FDA.reportPublic FDA data

Anticavity Fluoride

Product NDC
55319-193
11-digit product format
553190193
Labeler code
55319
Product ID
55319-193_c3f30f5b-9b5e-4515-bdff-80c5c37ef25d
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride and Acidulated Phosphate
Dosage form
LIQUID
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-02
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
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1666fff6-9a8b-40f9-ae53-914152db386bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-193-01Anticavity Fluoride1000 mL in 1 BOTTLE, PLASTICLIQUID10003

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 31 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oral Gel Oral Pain ReliefBENZOCAINE BENZALKONIUM CHLORIDESavvy Care and Cosmetics05ede7e4-5a0a-c942-e063-6294a90a8a242024-12-19WarningsExact identifier
application number: M022
EcoDent Ultimate Essential Mouthcare Sparkling Clean MintSODIUM BICARBONATELotus Brands, Inc.4a95c8c1-db7c-4791-ac58-3eac216a01262024-12-18WarningsExact identifier
application number: M022
EcoDent Ultimate Essential Mouthcare Spicy-Cool CinnamonSODIUM BICARBONATELotus Brands, Inc.6703b29d-cdc9-4c74-91c0-fb0c98dd043e2024-12-18WarningsExact identifier
application number: M022
Red Cross Oral Pain ReliefBENZOCAINEThe Mentholatum Companycbd41429-f730-4577-9f06-ef1831cf62e12024-12-17WarningsExact identifier
application number: M022
Red Cross Canker SoreBENZOCAINEThe Mentholatum Company54cfff96-6665-4b36-a15d-10bf6cf3a1f92024-12-17WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESIN1169566442981217f-f250-c090-e063-6294a90a85b02024-12-17WarningsExact identifier
application number: M022
Kank-A Mouth PainBENZOCAINEBlistex Inc.eebc03ba-f849-4e70-a653-834f383b6aa42024-12-17WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.8282a4a6-b77c-75fc-e053-2991aa0ad4ac2024-12-16WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories,Inc.9452bff4-8c08-eff9-e053-2a95a90a67ed2024-12-16WarningsExact identifier
application number: M022
PHENOLPHENOLCHAIN DRUG MARKETING ASSOCIATION INC.2379e23a-72fe-4e94-9d7e-9b623c0db1742024-12-13WarningsExact identifier
application number: M022
KANKA SoftBrushBENZOCAINE AND ZINC CHLORIDEBlistex Inc093f3545-1d8e-48a3-a533-e9c3ae6d740b2024-12-12WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.826eaef8-4457-3dc2-e053-2991aa0a528b2024-12-11WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.8281700c-10f9-841c-e053-2991aa0a918f2024-12-11WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.82824416-80de-76bd-e053-2a91aa0ad8b52024-12-11WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories,Inc.e3da0e63-a891-72bd-e053-2a95a90a58bc2024-12-11WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories, Inc.e3d924b5-0788-46d3-e053-2995a90a027b2024-12-11WarningsExact identifier
application number: M022
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.fa433031-7376-0e5b-e053-6394a90a5f752024-12-11WarningsExact identifier
application number: M022
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.eedf13dc-a009-027a-e053-2995a90a8ec82024-12-11WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola USA Inc.763e8234-60be-4b1f-9f78-01c574f35d0a2024-12-10WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola USA Inc.989f8509-cd28-48e7-9aa1-baddfbcac95a2024-12-10WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-193-01553190193011000 mL in 1 BOTTLE, PLASTIC (55319-193-01) 1000 ml2025-06-02NoNoCurrent