FDA.reportPublic FDA data

Anticavity Fluoride Rinse

Product NDC
56062-163
11-digit product format
560620163
Labeler code
56062
Product ID
56062-163_4f6d1d62-7254-4b82-e063-6394a90a7520
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Publix Super Markets, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-07-20
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 Fluoride Rinse
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
cb6850e9-ba3e-47ac-a3ca-5de4d57c01cbAvailable 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
56062-163-86Anticavity Fluoride Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
THYMOLINACTIVE INGREDIENT3J50XA376EANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-163ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [PUBLIX SUPER MARKETS, INC]12Current NDC, Legacy NDC, 1 package rows20240925_cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb.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 38 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL WHITENING SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35839b10-4c40-40e5-e063-6294a90a85b42025-05-19WarningsExact identifier
application number: M021
Hello Unicorn SparkleSODIUM FLUORIDEColgate-Palmolive Company5acfbd9b-278c-24dd-8041-5e2cdffbf7102025-05-13WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride Cotton CandySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC25f182cb-ad1e-4c13-bc79-1ec251754cf82025-05-12WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride WatermelonSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb506df13-649f-4615-bc25-6ae08bd56b182025-05-12WarningsExact identifier
application number: M021
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh MintSODIUM FLUORIDEKenvue Brands LLC346daeae-7590-176c-e063-6294a90a52ea2025-05-05WarningsExact identifier
application number: M021
Evo Sensitive Whitening Anti-cavity Fluoride MouthwashSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.3de0d71a-7704-97dd-e063-6294a90a5d2c2025-05-01WarningsExact identifier
application number: M021
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus ScopeSODIUM FLUORIDENavajo Manufacturing Company Inc3adb1524-0fd6-4728-b757-dcbda4cdd0fb2025-04-29WarningsExact identifier
application number: M021
Listerine Clinical Solutions Enamel Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC11e1c1d0-465b-9e14-e063-6394a90a8cdd2025-04-22WarningsExact identifier
application number: M021
Hello Mighty Multi taskerSTANNOUS FLUORIDEColgate-Palmolive Company48e36e06-3666-9032-b9c8-4be035e751f22025-04-15WarningsExact identifier
application number: M021
Hello Kids Wild Strawberry Wild StrawberrySODIUM FLUORIDEColgate-Palmolive Company39dddf11-45a0-b883-e12f-d80c582e8c892025-04-15WarningsExact identifier
application number: M021
Hello Magical MermaidSODIUM FLUORIDEColgate-Palmolive Companybdabf74f-8d1e-0f11-159a-0025bcd0ca3e2025-04-15WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.300303e7-ef8b-7449-e063-6294a90ac8112025-04-09WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.303d4ad0-5a2b-347a-e063-6394a90aa0ba2025-04-07WarningsExact identifier
application number: M021
OralLine KidsSODIUM FLUORIDEJ.M. Murray Center Inc.12c5bee5-e228-4f71-9bfd-c377ee2372a92025-03-21WarningsExact identifier
application number: M021
AdoptaPlatoonSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDc1592b56-cf3d-4a4d-be84-e40eb3f1456e2025-03-21WarningsExact identifier
application number: M021
OralLine SecureSODIUM FLUORIDEJ.M. Murray Center Inc.4c0970e9-7417-4234-89e3-3b602a609af52025-03-20WarningsExact identifier
application number: M021
smart way MINT cavity protectionSODIUM MONOFLUOROPHOSPHATEThe Kroger Co.45cc7a60-b4a7-4263-a114-f0d1f98a87fc2025-03-19WarningsExact identifier
application number: M021
HismileMAGICALLY DELICIOUS FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd309366f8-6a52-fe9f-e063-6394a90a5de32025-03-18WarningsExact identifier
application number: M021
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2b3e72ca-2bbb-adf1-e063-6394a90a2c7a2025-03-13WarningsExact identifier
application number: M021
Hismile Pink Lemonade Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2b92ff92-3722-3702-e063-6394a90a38b02025-03-13WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNcb6850e9-ba3e-47ac-a3ca-5de4d57c01cb15
313029sodium fluoride 0.2 MG/ML MouthwashSCDcb6850e9-ba3e-47ac-a3ca-5de4d57c01cb15
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYcb6850e9-ba3e-47ac-a3ca-5de4d57c01cb15
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYcb6850e9-ba3e-47ac-a3ca-5de4d57c01cb15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-163-86560620163861000 mL in 1 BOTTLE, PLASTIC (56062-163-86) 1000 ml2011-07-200000-00-00NoNoCurrent