FDA.reportPublic FDA data

BIS II Tooth

Product NDC
69653-200
11-digit product format
696530200
Labeler code
69653
Product ID
69653-200_49e5f925-ddd6-f7b2-e063-6394a90af28a
Type
HUMAN OTC DRUG
Nonproprietary name
Precipitated Calcium Carbonate, Tocopherol Acetate, Aluminium Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Jewoo Medical CO.,LTD
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-01-01
Substance
.ALPHA.-TOCOPHEROL ACETATE; ALCLOXA; CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Active strength
.04; .04; .1; .04 g/100g; g/100g; g/100g; g/100g
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BIS II Tooth
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE.04 g/100g
CALCIUM CARBONATE.04 g/100g
ALCLOXA.1 g/100g
.ALPHA.-TOCOPHEROL ACETATE.04 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O7TSZ97GEPInternal UNII lookup
H0G9379FGKInternal UNII lookup
18B8O9DQA2Internal UNII lookup
9E8X80D2L0Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
49e5eeaa-7506-f42a-e063-6294a90a2864Available 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
69653-200-01BIS II Tooth20 g in 1 TUBEPASTE, DENTIFRICE201

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
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49e5eeaa-7506-f42a-e063-6294a90a28642026-02-03WarningsExact identifier
ndc (product): 69653-200

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69653-200-016965302000120 g in 1 TUBE (69653-200-01) 20 g2026-01-01NoNoCurrent