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 19 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Caref5252b4f-5e14-509e-e053-2995a90a6db82025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f199947-bf25-914b-e063-6394a90a8a6f2025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f199947-bf28-914b-e063-6394a90a8a6f2025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f19a1a7-c234-8d26-e063-6394a90ad7e92025-09-18WarningsExact identifier
application number: M022
McKesson Orasol GelBENZOCAINE 20%McKesson Medical-Surgicalcc8724f4-c482-5e7d-e053-2a95a90a608f2025-09-09WarningsExact identifier
application number: M022
MGC Health Drops Sugar Free Lemon MintMENTHOLMedical Group Care LLC3d70bca7-e830-e693-e063-6294a90a73f92025-08-28WarningsExact identifier
application number: M022
Exchange Select Drops Sugar Free Lemon MintMENTHOLArmy & Air Force Exchange Service3d70450f-04ea-1885-e063-6294a90a05bd2025-08-28WarningsExact identifier
application number: M022
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa2bad-5b8b-8aac-e063-6394a90a9f492025-08-27WarningsExact identifier
application number: M022
R CosCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa767a-1344-5ed9-e063-6394a90a5fe62025-08-27WarningsExact identifier
application number: M022
Na Mi CalCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cfbcd1-eb13-933c-e063-6294a90a7e592025-08-27WarningsExact identifier
application number: M022
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cf8f80-c638-4d94-e063-6294a90a54002025-08-27WarningsExact identifier
application number: M022
Charm Tex FLUORIDESODIUM MONOFLUOROPHOSPHATEYangzhou Hongshengding Chemical Co.,Ltd.63a69664-8611-4d69-b871-8d1d5b553e5c2025-08-18WarningsExact identifier
application number: M022
QUALITY CHOICE SALINESODIUM CHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f51491d8-12ad-4b1b-a171-c621bfdcc3412025-08-12WarningsExact identifier
application number: M022
MGC Health Drops Sugar Free Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.b9227966-847c-40c3-87f2-8bea3954ec842025-08-12WarningsExact identifier
application number: M022
Exchange Select Drops Sugar Free Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.5f4b1960-43ac-4c74-9410-210c48bd8a1b2025-08-12WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC113cdb83-0fdd-40f2-8ee6-b771dca997132025-08-12WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy13bf31c1-78e3-459f-9249-b0b6e2c17a132025-08-12WarningsExact identifier
application number: M022
Rexall Maximum StrengthBENZOCAINERexall8f6e2780-cfb7-4bef-9b7d-13cb80d8923e2025-08-12WarningsExact identifier
application number: M022
Walgreens Maximum StrengthBENZOCAINEWalgreens8f24309d-d393-455a-a9a5-a55344adf36b2025-08-12WarningsExact identifier
application number: M022
Oral Anesthetic LiquidBENZOCAINEMeijer, Inc.0321c480-e150-421d-e063-6294a90ad6872025-08-12WarningsExact 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