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 2 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids Flouride RinseSODIUM FLUORIDEYour Military Exchanges5f6f4125-6264-4724-bb7e-a6e100939b412026-08-28Warnings, Adverse reactionsExact identifier
application number: M021
Colgate MaxFresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-26WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-26WarningsExact identifier
application number: M021
COLGATE 2IN1 ICY BLASTSODIUM FLUORIDEColgate-Palmolive Company6aad9a91-ba1c-4a27-9269-ea8032feaad02026-08-26WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company59dff762-7f66-8bdc-e063-6294a90a9f182026-08-25WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
Colgate Sensitive ProRelief WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company8d9d485e-6efb-4bca-a779-9e8b0aeed14c2026-08-18WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact 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