FDA.reportPublic FDA data

Anticavity Rinse

Product NDC
41250-004
11-digit product format
412500004
Labeler code
41250
Product ID
41250-004_4b318df0-16aa-afb2-e063-6394a90ace68
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
2002-06-27
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 Rinse
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
240698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
001777fb-196c-499a-94c8-6cdcef0958e9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-004-44Anticavity Rinse532 mL in 1 BOTTLE, PLASTICMOUTHWASH53219

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-004ANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC.]18Current NDC, Legacy NDC, 1 package rows20250311_001777fb-196c-499a-94c8-6cdcef0958e9.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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN001777fb-196c-499a-94c8-6cdcef0958e919
240698sodium fluoride 0.5 MG/ML MouthwashSCD001777fb-196c-499a-94c8-6cdcef0958e919
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY001777fb-196c-499a-94c8-6cdcef0958e919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-004-4441250000444532 mL in 1 BOTTLE, PLASTIC (41250-004-44) 532 ml2002-06-270000-00-00NoNoCurrent