FDA.reportPublic FDA data

Rorobell WaWa Tooth

Product NDC
81275-010
11-digit product format
812750010
Labeler code
81275
Product ID
81275-010_5821995e-620b-385b-e063-6294a90a5c97
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
ROROBELL
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
.72 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Rorobell WaWa Tooth
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.72 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2471311Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
93113481-ad9d-4be0-a7b7-a72c8726127dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81275-010-01Rorobell WaWa Tooth100 g in 1 TUBEPASTE, DENTIFRICE1004
81275-010-02Rorobell WaWa Tooth1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81275-010ROROBELL WAWA TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROROBELL]3Current NDC, Legacy NDC, 2 package rows20241210_93113481-ad9d-4be0-a7b7-a72c8726127d.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 31 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba491f4-2ad2-6e7b-e063-6394a90a9fb72025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188ac743-3ba8-4da4-e063-6294a90a8f872025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b682604-c563-01f1-e063-6294a90ab0bd2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b110db1-fcc0-377f-e063-6394a90a4d442025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74ecc4-a1e6-348f-e063-6294a90a58942025-12-11Exact identifier
application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b68315c-6afa-3f37-e063-6294a90a14e82025-12-11WarningsExact identifier
application number: M021
ANTICAVITY FLUORIDESODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD295b88e8-c4b5-c0b0-e063-6394a90aca012025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74f072-c33b-c6e2-e063-6394a90ab1e62025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba4a807-d6d5-04a0-e063-6294a90ae04d2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b617f4a-b56c-9f75-e063-6294a90a7abe2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b9ec370-eadf-92c4-e063-6294a90a90552025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVORSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1eb04296-ecb1-3ccc-e063-6294a90a9bda2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b9e7b21-0d34-74ec-e063-6294a90a1f592025-12-11Exact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry SplashSODIUM FLUORIDEKenvue Brands LLC28986d7f-3e9a-8dfb-e063-6394a90a731e2025-12-10WarningsExact identifier
application number: M021
Toms of Maine Tropical IslandALUMINUM CHLOROHYDRATEColgate-Palmolive Company0d6c51bc-5391-4533-b4fd-961dc4f363422025-12-10WarningsExact identifier
application number: M021
Business Class KitSODIUM MONOFLUOROPHOSPHATEAmerican Airlines, Inc.483d7aec-34ac-49c5-ac0e-8fba5b4737ae2025-12-09WarningsExact identifier
application number: M021
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd121decce-c364-4060-87da-0c6a6cd484742025-12-08WarningsExact identifier
application number: M021
First Class KitSODIUM MONOFLUOROPHOSPHATEAmerican Airlines, Inc.ba717de8-c3a2-41bf-85a1-aa75f9744d302025-12-08WarningsExact identifier
application number: M021
United Airlines Business Class KitSODIUM MONOFLUOROPHOSPHATEUnited Airlines94c5e9a4-19f3-4590-9da4-313c752612312025-12-08WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC5f08d994-e458-42b2-aa39-e84fca3acf482025-12-05WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2471311sodium monofluorophosphate 0.72 % ToothpastePSN93113481-ad9d-4be0-a7b7-a72c8726127d4
2471311sodium monofluorophosphate 0.0072 MG/MG ToothpasteSCD93113481-ad9d-4be0-a7b7-a72c8726127d4
2471311sodium monofluorophosphate 0.72 % ToothpasteSY93113481-ad9d-4be0-a7b7-a72c8726127d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81275-010-0181275001001100 g in 1 TUBE100 gHistorical
81275-010-02812750010021 TUBE in 1 CARTON (81275-010-02) / 100 g in 1 TUBE (81275-010-01) 1 tube2020-12-010000-00-00NoNoCurrent