Kids Oral Care Flavor Free

Product NDC
82711-106
11-digit product format
827110106
Labeler code
82711
Product ID
82711-106_3346a27c-3d4d-48a8-e063-6394a90a0ba7
Type
HUMAN OTC DRUG
Nonproprietary name
Xylitol, Calcium Lactate
Dosage form
SPRAY
Route
DENTAL
Labeler
TOOTHFILM INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-04-21
Substance
CALCIUM LACTATE; XYLITOL
Active strength
.02; 2 mg/20mg; mg/20mg
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kids Oral Care Flavor Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM LACTATE.02 mg/20mg
XYLITOL2 mg/20mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2URQ2N32W3, VCQ006KQ1E

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82711-106-01Kids Oral Care Flavor Free20 mg in 1 BOTTLESPRAY201
82711-106-02Kids Oral Care Flavor Free1 in 1 BOXSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82711-106KIDS ORAL CARE FLAVOR FREE (XYLITOL, CALCIUM LACTATE) SPRAY [TOOTHFILM INC.]1Current NDC, 2 package rows20250422_33469d77-4013-413d-e063-6294a90acbb7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82711-106-018271101060120 mg in 1 BOTTLE20 mgHistorical
82711-106-02827110106021 BOTTLE in 1 BOX (82711-106-02) / 20 mg in 1 BOTTLE (82711-106-01) 1 bottle2025-04-21NoNoHistorical