FDA.reportPublic FDA data

Orajel Kids Superman

Product NDC
10237-732
11-digit product format
102370732
Labeler code
10237
Product ID
10237-732_574b93ff-4959-9da6-e063-6394a90acff7
Type
HUMAN OTC DRUG
Nonproprietary name
Anticavity Toothpaste
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-07
Substance
SODIUM FLUORIDE
Active strength
1.5 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
Orajel Kids Superman
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b47af33-32d4-7c06-e063-6394a90a2f33Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
10237-732-42Orajel Kids Superman119 g in 1 TUBEGEL, DENTIFRICE1191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-732ORAJEL KIDS SUPERMAN (ANTICAVITY TOOTHPASTE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1Current NDC, 1 package rows20250112_2b47af33-32d4-7c06-e063-6394a90a2f33.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 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro-Health Gum Rescue Pro Soothing CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f10c7ac-eb60-011e-e063-6394a90aca132026-01-08WarningsExact identifier
application number: M021
Crest Deep Cleanse Cavity DefenseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2e09cb3b-cf59-15b1-e063-6394a90a5c6a2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Maximum Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2eaeddc5-1559-9378-e063-6394a90a4ed72026-01-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Dazzling MintSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f11e935-1711-5f1a-e063-6294a90af7d82026-01-08Exact identifier
application number: M021
HEB Gleaming White Fresh MintSODIUM FLUORIDEHEB82491c8f-d2c2-2e4a-e053-2a91aa0a572f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company338acdf2-548c-0614-e063-6294a90af6352026-01-08Exact identifier
application number: M021
KIDS Crest Advanced Sugar and Bacteria ShieldSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f371af0-a2d4-25a6-e063-6394a90a923d2026-01-08WarningsExact identifier
application number: M021
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN2b47af33-32d4-7c06-e063-6394a90a2f331
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2b47af33-32d4-7c06-e063-6394a90a2f331
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2b47af33-32d4-7c06-e063-6394a90a2f331
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2b47af33-32d4-7c06-e063-6394a90a2f331
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2b47af33-32d4-7c06-e063-6394a90a2f331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-732-4210237073242119 g in 1 TUBE (10237-732-42) 119 g2025-01-07NoNoCurrent
10237-732-44102370732444 TUBE in 1 BOX (10237-732-44) / 119 g in 1 TUBE4 tube2025-08-01NoNoCurrent