FDA.reportPublic FDA data

NDC 57511-0002-01 - Just Right 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
57511-0002
Requested NDC
57511-0002-01
Package NDCs from labels
57511-0002-1, 57511-0002-01
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
Just Right 5000 - Elevate Oral CareElevate Oral Care2025-09-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0002-1Just Right 500097 g in 1 TUBEGEL, DENTIFRICE973

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57511-0002JUST RIGHT 5000 (1.1% SODIUM FLUORIDE TOOTHPASTE) GEL, DENTIFRICE [ELEVATE ORAL CARE]2Current NDC, Legacy NDC, 1 package rows20210209_adf0c686-e6a1-03f5-e053-2a95a90ac755.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57511-0002-1GM - Gram57511-00022478eaaf-6f4c-4846-9b63-6757203a13d512022-09-12

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 7 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natural Fluoride Fresh Mint cavity protection whitening fresh breathSODIUM FLUORIDETom's of Maine, Inc.fce5e8b5-34f8-4a45-a662-82c9034198092026-06-16WarningsExact identifier
unii: 8ZYQ1474W7
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
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
PEROXICARESODIUM FLUORIDEChurch & Dwight Co., Inc.55262538-15ce-455c-93b1-bb02b5f81d6b2026-06-07WarningsExact identifier
unii: 8ZYQ1474W7
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
Orajel Toy Story 5 AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.4b80947d-f389-2f80-e063-6294a90abd552026-06-01WarningsExact identifier
unii: 8ZYQ1474W7
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.54113245-0c1e-739e-e063-6294a90aea422026-06-01WarningsExact identifier
unii: 8ZYQ1474W7
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.545258fd-8179-fffc-e063-6394a90a467f2026-06-01WarningsExact identifier
unii: 8ZYQ1474W7
Orajel Paw PatrolSODIUM FLUORIDEChurch & Dwight Co., Inc.99d87bea-3e99-5d04-e053-2a95a90aaf542026-06-01WarningsExact identifier
unii: 8ZYQ1474W7
Orajel SuperMarioANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.27d2f6cb-8661-da9c-e063-6394a90a5bde2026-06-01WarningsExact identifier
unii: 8ZYQ1474W7
Orajel KidsToothpasteSODIUM FLUORIDEChurch & Dwight Co., Inc.99d62125-c2c5-5926-e053-2995a90aaa292026-06-01WarningsExact identifier
unii: 8ZYQ1474W7
AIM CAVITY PROTECTION Multi BenefitSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0f8a33-0b01-40e2-e054-00144ff88e882026-06-01WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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