FDA.reportPublic FDA data

Just For Kids

Product NDC
48878-4070
11-digit product format
488784070
Labeler code
48878
Product ID
48878-4070_63113ead-d11c-4d64-9a8f-e97caa60943e
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
GEL
Route
ORAL
Labeler
Solventum US LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1997-07-01
Substance
STANNOUS FLUORIDE
Active strength
.969 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Just For Kids
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.969 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
237847Internal RxNorm lookup
1192947Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f1afc36-f699-4072-b90b-c9f5be989a49Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48878-4070-3Just For Kids1 in 1 BOXGEL16
48878-4070-3Just For Kids121.9 g in 1 TUBEGEL121.96

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48878-4070-3GM - Gram48878-4070d9b8aade-1a77-48af-a78b-da4f6cce692712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
stannous fluorideACTIVE INGREDIENT3FTR44B32QJUST FOR KIDS (STANNOUS FLUORIDE) GEL [3M ESPE DENTAL PRODUCTS]1
fluoride ionACTIVE MOIETYQ80VPU408OJUST FOR KIDS (STANNOUS FLUORIDE) GEL [3M ESPE DENTAL PRODUCTS]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXJUST FOR KIDS (STANNOUS FLUORIDE) GEL [3M ESPE DENTAL PRODUCTS]1
hydroxyethyl cellulose (2000 cps at 1%)INACTIVE INGREDIENTS38J6RZN16JUST FOR KIDS (STANNOUS FLUORIDE) GEL [3M ESPE DENTAL PRODUCTS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48878-4070JUST FOR KIDS (STANNOUS FLUORIDE) GEL [SOLVENTUM US LLC]6Current NDC, Legacy NDC, 2 package rows20240807_0f1afc36-f699-4072-b90b-c9f5be989a49.zip

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 28 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro-Health Gum Detoxify PlusSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f9e346e-d664-81d5-e063-6394a90a45252026-01-08WarningsExact identifier
application number: M021
Crest 3D White Holiday Smile Deep Stain Remover and WhitestripsSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company3c57d487-a3c7-b238-e063-6294a90aed812026-01-08Exact identifier
application number: M021
Crest Complete plus Scope Pro Advanced FreshnessSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company325c3ab2-aaa2-a06f-e063-6294a90abefb2026-01-08WarningsExact identifier
application number: M021
Crest Tartar ProtectionSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.5940711d-71b7-cb7d-e053-2a91aa0aef182026-01-08WarningsExact identifier
application number: M021
Meijer Restore and Defend SensitiveSTANNOUS FLUORIDEMeijer Distribution Inc82bdfdb5-39f2-8c09-e053-2991aa0a096c2026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f69824-e886-6e7b-e063-6294a90acf772026-01-08WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.01f64874-6363-3dcc-e063-6394a90a2aec2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Fresh MintSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f27a63-15f3-cee4-e063-6394a90afa3b2026-01-08WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.01f618d7-be07-18c3-e063-6294a90a2d972026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f35279-76ce-6027-e063-6294a90a8e342026-01-08WarningsExact identifier
application number: M021
Crest SnowberrySTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company42ca1f06-3e7d-8fed-e063-6394a90afbff2026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.7d615c52-f9c9-4856-e053-2991aa0a79272026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.5a1bb1fb-12a5-5fd1-e053-2991aa0a628b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.8de12c9f-eb16-aa26-e053-2a95a90a1b9c2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Peppermint FrostSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company42c84772-d406-b6ca-e063-6394a90a920f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Sparkle MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company42cb1b2a-55ad-cb9c-e063-6294a90ac88c2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum RecessionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company47be4eff-1ab5-17a1-e063-6394a90ae4652026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TPSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25021787-44e8-0b29-e063-6394a90a0af62026-01-08WarningsExact identifier
application number: M021
Supersmile Professional whitening TP Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2502c305-71ab-bb71-e063-6394a90a0a842026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2502840c-82ee-12cb-e063-6394a90a5b3f2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1192947Omni Just For Kids 0.4 % Oral GelPSN0f1afc36-f699-4072-b90b-c9f5be989a496
237847stannous fluoride 0.4 % Oral GelPSN0f1afc36-f699-4072-b90b-c9f5be989a496
1192947stannous fluoride 0.004 MG/MG Oral Gel [Omni Gel]SBD0f1afc36-f699-4072-b90b-c9f5be989a496
237847stannous fluoride 0.004 MG/MG Oral GelSCD0f1afc36-f699-4072-b90b-c9f5be989a496
1192947Omni Gel 0.004 MG/MG Oral GelSY0f1afc36-f699-4072-b90b-c9f5be989a496
1192947Omni Gel 0.4 % Oral GelSY0f1afc36-f699-4072-b90b-c9f5be989a496
1192947Omni Just For Kids 0.4 % Oral GelSY0f1afc36-f699-4072-b90b-c9f5be989a496
237847stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral GelSY0f1afc36-f699-4072-b90b-c9f5be989a496

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48878-4070-3488784070031 TUBE in 1 BOX (48878-4070-3) / 121.9 g in 1 TUBE1 tube1997-07-010000-00-00NoNoCurrent