FDA.reportPublic FDA data

Anticavity

Product NDC
41250-163
Requested package NDC
41250-163-86
11-digit product format
412500163
Labeler code
41250
Product ID
41250-163_4b32244e-5b7a-60d5-e063-6394a90a8d6e
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
2009-05-18
Substance
SODIUM FLUORIDE
Active strength
.2 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
Anticavity
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 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
c628d02f-c834-42b3-b38d-6b9cdcdd0961Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-163-082019-11-13C16284748780-197449f38-bbeb-f6ea-e053-dbdaa90aa703DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-163-86Anticavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100018
41250-163-08ANTIBACTERIAL FOAMINGPEAR221 mL in 1 BOTTLE, PUMPLIQUID2211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
TRICLOSANACTIVE MOIETY4NM5039Y5XANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0BANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
C12-16 ALCOHOLSINACTIVE INGREDIENTS4827SZE3LANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
POLYQUATERNIUM-10 (400 CPS AT 2%)INACTIVE INGREDIENTHB1401PQFSANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950URANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-163ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC]16Current NDC, Legacy NDC, 1 package rows20240214_c628d02f-c834-42b3-b38d-6b9cdcdd0961.zip
41250-163ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]1Current NDC, Legacy NDC, 1 package rows20111118_e4763fc7-2719-41e6-9c0d-2108c086877f.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
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNc628d02f-c834-42b3-b38d-6b9cdcdd096118
313029sodium fluoride 0.2 MG/ML MouthwashSCDc628d02f-c834-42b3-b38d-6b9cdcdd096118
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYc628d02f-c834-42b3-b38d-6b9cdcdd096118
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYc628d02f-c834-42b3-b38d-6b9cdcdd096118
1053855triclosan 0.46 % Medicated Liquid SoapPSNe4763fc7-2719-41e6-9c0d-2108c086877f1
1053855triclosan 4.6 MG/ML Medicated Liquid SoapSCDe4763fc7-2719-41e6-9c0d-2108c086877f1
1053855triclosan 0.46 % Foaming Medicated Hand SoapSYe4763fc7-2719-41e6-9c0d-2108c086877f1
1053855triclosan 0.46 % Medicated Liquid SoapSYe4763fc7-2719-41e6-9c0d-2108c086877f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-163-86412500163861000 mL in 1 BOTTLE, PLASTIC (41250-163-86) 1000 ml2009-05-180000-00-00NoNoCurrent