Care One Restore and Defend

Product NDC
41520-722
11-digit product format
415200722
Labeler code
41520
Product ID
41520-722_436ba302-220c-1f0e-e063-6294a90a11ac
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Foodhold U.S.A.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-11
Substance
STANNOUS FLUORIDE
Active strength
.15 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Care One Restore and Defend
Brand name suffix
Sensitive Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81a380eb-8605-b280-e053-2a91aa0abd4bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-722-19Care One Restore and DefendSensitive Whitening1 in 1 CARTONPASTE, DENTIFRICE17
41520-722-19Care One Restore and DefendSensitive Whitening96.3 g in 1 TUBEPASTE, DENTIFRICE96.37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-722CARE ONE RESTORE AND DEFEND SENSITIVE WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [FOODHOLD U.S.A.]5Current NDC, Legacy NDC, 2 package rows20250119_81a380eb-8605-b280-e053-2a91aa0abd4b.zip

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 15 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity Fluoride RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32ebc633-5338-4d5a-b075-f10b247612482026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEH E B51ddc81b-1c90-4998-b538-6761ac1134372026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.9a0b6301-2443-41f7-adeb-87578a65c26d2026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.344c9d00-ad82-46a9-83e9-68197e1a68bb2026-02-23Warnings, Adverse reactionsExact identifier
application number: M021
TheraBreath Complete Oral RinseANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.27c33ae1-52c7-baad-e063-6394a90a06112026-02-23WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEMeijer, Inc.001777fb-196c-499a-94c8-6cdcef0958e92026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.c628d02f-c834-42b3-b38d-6b9cdcdd09612026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEMeijer, Inc.b17f7a5d-272e-446d-803b-46a6d8e5f18f2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEMeijer, Inc.d85ce60c-ebff-461f-827a-10fddb9c2bf32026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
White Glo Charcoal Baking Soda Maximum White Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc580c4622-6f9c-48ea-b01e-6ffba7273f242026-02-19WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Incf044e213-2403-4f42-a41d-72d58fefcfcb2026-02-19WarningsExact identifier
application number: M021
White Glo Mouthwash Protect Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc4691584f-8c0c-4589-8b40-89b1779a438d2026-02-19WarningsExact identifier
application number: M021
White Glo Professional Choice Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inced8d7506-0385-4422-be77-bcc2db79882f2026-02-19WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEMeijer, Inc.c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEMeijer, Inc.af34f83f-1328-4897-9d04-72ca5a4101bf2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.acff939e-e98c-4d89-a0c4-0254dc74e6722026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity fluoride rinseSODIUM FLUORIDEMeijer, Inc.0bb9fb5f-1893-4187-b60b-05319a8fac6a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Listerine Total Care Intense Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC4b0404af-309f-7c31-e063-6294a90a5aa12026-02-18WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETarget Corporationabfc1973-60ab-44e5-8147-33739d8bd7a32026-02-18Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETarget Corporation3e4119b2-9506-4305-8cff-163f700265d02026-02-18Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN81a380eb-8605-b280-e053-2a91aa0abd4b7
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD81a380eb-8605-b280-e053-2a91aa0abd4b7
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY81a380eb-8605-b280-e053-2a91aa0abd4b7
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY81a380eb-8605-b280-e053-2a91aa0abd4b7
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY81a380eb-8605-b280-e053-2a91aa0abd4b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-722-19415200722191 TUBE in 1 CARTON (41520-722-19) / 96.3 g in 1 TUBE1 tube2019-02-110000-00-00NoNoCurrent