-93fb-efd6-e053-2995a90a25bb2025-04-07WarningsExact identifier
unii: L7T10EIP3A
CBD Clinic Pain Relief - Level 4MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0e9ac7c-a840-2e05-e053-2a95a90a33f12025-04-07WarningsExact identifier
unii: L7T10EIP3A
CBDMEDIC Active Sport Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec5f47-2f8e-0558-e053-2a95a90aa7ca2025-04-07WarningsExact identifier
unii: L7T10EIP3A
MouthwashMENTHOL, METHYL SALICYLATE, THYMOLOrazen Inc873c43df-1d46-359b-e053-2a91aa0a43192025-04-07WarningsExact identifier
unii: L7T10EIP3A
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLC02d2a5a6-36bb-45b5-aba7-779615b276ed2025-04-05WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Nighttime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELSWALGREENS2be0a699-e6ad-ef56-e063-6394a90aaca52025-04-03WarningsExact identifier
unii: 9D2RTI9KYH
Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED44fb27d3-5125-4511-84d2-76555bc46e662025-04-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Hot Cold Medicated PatchesHOT COLD MEDICATED PATCHESHenan Enokon Medical Instrument Co., Ltd.159266a8-94fa-e2ff-e063-6394a90a9a772025-04-02WarningsExact identifier
unii: L7T10EIP3A
Pain Relief PatchPAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.1592d29d-e275-a44d-e063-6294a90ab17d2025-04-02WarningsExact identifier
unii: L7T10EIP3A
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
dextromethorphan polistirex extended releaseDEXTROMETHORPHAN POLISTIREXBryant Ranch Prepackbd415342-90e1-411b-b6c9-652e9532c6112025-04-02WarningsExact identifier
unii: 9D2RTI9KYH
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION31b8ad0a-3637-03db-e063-6394a90acdc32025-04-01WarningsExact identifier
unii: 495W7451VQ
CVS Pain ReliefMENTHOL 10.5%CVSd0ea80ce-38b2-acde-e053-2995a90a47e52025-03-31WarningsExact identifier
unii: L7T10EIP3A
Pharmacys Prescription Vapor RubMENTHOLAmerican Consumer Products Corp31aa54d8-df8d-f1ae-e063-6294a90a96222025-03-31WarningsExact identifier
unii: L7T10EIP3A
GuaifenesinGUAIFENESINBryant Ranch Prepack570a71eb-2d19-4c7b-8c00-e1524bfa38442025-03-31WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION365c01b7-a197-4876-85fc-42204f787e3a2025-03-28WarningsExact identifier
unii: 495W7451VQ
Zpol ULTRAMENTHOL, METHYL SALICYLATELaboratorios Zepol S.A.1a1433a6-8d04-96df-e063-6394a90a987b2025-03-27WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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