FDA.reportPublic FDA data

NDC 57511-0504-01 - FluoriMax 5000

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
57511-0504
Requested NDC
57511-0504-01
Package NDCs from labels
57511-0504-1, 57511-0504-2, 57511-0504-01
Manufacturer
Elevate Oral Care
Effective date
2025-09-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FluoriMax 5000 - Elevate Oral CareElevate Oral Care2025-09-19HUMAN PRESCRIPTION DRUG LABEL
FluoriMax 5000 - Elevate Oral CareElevate Oral Care2020-09-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0504-1FluoriMax 500096 g in 1 TUBEPASTE, DENTIFRICE962
57511-0504-2FluoriMax 50002 in 1 BOXPASTE, DENTIFRICE22
57511-0504-1FluoriMax 500096 g in 1 TUBEPASTE, DENTIFRICE961

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57511-0504FLUORIMAX 5000 (1.1% SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [ELEVATE ORAL CARE]1Current NDC, Legacy NDC, 2 package rows20220615_d9e462d9-f0fd-4168-e053-2995a90a95b2.zip
57511-0504FLUORIMAX 5000 (1.1% SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [ELEVATE ORAL CARE]1Current NDC, Legacy NDC, 1 package rows20200902_ae45ae2d-a21f-0a05-e053-2995a90a4d5e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57511-0504-1GM - Gram57511-050436551a61-0e2f-4ef3-9b28-c46ce348f51012023-08-08

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 70 · 1,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
unii: 8ZYQ1474W7
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited98315c6e-308d-423b-a046-4be1f54d30ae2026-09-01Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited125121b8-bc4c-44ee-906e-e72f652a5aa62026-09-01Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
unii: 8ZYQ1474W7
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
unii: 8ZYQ1474W7
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Kids Flouride RinseSODIUM FLUORIDEYour Military Exchanges5f6f4125-6264-4724-bb7e-a6e100939b412026-08-28Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Colgate MaxFresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-26WarningsExact identifier
unii: 8ZYQ1474W7
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company59dff762-7f66-8bdc-e063-6294a90a9f182026-08-25WarningsExact identifier
unii: 8ZYQ1474W7
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
unii: 8ZYQ1474W7
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
unii: 8ZYQ1474W7
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
unii: 8ZYQ1474W7
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
unii: 8ZYQ1474W7
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
unii: 8ZYQ1474W7
SprinJene White BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp8c401bea-0148-46a0-bbb3-80c17f9e8e3e2026-08-14WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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