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 232 of 236 · 4,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care childrens cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC5b7c2306-ad87-48b0-99b7-71427907db0c2021-03-23WarningsExact identifier
unii: 9D2RTI9KYH
basic care cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLCa0f35883-9dd3-49e7-87ac-ce04561ad6c32021-03-09WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGTopCo Associates, LLC7d91c6ab-d161-42b9-b353-0aa8f59619f82021-01-21WarningsExact identifier
unii: 495W7451VQ
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEProficient Rx LPed9399e2-2be8-4793-99c5-204779c2a4712021-01-01Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
MucinexGUAIFENESINProficient Rx LPf3ade814-2759-4ad0-a196-210e84d8cde92021-01-01WarningsExact identifier
unii: 495W7451VQ
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGAllegiant Healthbed5f9dc-45ea-4e90-86c6-86599b6f38612020-11-16WarningsExact identifier
unii: 9D2RTI9KYH
Nighttime Cold and Flu ReliefACETAMINOPHENAllegiant Healthb97126d7-847d-483e-b3d1-e2b61ab1743f2020-11-11WarningsExact identifier
unii: 9D2RTI9KYH
JEGAMSAN ExtractLONICERA FLOWER, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROMIDEI World Pharmaceutical Co., Ltd.af695c7e-1ad2-ad98-e053-2995a90a2edf2020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
SoCheongRyong Tang ExtractGINGER, CHLORHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af68634f-eb0a-64e7-e053-2a95a90a5df22020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
PEDOXAN ExtractCITRUS UNSHIU PEEL, SAPOSHNIKOVIA ROOT, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af69d604-180c-702f-e053-2a95a90a2ae42020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
equate cough dmDEXTROMETHORPHAN POLISTIREXWal-Mart Stores Inc5f72c4ad-1c30-41ea-b39c-7f4bb3deced62020-07-08WarningsExact identifier
unii: 9D2RTI9KYH
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.ee831456-5962-4d5e-ad0c-69ab858604532020-06-03Exact identifier
unii: XF417D3PSL
Cough DMDEXTROMETHORPHAN POLISTIREXCVS Pharmacy956f0bd4-3266-4754-9bd2-ac480e3bcbce2020-05-27WarningsExact identifier
unii: 9D2RTI9KYH
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RenacidinCITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATEUnited-Guardian, Inc.13a9bbba-db21-4cba-991c-5d8afaf2ed742019-12-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
CareOne Cough DMDEXTROMETHORPHAN POLISTIREXAmerican Sales Company42f67a3c-8cd7-44a6-8e54-08fb8449e8d72019-12-09WarningsExact identifier
unii: 9D2RTI9KYH
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.e41adb4e-06fb-4141-ba55-50b043f3c9da2019-11-19Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.14445dfd-6041-40cd-a043-3f4da6bcb9c12019-11-18Exact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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