FDA.reportPublic FDA data

Anticavity Fluoride

Product NDC
55319-807
11-digit product format
553190807
Labeler code
55319
Product ID
55319-807_55150efe-465e-4f46-ab4e-c75b2b085a46
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
MOUTHWASH
Route
DENTAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
SODIUM FLUORIDE
Active strength
.05 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.05 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
63c4c0e9-84b1-4076-bdf4-7e9543b2cf46Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-807-18Anticavity Fluoride500 mL in 1 BOTTLE, PLASTICMOUTHWASH5004

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 9 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Restore and DefendSTANNOUS FLUORIDEWalgreense808ea4b-9081-085b-e053-2a95a90a4f9b2026-06-02WarningsExact identifier
application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinseSODIUM FLUORIDEColgate-Palmolive Companya1014431-7d23-aaff-6dc7-ab58683d03382026-06-02WarningsExact identifier
application number: M021
Therabreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.feab3d45-ff95-4b32-8258-7d932a7380c92026-06-01WarningsExact identifier
application number: M021
Orajel Toy Story 5 AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.4b80947d-f389-2f80-e063-6294a90abd552026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.54113245-0c1e-739e-e063-6294a90aea422026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.545258fd-8179-fffc-e063-6394a90a467f2026-06-01WarningsExact identifier
application number: M021
Orajel Paw PatrolSODIUM FLUORIDEChurch & Dwight Co., Inc.99d87bea-3e99-5d04-e053-2a95a90aaf542026-06-01WarningsExact identifier
application number: M021
Orajel SuperMarioANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.27d2f6cb-8661-da9c-e063-6394a90a5bde2026-06-01WarningsExact identifier
application number: M021
Orajel KidsToothpasteSODIUM FLUORIDEChurch & Dwight Co., Inc.99d62125-c2c5-5926-e053-2995a90aaa292026-06-01WarningsExact identifier
application number: M021
AIM CAVITY PROTECTION Multi BenefitSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0f8a33-0b01-40e2-e054-00144ff88e882026-06-01WarningsExact identifier
application number: M021
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560980ea-749f-593d-e063-6394a90a1b9e2026-06-01WarningsExact identifier
application number: M021
Colgate Revitalizing WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyc67223ae-b068-41c5-a15b-7ae9840b93ef2026-05-27WarningsExact identifier
application number: M021
Colgate Kids Harry PotterSODIUM FLUORIDEColgate-Palmolive Company61c06da4-9f02-4fbc-b80f-1c443e2984962026-05-26WarningsExact identifier
application number: M021
sodium fluoride rinseSODIUM FLUORIDE RINSERockland Cosmetics, Inc.52430b12-4d5f-d1e1-e063-6394a90abd642026-05-20Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E Bd0a52519-3339-40ea-93e5-78f76d348a4d2026-05-14Warnings, Adverse reactionsExact identifier
application number: M021
Burts Bees Extra WhiteSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc92524fd-8b93-592d-e053-2a95a90a88c62026-05-13WarningsExact identifier
application number: M021
MIPaste Plus StrawberrySODIUM FLUORIDEGC America Inc.1b68bd67-65d3-4c64-e054-00144ff8d46c2026-05-12WarningsExact identifier
application number: M021
White Glo Purple Color Corrector Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc6f8b77c3-9833-4c75-b41c-a2bc126161572026-05-12WarningsExact identifier
application number: M021
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
application number: M021
Morning Fresh Mint Toothpaste, with FluorideMORNING FRESH MINT TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a42d8ce-e7f2-caa5-e063-6294a90ac01f2026-05-07WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-807-1855319080718500 mL in 1 BOTTLE, PLASTIC (55319-807-18) 500 ml2025-10-01NoNoCurrent