FDA.reportPublic FDA data

Oral Antivavity

Product NDC
41250-576
11-digit product format
412500576
Labeler code
41250
Product ID
41250-576_4b33fb12-ad0a-8dd2-e063-6294a90a032b
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Meijer, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-06
Substance
SODIUM FLUORIDE
Active strength
.1 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 FLUORIDE.1 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313029Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af34f83f-1328-4897-9d04-72ca5a4101bfAvailable 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
41250-576-86Oral Antivavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100013

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-576ORAL ANTIVAVITY (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC]12Current NDC, Legacy NDC, 1 package rows20250423_af34f83f-1328-4897-9d04-72ca5a4101bf.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 32 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
application number: M021
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
application number: M021
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
application number: M021
365 Everyday Value Cavity Fighting and WhiteningSODIUM MONOFLOUROPHOSPHATEWhole Foods Market, Inc.83704717-19bc-2634-e053-2991aa0a29792025-11-21WarningsExact identifier
application number: M021
WhiteningMONOFLUOROPHOSPHATETarget0074630f-9d8d-9209-e063-6294a90a4f012025-11-21WarningsExact identifier
application number: M021
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
application number: M021
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
application number: M021
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
application number: M021
CVS Pharmacy Restore and DefendFLUORIDECVS Pharmacy99f86135-05b7-42b1-aef5-df4513259b8f2025-11-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNaf34f83f-1328-4897-9d04-72ca5a4101bf13
313029sodium fluoride 0.2 MG/ML MouthwashSCDaf34f83f-1328-4897-9d04-72ca5a4101bf13
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYaf34f83f-1328-4897-9d04-72ca5a4101bf13
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYaf34f83f-1328-4897-9d04-72ca5a4101bf13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-576-86412500576861000 mL in 1 BOTTLE, PLASTIC (41250-576-86) 1000 ml2015-02-060000-00-00NoNoCurrent