FDA.reportPublic FDA data

Just For Kids

Product NDC
48878-4020
11-digit product format
488784020
Labeler code
48878
Product ID
48878-4020_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
48878-4020-3Just For Kids121.9 g in 1 TUBEGEL121.96
48878-4020-3Just For Kids1 in 1 BOXGEL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48878-4020-3GM - Gram48878-40209c8c732b-2d52-46b8-9cda-04460284ca7612012-07-24

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
48878-4020JUST 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 24 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Sensitive and Enamel ShieldSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb48b15c-f821-e5cd-e053-6294a90ac64c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Luminous PurpleSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyfbfcd837-4d88-5f82-e053-6394a90afbf62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health with a Touch of ScopeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb572b41-36cd-55d7-e053-6394a90a71c82026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Whitening GelSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb5b1e94-bed6-8486-e053-6294a90a3a842026-01-08WarningsExact identifier
application number: M021
Crest 3D White Ultra Vivid MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companycba96ef0-0519-059f-e053-2a95a90a43ad2026-01-08WarningsExact identifier
application number: M021
Crest 4in1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyce545406-3c4f-1ba7-e053-2a95a90a91ac2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd218ddc0-1d5f-f39b-e053-2995a90a96ed2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Antibacterial ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd58bc842-2687-e52d-e053-2995a90a54332026-01-08WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd65b3153-2026-a8c0-e053-2a95a90a31d62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening CharcoalSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6f68485-b92f-41c7-e053-2995a90a4fe52026-01-08WarningsExact identifier
application number: M021
KIDS Crest Advanced Enamel Plus Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd837ecde-249a-7868-e053-2a95a90a56ae2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening Intensive CleaningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6fa4187-a651-647b-e053-2995a90a85672026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Gum ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7729dde-c828-34e6-e053-2a95a90a5ee62026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd811306f-4994-7a5a-e053-2995a90adf162026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd810d4e5-ba66-efe1-e053-2995a90abfc02026-01-08WarningsExact identifier
application number: M021
Crest Braces Care Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd823cba4-c4cf-7d7a-e053-2995a90a01f02026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Sensitive ReliefSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7730674-7513-52cf-e053-2995a90ab32c2026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum FlavorSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company26a7a892-5da4-4749-bbb6-566efab7d7492026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8c91095d-88c0-4d22-a79a-7d0f0d05302b2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Deep Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd774295f-8ebd-9877-e053-2a95a90a9a0e2026-01-08WarningsExact 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
48878-4020-3488784020031 TUBE in 1 BOX (48878-4020-3) / 121.9 g in 1 TUBE1 tube1997-07-010000-00-00NoNoCurrent