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 32 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
application number: M021
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
application number: M021
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
application number: M021
365 Everyday Value Cavity Fighting and WhiteningSODIUM MONOFLOUROPHOSPHATEWhole Foods Market, Inc.83704717-19bc-2634-e053-2991aa0a29792025-11-21WarningsExact identifier
application number: M021
WhiteningMONOFLUOROPHOSPHATETarget0074630f-9d8d-9209-e063-6294a90a4f012025-11-21WarningsExact identifier
application number: M021
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
application number: M021
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
application number: M021
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
application number: M021
CVS Pharmacy Restore and DefendFLUORIDECVS Pharmacy99f86135-05b7-42b1-aef5-df4513259b8f2025-11-14WarningsExact identifier
application number: M021
HEB HEBuddyFLUORIDEHEBa6af1baf-17bf-428c-8744-1490359b0cfb2025-11-13WarningsExact identifier
application number: M021
Spearmint Whitening with Hemp OilSODIUM MONOFLUOROPHOSPHATEWhole Foodsa4714db7-abc4-1eff-e053-2995a90a77402025-11-13WarningsExact identifier
application number: M021
Complete Protection TPSTANNOUS FLUORIDERite Aidccad28b5-254e-679f-e053-2a95a90abdd52025-11-13WarningsExact identifier
application number: M021
Rite Aid Sensitivity and GumSTANNOUS FLUORIDERite Aided362e9c-2dab-1102-e053-2a95a90a76f32025-11-13WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEMeijer, Inc.0338495b-08a5-047f-e063-6394a90aa1242025-11-13WarningsExact 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