FDA.reportPublic FDA data

Ipana Wintergreen Fluoride

Product NDC
69510-010
11-digit product format
695100010
Labeler code
69510
Product ID
69510-010_3b02acf1-478c-5a1f-e063-6294a90a9a1c
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE
Route
DENTAL
Labeler
Maxill Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-31
Marketing end
2029-07-31
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
.1 g/100g
NDC exclude flag
No
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
Ipana Wintergreen Fluoride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.1 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
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69510-010-19Ipana Wintergreen Fluoride1 in 1 BOXPASTE19
69510-010-19Ipana Wintergreen Fluoride19 g in 1 TUBEPASTE199

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
CarboxymethylcelluloseINACTIVE INGREDIENT05JZI7B19XIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RIPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69510-010IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]8Current NDC, Legacy NDC, 2 package rows20241018_5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0.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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
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
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN5776cc3e-4fd1-4bd7-8d82-f82508e6b8d09
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5776cc3e-4fd1-4bd7-8d82-f82508e6b8d09
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5776cc3e-4fd1-4bd7-8d82-f82508e6b8d09
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5776cc3e-4fd1-4bd7-8d82-f82508e6b8d09
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5776cc3e-4fd1-4bd7-8d82-f82508e6b8d09
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5776cc3e-4fd1-4bd7-8d82-f82508e6b8d09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69510-010-19695100010191 TUBE in 1 BOX (69510-010-19) / 19 g in 1 TUBE1 tube2015-01-052029-07-31NoNoCurrent