FDA.reportPublic FDA data

ATOMY ANTICAVITY TOOTH

Product NDC
52257-1470
11-digit product format
522571470
Labeler code
52257
Product ID
52257-1470_592cacf6-053f-c9c9-e063-6294a90a98a9
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
ATOMY CO., LTD.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
.76 g/100g
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
ATOMY ANTICAVITY TOOTH
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.76 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
592caccc-e3a9-9c66-e063-6394a90a26e3Available on FDA.report

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 21 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HismileSTRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef766ae-754a-f185-e063-6294a90a32992026-01-15WarningsExact identifier
application number: M021
HismileBANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef7be5b-df8f-9f32-e063-6394a90a47242026-01-15WarningsExact identifier
application number: M021
HismileVANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef8d0ef-a051-f610-e063-6394a90a85372026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d40b98b-2e9a-d84a-e063-6294a90a20962026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d44863e-93be-2b80-e063-6294a90a4a9d2026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d458ccc-8f1e-f9c8-e063-6294a90a8da42026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d447939-fbf6-42f6-e063-6294a90af6d92026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1de591d9-9cab-e63d-e063-6394a90ac8eb2026-01-15WarningsExact identifier
application number: M021
Ice Pop Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD20e1603e-bcd1-6a5e-e063-6294a90ad1db2026-01-15WarningsExact identifier
application number: M021
HismileCANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHISMILE PTY LTD1e725b7e-accc-f51c-e063-6394a90a455c2026-01-15WarningsExact identifier
application number: M021
Enamelon Preventive TreatmentSTANNOUS FLUORIDEPremier Dental Products Company04c3f178-7905-404d-9ac2-67c453287ddf2026-01-13WarningsExact identifier
application number: M021
EnamelonSTANNOUS FLUORIDEPremier Dental Products Company1626375a-f78b-4192-b7f3-ca932acab7fb2026-01-13WarningsExact identifier
application number: M021
ARU CAVITY PROTECTIONSODIUM FLUORIDEAshtel Studios, Inc.97bd2934-4bff-4fdb-9199-fcdc0f77fada2026-01-13WarningsExact identifier
application number: M021
ACT Anticavity Fluoride CinnamonSODIUM FLUORIDEChattem, Inc.f2952ca5-c1c3-42fc-82a4-08662286be442026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Wild WatermelonSODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)Chattem, Inc.bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a82026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Pineapple PunchSODIUM FLUORIDEChattem, Inc.2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b2026-01-12WarningsExact identifier
application number: M021
Botao Kids Strawberry Flavored with FluorideBOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDEPeer Pharm Ltd.48b8d884-5e15-4145-8521-ae9ee482e3922026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.4ee6a478-afcf-4540-b427-ba08c942ccb32026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride MintSODIUM FLUORIDEChattem, Inc.e81c83a2-363a-442f-8731-2598a4f4c21e2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.258b78b4-55e7-410c-90f8-a3e456c025792026-01-12WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52257-1470-2522571470024 TUBE in 1 CARTON (52257-1470-2) / 50 g in 1 TUBE (52257-1470-1) 4 tube2026-08-01NoNoCurrent
52257-1470-4522571470041 TUBE in 1 CARTON (52257-1470-4) / 200 g in 1 TUBE (52257-1470-3) 1 tube2026-08-01NoNoCurrent