FDA.reportPublic FDA data

Anticavity

Product NDC
36800-971
11-digit product format
368000971
Labeler code
36800
Product ID
36800-971_4aba08c6-5e06-e60a-e063-6394a90abde8
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
RINSE
Route
ORAL
Labeler
Topco Associates LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-19
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
a9b8b2fe-0a60-4f65-b6f6-aae8509c919fAvailable 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
36800-971-86Anticavity1000 mL in 1 BOTTLE, PLASTICRINSE100015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1
waterINACTIVE INGREDIENT059QF0KO0RANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-971ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]14Current NDC, Legacy NDC, 1 package rows20250328_a9b8b2fe-0a60-4f65-b6f6-aae8509c919f.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 35 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gerigentle-Good morningSODIUM FLORIDEGeri-Gentle Corporatione69b3767-00c5-a535-e053-2995a90ad2152025-10-23WarningsExact identifier
application number: M021
Hello Penguin ChillSODIUM FLUORIDEColgate-Palmolive Company5c47a7d5-da34-4658-8006-b36f6477cb9b2025-10-23WarningsExact identifier
application number: M021
Auraglow WhiteningSODIUM FLUORIDEAuraglow LLC9d45e436-92f6-4a9e-9b82-329847dca9ba2025-10-22WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyed20cf9d-6162-4337-bb0b-1a6a6e9e1dc32025-10-21WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitudede21b326-f885-464b-b2df-f3866a0b3e9a2025-10-20WarningsExact identifier
application number: M021
Target Kids Watermelon MintSODIUM FLUORIDETarget35bc2e4d-f1c7-438e-e063-6394a90aead02025-10-17WarningsExact identifier
application number: M021
MediChoice FluorideSODIUM MONOFLUOROPHOSPHATEO&M HALYARD, INC.a87956fa-8975-4a44-9e9a-4b2191e401fe2025-10-09WarningsExact identifier
application number: M021
BRUSH BUDDIES BARBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b6f893d-74ac-421e-a78b-f495ac425af02025-10-09WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.a3e989f8-e6a2-4e13-8faa-77e95895166d2025-10-09WarningsExact identifier
application number: M021
TARGET UP AND UP ANTICAVITYSODIUM FLUORIDE 0.05%TARGET CORPORATION2992efce-1c66-df40-e063-6294a90ab3c02025-10-08WarningsExact identifier
application number: M021
MediChoice Premium Anticavity FluorideSODIUM FLUORIDEO&M HALYARD, INC.c6ba9b51-b958-4836-adc8-871529a43fc62025-10-08WarningsExact identifier
application number: M021
TidaloveSPICY CINNAMON TOOTHPASTE TABLETSParanmare LLC4092fcbf-27f7-b067-e063-6394a90a41c62025-10-07WarningsExact identifier
application number: M021
TidaloveCOOL MINT TOOTHPASTE TABLETSParanmare LLC4093060c-23a5-c77a-e063-6394a90a93042025-10-07WarningsExact identifier
application number: M021
TidaloveYUZU MINT TOOTHPASTE TABLETSParanmare LLC40946943-21cf-b114-e063-6394a90aed3f2025-10-07WarningsExact identifier
application number: M021
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCfdb16e59-5be1-4bd0-a940-d542d67fb2df2025-10-02WarningsExact identifier
application number: M021
Intensive Enamel Repair Whitening TPINTENSIVE ENAMEL REPAIR WHITENING TPTopco Associates LLC3012a8da-7595-2f7c-e063-6294a90ae1202025-09-30WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INCb2ad2b19-6fdf-454d-9b1d-49b1c81016fd2025-09-30WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.a38363e6-7105-4663-95a0-09ecb2948f832025-09-30WarningsExact identifier
application number: M021
UNPA CHA CHA TOOTHPASTESODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD3fae966e-0246-b9f2-e063-6394a90a494c2025-09-26WarningsExact identifier
application number: M021
Cloveden ToothSODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD3fb01bea-7205-49ba-e063-6294a90a38412025-09-26WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNa9b8b2fe-0a60-4f65-b6f6-aae8509c919f15
313029sodium fluoride 0.2 MG/ML MouthwashSCDa9b8b2fe-0a60-4f65-b6f6-aae8509c919f15
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYa9b8b2fe-0a60-4f65-b6f6-aae8509c919f15
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYa9b8b2fe-0a60-4f65-b6f6-aae8509c919f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-971-86368000971861000 mL in 1 BOTTLE, PLASTIC (36800-971-86) 1000 ml2013-09-190000-00-00NoNoCurrent