FDA.reportPublic FDA data

Kids Oral Care Strawberry Flavor

Product NDC
82711-101
11-digit product format
827110101
Labeler code
82711
Product ID
82711-101_2fbc8917-44e6-67d1-e063-6294a90a5c6c
Type
HUMAN OTC DRUG
Nonproprietary name
Xylitol, Calcium Lactate
Dosage form
SPRAY
Route
DENTAL
Labeler
TOOTHFILM INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-03-13
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 Strawberry Flavor
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2URQ2N32W3Internal UNII lookup
VCQ006KQ1EInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2fbc8917-44e5-67d1-e063-6294a90a5c6cAvailable on FDA.report

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
82711-101-01Kids Oral Care Strawberry Flavor20 mg in 1 BOTTLESPRAY201
82711-101-02Kids Oral Care Strawberry Flavor1 in 1 BOXSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82711-101KIDS ORAL CARE STRAWBERRY FLAVOR (XYLITOL, CALCIUM LACTATE) SPRAY [TOOTHFILM INC.]1Current NDC, 2 package rows20250319_2fbc8917-44e5-67d1-e063-6294a90a5c6c.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids Oral Care Strawberry FlavorXYLITOL, CALCIUM LACTATETOOTHFILM INC.2fbc8917-44e5-67d1-e063-6294a90a5c6c2025-03-07WarningsExact identifier
ndc (product): 82711-101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82711-101-018271101010120 mg in 1 BOTTLE20 mgHistorical
82711-101-02827110101021 BOTTLE in 1 BOX (82711-101-02) / 20 mg in 1 BOTTLE (82711-101-01) 1 bottle2025-03-13NoNoCurrent