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 216 of 236 · 4,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINAurohealth LLC84117b6e-4eeb-42b0-90b1-331f70d5a1752023-12-01WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINRITE AID CORPORATIONde16ec42-4a31-4b18-e053-2995a90a78a42023-12-01WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Expectorant and Cough Suppressant Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HBRWinco Foods, LLC.ac1c8633-4064-4e2f-9b43-4ae9bdd1a4272023-12-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAhold U.S.A., Inc,e9add770-58e0-4cf3-bbc2-d293ca870b032023-12-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLKROGER COMPANYb97aeb2c-07ac-d00e-e053-2a95a90abf402023-12-01WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLCa1921611-343c-4c2a-846d-c8de19dddab52023-12-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLWALGREEN CO.cc1ac1b4-cbc4-539c-e053-2a95a90a5b752023-12-01WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Expectorant and Cough SuppressantGUAIFENESIN AND DEXTROMETHORPHAN HBRWinco Foods, LLC.e7e16bab-a7aa-4911-9a29-0c986b26da672023-12-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP2adf3c4d-636f-4e02-b501-946b4df5f5d62023-12-01WarningsExact identifier
unii: L7T10EIP3A
LidozenLIDOCAINE, MENTHOLProficient Rx LP488d665c-a4fe-4a69-bab3-34b2347f4b052023-12-01WarningsExact identifier
unii: L7T10EIP3A
Thera Plus Cool and Heat Pain Relieving Gel MentholMENTHOLFourstar Group USA, Inc.0a225714-ccb1-4676-e063-6294a90aeeb22023-11-30WarningsExact identifier
unii: L7T10EIP3A
Ice QuakeMENTHOLSouthern Sales & Service, Inc.7a05832f-49ac-4013-b240-4405501e45cd2023-11-29WarningsExact identifier
unii: L7T10EIP3A
ICE MUSCLE RUB Leon M.CMENTHOLSouthern Sales & Service, Inc.4efaf347-7406-4690-8005-e7cf2e3d42222023-11-29WarningsExact identifier
unii: L7T10EIP3A
IceQuake Analgestic WhiteMETHYL SALICYLATE, MENTHOLSouthern Sales & Service, Inc.54e5dcd5-9987-488d-a758-d0e76d1551822023-11-29WarningsExact identifier
unii: L7T10EIP3A
Icequake Coldn Hot medicated patchMENTHOLSouthern Sales & Service, Inc.89202c52-9eb7-4e5a-a709-4a66ab0d3a722023-11-29WarningsExact identifier
unii: L7T10EIP3A
AkinGUAIFENESINSouthern Sales & Service, Inc.bb2c9f21-6765-4286-bd71-de01cdf4c4e92023-11-29WarningsExact identifier
unii: 495W7451VQ
Akin Cough Formula DMDEXTROMETHORPHAN, GUAIFENESINSouthern Sales & Service, Inc.1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a2023-11-29WarningsExact identifier
rxcui: 996520
unii: 9D2RTI9KYH
unii: 495W7451VQ
Ice Quake Muscle Rub BlueMENTHOLSouthern Sales & Service, Inc.5180f6a3-58f1-4c50-a33b-7d85a3c1b99b2023-11-29WarningsExact identifier
unii: L7T10EIP3A
SIMPEX GuaifenesinGUAIFENESINSimpex Pharma Pvt. Ltd1594f9d6-0c48-42bf-b76b-d621f215179a2023-11-29WarningsExact identifier
unii: 495W7451VQ
Herbal Utaplas External Analgesic PlasterMENTHOL, METHYL SALICYLATEBig 5 Nutrition LLCaeaf070f-4512-4b8f-9bd8-960f6bb828812023-11-28WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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