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 32 of 243 · 4,855 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6bef9ccb-7a5a-4c67-b1bc-a92b167312da2026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Roll-OnMENTHOLReckitt Benckiser LLCebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb2026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Precision Relief PenMENTHOLReckitt Benckiser LLCb4cc1db5-a33f-17bc-e053-2995a90ab7eb2026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Professional Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCf62f8ec3-593d-480a-85a0-01fcd7f1790c2026-05-15WarningsExact identifier
unii: L7T10EIP3A
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ONMENTHOLReckitt Benckiser LLC8af185ad-719e-4684-89c0-9c17c12774992026-05-15WarningsExact identifier
unii: L7T10EIP3A
PERFORM COOL and SOOTHING PAIN RELIEVINGMENTHOLReckitt Benckiser LLCef158f63-2d75-47a3-b94a-2d821d5118632026-05-15WarningsExact identifier
unii: L7T10EIP3A
Sinus Congestion and Pain Relief Non-Drowsy/DaytimeACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLRite Aid Corporation38d73a1e-ac78-4f67-9291-bb48ab80306e2026-05-15WarningsExact identifier
unii: 495W7451VQ
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRWALMART INC.071615ba-f50a-4d2a-a358-43140bccce722026-05-14WarningsExact identifier
unii: 9D2RTI9KYH
Plantar Pain Relief PatchLIDOCAINE AND MENTHOLGuangzhou Sumi Technology Innovation Co., Ltd4e8734db-e474-e1fa-e063-6394a90a30292026-05-14WarningsExact identifier
unii: L7T10EIP3A
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLCardinal Health, 110 dba LEADER77066d01-75b0-4a8d-88d3-c639626d33262026-05-14WarningsExact identifier
unii: L7T10EIP3A
Pain ReliefLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.3ed51136-ea8e-8101-e063-6394a90acd4c2026-05-14WarningsExact identifier
unii: L7T10EIP3A
PAIN RELIEF Gel-PatchLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.4fdae0ab-94ba-5707-e063-6294a90a1f9d2026-05-14WarningsExact identifier
unii: L7T10EIP3A
OVERNIGHT RELIEF Gel-PatchMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.2c6c4737-dff3-6382-e063-6294a90a412c2026-05-14WarningsExact identifier
unii: L7T10EIP3A
Pain ReliefMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.3ed34e65-9d74-daff-e063-6394a90a94c72026-05-14WarningsExact identifier
unii: L7T10EIP3A
MENTHOL PAIN RELIEF Gel-PatchMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.0e6a09cc-7986-f851-e063-6294a90aff672026-05-14WarningsExact identifier
unii: L7T10EIP3A
PAIN RELIEF Gel-PatchLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.3c166165-2ad8-206f-e063-6294a90a52fc2026-05-14WarningsExact identifier
unii: L7T10EIP3A
OVERNIGHT RELIEF Gel-PatchMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f1041b25-eb09-e43d-e053-2995a90a073a2026-05-14WarningsExact identifier
unii: L7T10EIP3A
PAIN RELIEF Gel-PatchLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f1047707-3fe5-06bc-e053-2995a90a59b92026-05-14WarningsExact identifier
unii: L7T10EIP3A
Elastic Relief StripMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f103cf8a-a285-28d1-e053-2995a90ae70e2026-05-14WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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