FDA.reportPublic FDA data

Gel 1100

Product NDC
61578-213
11-digit product format
615780213
Labeler code
61578
Product ID
61578-213_8c79367f-d60d-484b-8e32-87de7cf75358
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Dental Alliance Holdings LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-10
Substance
SODIUM FLUORIDE
Active strength
1100 ug/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gel 1100
Brand name suffix
Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1100 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61578-213-012024-01-31C16284748780-11030e365-0ce9-111a-e063-dadaa90a10e2Gel 1100
61578-213-012024-01-30C16284748780-11030e365-0ce9-111a-e063-dadaa90a10e2Gel 1100

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61578-213-01Gel 1100Mint68 g in 1 TUBE, WITH APPLICATORGEL, DENTIFRICE683
61578-213-02Gel 1100Mint24.1 g in 1 TUBE, WITH APPLICATORGEL, DENTIFRICE24.13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61578-213GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [DENTAL ALLIANCE HOLDINGS LLC]2Current NDC, Legacy NDC, 2 package rows20240202_f125fb04-5045-5367-e053-2a95a90aa73b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNf125fb04-5045-5367-e053-2a95a90aa73b3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDf125fb04-5045-5367-e053-2a95a90aa73b3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYf125fb04-5045-5367-e053-2a95a90aa73b3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYf125fb04-5045-5367-e053-2a95a90aa73b3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYf125fb04-5045-5367-e053-2a95a90aa73b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61578-213-016157802130168 g in 1 TUBE, WITH APPLICATOR (61578-213-01) 68 g2022-05-100000-00-00NoNoCurrent
61578-213-026157802130224.1 g in 1 TUBE, WITH APPLICATOR (61578-213-02) 24.1 g2025-11-01YesNoHistorical