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 8 of 70 · 1,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
unii: PDC6A3C0OX
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
unii: PDC6A3C0OX
Natural Fluoride Fresh Mint cavity protection whitening fresh breathSODIUM FLUORIDETom's of Maine, Inc.fce5e8b5-34f8-4a45-a662-82c9034198092026-06-16WarningsExact identifier
unii: 8ZYQ1474W7
WALGREEN GLYCERIN ADULTGLYCERIN SUPPOSITORYWalgreens20c44346-0b29-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
unii: PDC6A3C0OX
WALGREENS GLYCERINGLYCERIN SUSPENSIONWalgreens20c44346-0b2b-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
unii: PDC6A3C0OX
PreviDent 5000 Enamel ProtectSODIUM FLUORIDE AND POTASSIUM NITRATEColgate Oral Pharmaceuticals, Inc.bbc66b1b-e05c-4e14-bef3-b8bae419fc892026-06-12Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent OrthoDefenseSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.99d37f3e-ac4f-4e8f-92e3-9b27d7632d352026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 392038
unii: 8ZYQ1474W7
Crest Plus Cinnamon plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company53fb780d-3e8b-6747-e063-6294a90a82112026-06-11WarningsExact identifier
unii: 8ZYQ1474W7
Colgate MaxClean with Whitening SmartfoamSODIUM FLUORIDEColgate-Palmolive Companyc712ae6b-eff3-4c54-b1fc-37304758d0592026-06-11WarningsExact identifier
unii: 8ZYQ1474W7
Equaline HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMUnited Natural Foods, Inc. dba UNFIbf87824a-522d-46da-81b6-e30ea11a22352026-06-11WarningsExact identifier
unii: PDC6A3C0OX
Toms Whole Care Mouthwash Fresh MintSODIUM FLUORIDETom's of Maine, Inc.6875f5c1-853c-43da-8226-c09a5518f9bb2026-06-10WarningsExact identifier
unii: 8ZYQ1474W7
PreviDent 5000 Dry MouthSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.d93ee76f-454b-40bf-9357-39a2ae3b6ccb2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 392038
unii: 8ZYQ1474W7
PreviDent 5000 KidsSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.29a110f3-f407-fdfa-4346-937269ca849b2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 392038
unii: 8ZYQ1474W7
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.df182c22-bbf1-448d-81e8-35cb431d2afc2026-06-08WarningsExact identifier
unii: 8ZYQ1474W7
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
unii: PDC6A3C0OX
PEROXICARESODIUM FLUORIDEChurch & Dwight Co., Inc.55262538-15ce-455c-93b1-bb02b5f81d6b2026-06-07WarningsExact identifier
unii: 8ZYQ1474W7
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: PDC6A3C0OX
3ECARE Dual FormulaWhiteningToothpasteSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.533fb7dd-7f84-59c5-e063-6394a90accad2026-06-02WarningsExact identifier
unii: 8ZYQ1474W7
Hello Unicorn Splash unicorn splash anticavity fluoride rinseSODIUM FLUORIDEColgate-Palmolive Companya1014431-7d23-aaff-6dc7-ab58683d03382026-06-02WarningsExact identifier
unii: 8ZYQ1474W7
Therabreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.feab3d45-ff95-4b32-8258-7d932a7380c92026-06-01WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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