Label at a glance#

ProductO Bits Xylitol Toothpaste Yuja Mint Flavor

Active ingredientSodium Fluoride

Label structure10 sections

Indications and uses

■ Helps protect against cavities, plaque, and gingivitis.

Dosage and administration

■ Adults and children 6 years of age and older: Chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22%(1,000 ppm fluoride ion)

PURPOSE

OTC - PURPOSE SECTION

Anti-cavity

Uses

INDICATIONS & USAGE SECTION

■ Helps protect against cavities, plaque, and gingivitis.

Warnings

WARNINGS SECTION

Please keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children under 6 years of age

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 6 years of age and older: Chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Other Information

OTHER SAFETY INFORMATION

■ Store at 33.8-86℉(1-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D-Sorbitol, Xylitol(50,000 ppm), Silicon Dioxide, Sodium Cocoyl Glutamate, Microcrystalline Cellulose, Xanthan Gum, Tetrasodium Pyrophosphate, Sodium Bicarbonate, Magnesium Stearate, Combined Flavor(Strongmint Flavor), Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Spearmint Flavor Powder), Hydroxypropylcellulose, Gardenia Yellow, Gardenia Blue, Enzymatically Modified Stevia, Bamboo Salt, Yuja Extract, Sage Extract, Pyridoxine Hydrochloride, L-Menthol

O-Bits Xylitol Toothpaste Yuja Mint Flavor (30 tablets)NDC: 82989-020-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cello pack

O-Bits Xylitol Toothpaste Yuja Mint Flavor (180 tablets)NDC: 82989-020-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cello pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	2
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	2
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82989-020-01	2024-01-30	C162847	48780-1	0191ceaa-647f-198a-e063-dbdaa90aec3e	cb4b3ffa-4e9c-4fe5-ac2c-edbbcf24dbb0
82989-020-02	2024-01-30	C162847	48780-1	0191ceaa-647f-198a-e063-dbdaa90aec3e	cb4b3ffa-4e9c-4fe5-ac2c-edbbcf24dbb0
82989-020-01	2023-12-28	C162847	48780-1	0191ceaa-647f-198a-e063-dbdaa90aec3e	cb4b3ffa-4e9c-4fe5-ac2c-edbbcf24dbb0
82989-020-02	2023-12-28	C162847	48780-1	0191ceaa-647f-198a-e063-dbdaa90aec3e	cb4b3ffa-4e9c-4fe5-ac2c-edbbcf24dbb0
82989-020-01	2023-07-28	C162847	48780-1	0191ceaa-647f-198a-e063-dbdaa90aec3e	cb4b3ffa-4e9c-4fe5-ac2c-edbbcf24dbb0
82989-020-02	2023-07-28	C162847	48780-1	0191ceaa-647f-198a-e063-dbdaa90aec3e	cb4b3ffa-4e9c-4fe5-ac2c-edbbcf24dbb0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82989-020-01	O Bits Xylitol Toothpaste Yuja Mint Flavor	30 in 1 CELLO PACK	PASTE, DENTIFRICE	30		2
82989-020-02	O Bits Xylitol Toothpaste Yuja Mint Flavor	180 in 1 CELLO PACK	PASTE, DENTIFRICE	180		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82989-020	O BITS XYLITOL TOOTHPASTE YUJA MINT FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROJECT NOAH INC.]	2	Legacy NDC, 2 package rows	20220927_cb4b3ffa-4e9c-4fe5-ac2c-edbbcf24dbb0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

O Bits Xylitol Toothpaste Yuja Mint Flavor
Sodium Fluoride
FLUORIDE ION
SORBITOL
Xylitol
Silicon Dioxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82989-020	82989-020-01, 82989-020-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Fluoride	8ZYQ1474W7	ACTIM
SORBITOL	506T60A25R	IACT
Xylitol	VCQ006KQ1E	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ad0cec91-cc1d-4cc2-8118-d05c3434326d			cb4b3ffa-4e9c-4fe5-ac2c-edbbcf24dbb0	2022-09-23	Warnings	Exact identifier spl id: ad0cec91-cc1d-4cc2-8118-d05c3434326d spl set id: cb4b3ffa-4e9c-4fe5-ac2c-edbbcf24dbb0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.