FDA.reportPublic FDA data

NDC 57237-312-05 - 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
57237-312
Requested NDC
57237-312-05
Package NDCs from labels
57237-312-05, 57237-312-51
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
57237-312-05Dextromethorphan HBr. and Guaifenesin5 mL in 1 CUP, UNIT-DOSESOLUTION55
57237-312-51Dextromethorphan HBr. and Guaifenesin100 in 1 BOX, UNIT-DOSESOLUTION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-312DEXTROMETHORPHAN 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
57237-312-05ML - Milliliter57237-312b4445953-07cc-4aef-bec3-b0d9427f679812023-07-06
57237-312-51ML - Milliliter57237-312474f4a31-90f7-44ca-8151-f945ba6b798712023-07-06

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 106 of 240 · 4,800 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens ChildrensNIGHTTIME COUGHWALGREENS CO.a270cbe3-bf0a-44da-9359-00e218eba2392025-12-01WarningsExact identifier
unii: 9D2RTI9KYH
Adult Cough plus Chest Congestion DM with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINWALGREEN COMPANY5f5af13a-c2a3-4bbe-880e-9c57b36e92342025-12-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Walgreens Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWALGREEN COMPANYb2e08f4d-9753-4767-a8eb-3740dd1034cc2025-12-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
WALGREENS Cold Cough and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.1e903034-942e-4c6e-9f96-eb097c2665802025-12-01WarningsExact identifier
unii: 9D2RTI9KYH
CareAll Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUSNew World Imports, Inc4cd2f751-e072-4f4e-b059-ed1dfcc60c6b2025-12-01WarningsExact identifier
unii: L7T10EIP3A
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Inccba7c084-379f-4a16-aeba-b11ca6e20d8a2025-12-01WarningsExact identifier
unii: L7T10EIP3A
CAREALL Musle and JointMENTHOLNew World Imports, Inc013beea4-b2c2-4e84-b4cb-3125ac48e8c02025-12-01WarningsExact identifier
unii: L7T10EIP3A
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY, INCbbb1b395-48d9-4859-ad52-6650961089d92025-12-01WarningsExact identifier
unii: 9D2RTI9KYH
Members Mark Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRSAM'S WEST INC2b59f90b-b8fc-03c0-3527-a8efa97fbfe32025-11-30WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRDr. Reddy's Laboratories Inc.5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2025-11-30WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 1200 mgGUAIFENESINYYBA CORPd9d2539b-bd31-66bd-e053-2a95a90aa5832025-11-27WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgGUAIFENESINYYBA CORPd9d1ce2d-d96a-4950-e053-2995a90ad9882025-11-27WarningsExact identifier
unii: 495W7451VQ
Severe Sinus Pain and CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfbc541ac-9465-4296-bb1e-811b9d811f402025-11-26WarningsExact identifier
unii: 495W7451VQ
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLWALGREENS CO.bfc58cd5-9815-43af-895d-ec6cbd10937e2025-11-26WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Walgreen Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY40c038a3-91c7-4ed0-8210-65d58b82ca2b2025-11-26WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINWALGREENS CO724554ab-60b8-46c8-96a8-a98242604e3b2025-11-26WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Walgreens Grape FlavorCHILDREN COUGH AND CHEST CONGESTIONWALGREENS795cf1af-3847-46bc-b605-64a38e57cca22025-11-26WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
WalgreensCHILDRENS STUFFY NOSE AND COLDWALGREENS CO.7ac3de2d-1d10-49ec-a2da-da46977684ad2025-11-26WarningsExact identifier
unii: 495W7451VQ
Childrens Chest Congestion ReliefGUAIFENESINWALGREENS COMPANYc1382512-e6f3-4bdf-a9e6-4f68dd5ea5532025-11-26WarningsExact identifier
unii: 495W7451VQ
WALGREEN ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY02ad9f98-07ad-4786-a1ab-169b870fec012025-11-26WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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