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 235 of 236 · 4,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefGUAIFENESIN 400 MGAdvance Pharmaceutical Inc.5b78bbe9-806c-443f-bc23-351e5342355f2017-10-30WarningsExact identifier
unii: 495W7451VQ
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dollar General Medicated Pain Relief PatchCAMPHOR, MENTHOL, METHYL SALICYLATEDOLGENCORP, LLC86b0bd7b-c31c-4c35-a5da-0deac9558abe2017-10-01WarningsExact identifier
unii: L7T10EIP3A
NightTime Cold and FluACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINEVelocity Pharma516fc924-61f0-40ee-9688-3c6da817b4622017-09-11WarningsExact identifier
unii: 9D2RTI9KYH
Walgreens Adult Nighttime Wal Tussin DM Max Maximum StrengthDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWALGREEN CO.385a1e0b-09c5-4f2d-8404-086020e5c8912017-09-07WarningsExact identifier
unii: 9D2RTI9KYH
maximum strength mucus relief severe congestion and coughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESuperValu Inc.,3bb76952-15d8-4a36-a392-60f62b845f092017-09-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLSUPERVALU INCbe535a56-1b95-424e-8197-566976ef2efa2017-09-01Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.24fdad60-490d-6dc5-e054-00144ff8d46c2017-08-31WarningsExact identifier
unii: L7T10EIP3A
BRONCOCHEM KIDS ALLERGY CONTROLCHLORPHENIRAMINE MALEATE-DEXTROMETHROPHAN HBRLABORATORIO MAGANCEHM INTERNATIONAL SRL36574266-a6ca-443d-9e1d-85240aabe8a22017-04-10WarningsExact identifier
unii: 9D2RTI9KYH
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL523561fb-f6a7-4cde-9be2-bba02e60e2082017-04-06WarningsExact identifier
unii: 495W7451VQ
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Studio 35 External Analgesic Medicated BodyMENTHOL AND ZINC OXIDEWalgreen Co2dd63063-45c1-4029-99ac-0962a27a5ddc2017-02-08WarningsExact identifier
unii: L7T10EIP3A
CVS Sore Muscle Rub Vanishing ScentMENTHOLCVS Pharmacy454bbde9-3076-6977-e054-00144ff88e882017-01-04WarningsExact identifier
unii: L7T10EIP3A
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLd0426469-9dd1-4bd1-b81e-69d33187daa22016-12-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL8aa32b2a-a8be-4f8d-9b1f-eb007bff8e652016-12-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Professional Therapy MuscleCare TurboMENTHOL, CAMPHORActive and Innovative Inc.42f1e14a-3ac6-01c1-e054-00144ff8d46c2016-12-05WarningsExact identifier
unii: L7T10EIP3A
Dr. BlueMENTHOLIndiana Botanic Gardens1b1150bd-e087-4d8f-b0d6-0d935cf6e31e2016-11-01WarningsExact identifier
unii: L7T10EIP3A
Professional Therapy MuscleCareCAMPHOR, MENTHOLActive and Innovative Inc.1ec95bbb-cd7d-2588-e054-00144ff8d46c2016-08-11WarningsExact identifier
unii: L7T10EIP3A
Professional Therapy MuscleCare pain relieving gel Extra StrengthCAMPHOR, MENTHOLActive and Innovative Inc.1d2403d9-99c3-24f5-e054-00144ff8d46c2016-08-10WarningsExact identifier
unii: L7T10EIP3A
MED AID CHEST RUBMENTHOL AND CAMPHOR AND EUCALYPTUS OILBlue Cross Laboratories, Inc.429041fe-55a5-4df1-b60d-721103e5c65e2016-07-27WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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