FDA.reportPublic FDA data

Prime Tooth Care Mango Smoothie

Product NDC
87053-005
11-digit product format
870530005
Labeler code
87053
Product ID
87053-005_47f51ae4-adb0-1f0d-e063-6294a90a83c1
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
OINTMENT
Route
DENTAL
Labeler
Prime Tooth Care LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-31
Substance
SODIUM FLUORIDE
Active strength
2.5 mg/g
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
Prime Tooth Care Mango Smoothie
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.5 mg/g

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
2f2cf851-2edc-4aaf-9083-c37bc58547deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
87053-005-00Prime Tooth Care Mango Smoothie1 in 1 BOXOINTMENT12
87053-005-00Prime Tooth Care Mango Smoothie65 g in 1 TUBEOINTMENT652

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 8 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Plus Scope plus Whitening Minty Fresh with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ed8e02-3c2f-750c-e063-6394a90a4d332026-06-23WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEH E Bc68b0644-685d-4c62-bf5d-3a5bbea3b0522026-06-22Warnings, Adverse reactionsExact identifier
application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.fdbadaae-eab7-4d9a-acf7-815ca93f877c2026-06-16WarningsExact identifier
application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breathSODIUM FLUORIDETom's of Maine, Inc.fce5e8b5-34f8-4a45-a662-82c9034198092026-06-16WarningsExact identifier
application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.ebb62015-0027-459a-a9cf-56b640f9f4562026-06-16WarningsExact identifier
application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protectionSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.b9962eac-186e-4da2-929d-393f18ed02342026-06-16WarningsExact identifier
application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protectionSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.1c029b10-29b0-4131-9134-cebfca4328a32026-06-16WarningsExact identifier
application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTARSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.3e7ab39a-989c-4924-af3e-689404912bee2026-06-16WarningsExact identifier
application number: M021
Crest Plus Cinnamon plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company53fb780d-3e8b-6747-e063-6294a90a82112026-06-11WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY7f6b6aa8-50da-151b-c448-9e427d37398f2026-06-11WarningsExact identifier
application number: M021
Colgate MaxClean with Whitening SmartfoamSODIUM FLUORIDEColgate-Palmolive Companyc712ae6b-eff3-4c54-b1fc-37304758d0592026-06-11WarningsExact identifier
application number: M021
Colgate Total Sensitivity Mineral ShieldSTANNOUS FLUORIDEColgate-Palmolive Companyf065318c-1e2a-c04d-f254-f8127b05a88f2026-06-10WarningsExact identifier
application number: M021
Toms Whole Care Mouthwash Fresh MintSODIUM FLUORIDETom's of Maine, Inc.6875f5c1-853c-43da-8226-c09a5518f9bb2026-06-10WarningsExact identifier
application number: M021
Colgate Total SF Fresh Mint StripeSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY657020c7-e85c-4c61-9f62-b50351e4b4e52026-06-10WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride BubblegumSODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc1adc752b-2ba8-4d8f-b4f1-5741f864255b2026-06-09WarningsExact identifier
application number: M021
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.df182c22-bbf1-448d-81e8-35cb431d2afc2026-06-08WarningsExact identifier
application number: M021
PEROXICARESODIUM FLUORIDEChurch & Dwight Co., Inc.55262538-15ce-455c-93b1-bb02b5f81d6b2026-06-07WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride RaspberrySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc57e1d1cb-da58-4cd2-b960-4056e0b0d2142026-06-05WarningsExact identifier
application number: M021
3ECARE Dual FormulaWhiteningToothpasteSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.533fb7dd-7f84-59c5-e063-6394a90accad2026-06-02WarningsExact identifier
application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteethPOTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATEHangzhou Namei Zhikang Technology Co., Ltd.533fc83e-a8cf-15c1-e063-6294a90a7b742026-06-02WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87053-005-00870530005001 TUBE in 1 BOX (87053-005-00) / 65 g in 1 TUBE1 tube2025-08-31NoNoCurrent