FDA.reportPublic FDA data

NDC 70518-4559-01 - Metaxalone

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
70518-4559
Requested NDC
70518-4559-01
Package NDCs from labels
70518-4559-0, 70518-4559-1, 70518-4559-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metaxalone - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4559-0Metaxalone90 in 1 BOTTLE, PLASTICTABLET901

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 2 of 10 · 184 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
MetaxaloneMETAXALONEPreferred Pharmaceuticals, Inc.1541da6a-7681-40bc-b67e-28e02a950d722026-06-17Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEPreferred Pharmaceuticals Inc.8aa84e64-0075-4f22-a576-da085f32d56c2026-06-17Warnings, Adverse reactionsExact identifier
application number: ANDA207466
rxcui: 351254
unii: 1NMA9J598Y
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MetaxaloneMETAXALONESt. Mary's Medical Park Pharmacy5de36266-3964-5aca-e053-2991aa0a22052026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
MetaxaloneMETAXALONEDirect_Rx8c3bc0a2-5c93-e1d6-e053-2995a90a0b832026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
METAXALONEMETAXALONEDIRECT RX9b7b4fc3-3f38-db66-e053-2995a90aaadb2026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEDirect_Rx91432cd0-8404-8029-e053-2a95a90adc1b2026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONESt. Mary's Medical Park Pharmacya23ca660-b066-1396-e053-2a95a90a30b22026-05-05Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
MetaxaloneMETAXALONEHighmark Pharma LLC834be129-cfb5-4420-b660-025833376b3e2026-04-29Warnings, Adverse reactionsExact identifier
application number: ANDA207466
rxcui: 197935
unii: 1NMA9J598Y
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
MetaxaloneMETAXALONEAsclemed USA, Inc.f4a0e910-2b20-46d4-b49e-21fb15925b582026-04-17Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y

Reported adverse events (FAERS/openFDA)#

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