Anticavity

Product NDC
41163-971
11-digit product format
411630971
Labeler code
41163
Product ID
41163-971_4b0976e4-b8e3-b103-e063-6294a90ab5b2
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
RINSE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-01
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
Anticavity
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
9d055fed-26d8-4827-a4cc-8c314514a6c3Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-971-86Anticavity1000 mL in 1 BOTTLE, PLASTICRINSE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-971ANTICAVITY (SODIUM FLUORIDE) RINSE [UNITED NATURAL FOODS, INC. DBA UNFI]4Current NDC, 1 package rows20250330_9d055fed-26d8-4827-a4cc-8c314514a6c3.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 48 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.13910b55-9b5d-af53-e063-6294a90acf5d2024-03-13WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitudee3bb60f8-2a06-42d6-a182-8c31bb982a2a2024-03-01WarningsExact identifier
application number: M021
Maximum SecuritySODIUM FLUORIDEBob Barker Company Inc.e29f30ec-72ea-4944-a2c2-b1696d31b6392024-02-27WarningsExact identifier
application number: M021
Made by Dentists For Kids Monster Slime Sour AppleSODIUM FLUORIDEMADE BY DENTISTS INCdfddc67c-3626-48c4-8120-bcc6c455d1192024-02-23WarningsExact identifier
application number: M021
Orajel Gabbys DollhouseSODIUM FLUORIDEChurch & Dwight Co., Inc.cd47bd1e-44ac-465f-8529-6073ade147062024-02-23WarningsExact identifier
application number: M021
Colgate Kids Maximum Cavity ProtectionSODIUM FLUORIDEColgate-Palmolivec44c7a7e-fc3e-a81b-1961-ff89614b678f2024-02-22WarningsExact identifier
application number: M021
TheraBreath Fresh Breath Anticavity Mild MintSODIUM FLUORIDEChurch & Dwight Co., Inc.19ce5324-7d8d-4d70-ad9b-238f7e612eac2024-02-06WarningsExact identifier
application number: M021
Nature Mint AnticavitySODIUM MONOFLUOROPHOSPHATEBob Barker Company Inc.916891d3-5234-46a8-a492-21a31f36a8522024-02-02WarningsExact identifier
application number: M021
Treatment Rinse MintANTICARIESDENTAL ALLIANCE HOLDINGS LLCf1255065-b7c3-4eb6-e053-2995a90afcdb2024-01-31WarningsExact identifier
application number: M021
Maintenance Rinse MintANTICARIESDental Alliance Holdings LLCf1273510-aa83-3ef9-e053-2a95a90aea272024-01-31WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98d839e3-a1aa-c83d-e053-2995a90a7e792024-01-30WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98aebbec-aec0-1478-e053-2a95a90a03ea2024-01-30WarningsExact identifier
application number: M021
Toms Childrens Anticavity Mouthwash Silly StrawberrySODIUM FLUORIDETom's of Maine, Inc.998c6f35-20f4-4cb8-bc48-6aa39e61481a2024-01-18WarningsExact identifier
application number: M021
Gel-Kam Fruit and BerrySTANNOUS FLUORIDEColgate Oral Pharmaceuticals, Inc.8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c2024-01-18WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.9a976ac8-d966-4d94-93da-45652f2d24812024-01-12WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.2b4b6f9a-0e31-4891-8721-d1b9a58cca962024-01-12WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Cool MintSODIUM FLUORIDEColgate-Palmolive Company51abd6bc-7a3d-4b0e-a810-af9e949264382024-01-09WarningsExact identifier
application number: M021
Colgate Enamel Strength MouthwashSODIUM FLUORIDEColgate-Palmolive - do not usef0cca38b-c0a3-4788-8cca-727a5684c16b2024-01-09WarningsExact identifier
application number: M021
PerCara Oral Health Rinse Fresh MintCETYLPYRIDINIUM CHLORIDELEC Custom Products, Incbd98c654-218b-15ac-e053-2a95a90a75d12024-01-01WarningsExact identifier
application number: M021
PerCara Kids Bubble GumSODIUM FLUORIDELEC Custom Products, Inc.be3a7272-acfb-7d14-e053-2995a90a94202024-01-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN9d055fed-26d8-4827-a4cc-8c314514a6c35
313029sodium fluoride 0.2 MG/ML MouthwashSCD9d055fed-26d8-4827-a4cc-8c314514a6c35
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY9d055fed-26d8-4827-a4cc-8c314514a6c35
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY9d055fed-26d8-4827-a4cc-8c314514a6c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41163-971-86411630971861000 mL in 1 BOTTLE, PLASTIC (41163-971-86) 1000 ml2021-10-01NoNoCurrent