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 170 of 240 · 4,790 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Hot MedicatedMENTHOLThe Mentholatum Company85bf425d-59d7-4462-ba46-2921454600992024-12-13WarningsExact identifier
unii: L7T10EIP3A
Mentholatum Lidocaine IceLIDOCAINE HCL, MENTHOLThe Mentholatum Company4d74cbab-31cd-4579-9360-6852ee215b5e2024-12-13WarningsExact identifier
unii: L7T10EIP3A
Mentholatum Deep Heating Rub Extra StrengthMENTHOL, METHYL SALICYLATEThe Mentholatum Companyf5684158-0d83-4031-b493-5422ddc73e782024-12-13WarningsExact identifier
unii: L7T10EIP3A
Mentholatum Lavender Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company6f208c05-617d-492a-a016-e9d6be3c971f2024-12-13WarningsExact identifier
unii: L7T10EIP3A
Discount Drug Mart Anti-ItchCAMPHOR, MENTHOLDiscount Drug Mart87d379da-103a-c751-e053-2995a90a56de2024-12-13WarningsExact identifier
unii: L7T10EIP3A
Household DetoxALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLONDeseret Biologicals, Inc.7f79058a-c35a-429a-be3c-4cff1d6570872024-12-13WarningsExact identifier
unii: A2I8C7HI9T
Kroger Daytime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Companye428dd83-c538-2a92-e053-2a95a90a0e162024-12-13WarningsExact identifier
unii: 9D2RTI9KYH
Kroger Nighttime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Companye46291c7-6f4d-46a2-e053-2a95a90a80a12024-12-13WarningsExact identifier
unii: 9D2RTI9KYH
Salonpas Arthritis PainMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.a6518167-fe32-43b2-b736-ba01ac69c12d2024-12-13WarningsExact identifier
unii: L7T10EIP3A
HealthWise Medicated Foot PowderMENTHOLVeridian Healthcare2916a0c3-2d66-d079-e063-6394a90acd6b2024-12-12WarningsExact identifier
unii: L7T10EIP3A
Ease Your PainMENTHOLProximity Capital Partners LLC dba Asutra83366ae1-e1d9-2a30-e053-2a91aa0a1cc42024-12-12WarningsExact identifier
unii: L7T10EIP3A
Topcare mucus erGUAIFENESINTopco Associates LLCe3c900ad-21b1-4cd0-8c48-f54f115df4032024-12-12WarningsExact identifier
unii: 495W7451VQ
Walgreens Cool and HeatMENTHOL 16%Walgreensce1585f4-ca65-8d0c-e053-2995a90a8e892024-12-11WarningsExact identifier
unii: L7T10EIP3A
Walgreens Cool n HeatLIDOCAINE 4%Walgreensce1b21d6-7aa6-2b18-e053-2995a90a4c912024-12-11WarningsExact identifier
unii: L7T10EIP3A
Walgreens Pain Burn Itch ReliefBENZOCAINE 20%, MENTHOL 0.5%Walgreenscc6e4b42-fdd8-6ff7-e053-2995a90a3d1d2024-12-11WarningsExact identifier
unii: L7T10EIP3A
CVS Pain ReliefMENTHOL 4%CVSd1660d55-1ee0-7aa2-e053-2995a90a65792024-12-11WarningsExact identifier
unii: L7T10EIP3A
CVS Muscle RubMENTHOL 10%, METHYL SALICYLATE 15%CVS Healthc72c9a95-4226-6d69-e053-2a95a90a8e1c2024-12-11WarningsExact identifier
unii: L7T10EIP3A
BENGAY ULTRA STRENGTH NON-GREASYCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEKenvue Brands LLC0a41ec65-bd0b-4fc6-807d-74f353341cc72024-12-11WarningsExact identifier
unii: L7T10EIP3A
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
unii: XF417D3PSL
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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