FDA.reportPublic FDA data

Oral Antivavity

Product NDC
30142-576
11-digit product format
301420576
Labeler code
30142
Product ID
30142-576_4bd14d76-c9aa-ca59-e063-6394a90a7a89
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
The Kroger Co.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-06
Substance
SODIUM FLUORIDE
Active strength
10.41 mg/mL
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
Oral Antivavity
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE10.41 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
932723b8-9875-4f37-8c11-018c94ae0ae1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-576-86Oral Antivavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1
WATERINACTIVE INGREDIENT059QF0KO0RORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-576ORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [KROGER CO]13Current NDC, Legacy NDC, 1 package rows20250206_932723b8-9875-4f37-8c11-018c94ae0ae1.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-576-86301420576861000 mL in 1 BOTTLE, PLASTIC (30142-576-86) 1000 ml2015-02-060000-00-00NoNoCurrent