FLUORITAB CHEWABLE

Manufacturer: Fluoritab Corporation | Medical Products Laboratories
Effective date: 2012-10-29
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 20:16:12

Label at a glance#

ProductFLUORITAB CHEWABLE CHERRY

Active ingredientSODIUM FLUORIDE

Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

CONTAINS: 1.1 MG SODIUM FLUORIDE

EACH TABLET CONTAINS 0.5 MG FLUORIDE

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

WARNINGS SECTION

CAUTION: FEDERAL (U.S.A.) LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

INDICATIONS & USAGE SECTION

DIRECTIONS: ONE TABLET PER DAY, CHEWED OR PARTIALLY DISSOLVED IN MOUTH BEFORE SWALLOWING, PREFERABLY AT NIGHT AFTER BRUSHING TEETH.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: LACTOSE, FLAVOR, SACCHARIN SODIUM, MAGNESIUM STEARATE

WARNINGS AND PRECAUTIONS SECTION

PRECAUTION -RECOMMEND DOSAGE ON CHART BELOW SHOULD NOT BE EXCEEDED AS PROLONGED OVERDOSE MAY RESULT IN DENTAL FLUOROSIS.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fluoritab Chewable Cherry Tablets (0.5mg)_1000-ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
861724	Fluoritab 1.1 MG Chewable Tablet	PSN	2
313036	sodium fluoride 1.1 MG Chewable Tablet	PSN	2
861724	sodium fluoride 1.1 MG Chewable Tablet [Fluoritab]	SBD	2
313036	sodium fluoride 1.1 MG Chewable Tablet	SCD	2
861724	Fluoritab 1.1 MG (fluoride 0.5 MG) Chewable Tablet	SY	2
861724	Fluoritab 1.1 MG Chewable Tablet	SY	2
313036	sodium fluoride 1.1 MG (fluoride ion 0.5 MG) Chewable Tablet	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0288-1106-01	2019-11-27	C162847	48780-1	9855d018-e82e-cd31-e053-dbdaa90ab51a	77785440-368b-4c4f-ae52-c0384a9c3bf2
0288-1106-02	2019-11-27	C162847	48780-1	9855d018-e82e-cd31-e053-dbdaa90ab51a	77785440-368b-4c4f-ae52-c0384a9c3bf2
0288-1106-10	2019-11-27	C162847	48780-1	9855d018-e82e-cd31-e053-dbdaa90ab51a	77785440-368b-4c4f-ae52-c0384a9c3bf2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0288-1106-01	FLUORITAB CHEWABLECHERRY	100 in 1 BOTTLE	TABLET, CHEWABLE	100	2
0288-1106-02	FLUORITAB CHEWABLECHERRY	5000 in 1 BOTTLE	TABLET, CHEWABLE	5000	2
0288-1106-10	FLUORITAB CHEWABLECHERRY	1000 in 1 BOTTLE	TABLET, CHEWABLE	1000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0288-1106	FLUORITAB CHEWABLE CHERRY (SODIUM FLUORIDE) TABLET, CHEWABLE [FLUORITAB CORPORATION]	2	Legacy NDC, 3 package rows	20121029_77785440-368b-4c4f-ae52-c0384a9c3bf2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0288-1106-01	EA - Each	0288-1106	5fd36aeb-c7ce-43a5-8dd8-b8a56d8588a3	1	2013-02-13
0288-1106-02	EA - Each	0288-1106	c02f4574-2d29-4b47-a128-6d928ea1d7ba	1	2013-02-13
0288-1106-10	EA - Each	0288-1106	01dd362b-8e16-4a56-abb9-d03ce0cb1d38	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	2

Products#

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

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

FLUORITAB CHEWABLE CHERRY
SODIUM FLUORIDE
FLUORIDE ION
LACTOSE
SACCHARIN SODIUM ANHYDROUS
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0288-1106	0288-1106-01, 0288-1106-10, 0288-1106-02

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
LACTOSE	J2B2A4N98G	IACT
SACCHARIN SODIUM ANHYDROUS	I4807BK602	IACT
MAGNESIUM STEARATE	70097M6I30	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 92 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	TABLET, FILM COATED / ORAL	0.35 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	LIQUID / ORAL	1.5 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	SUSPENSION / ORAL	16.65 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	WAFER / ORAL	4.8 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	SOLUTION / NASAL	0.5 mg/1ml		Exact identifier — unii candidate 17 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	SOLUTION / RECTAL	0.67 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	INJECTION / INTRAMUSCULAR	0.09 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	POWDER, FOR SUSPENSION / ORAL	18.75 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	TABLET, CHEWABLE / ORAL	7.5 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	DROPS / NASAL	0.5 mg/1ml		Exact identifier — unii candidate 17 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUS	SACCHARIN SODIUM ANHYDROUS	I4807BK602	SYRUP / ORAL	3.96 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates

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
75d5beb2-d3d8-4e78-8df1-081095a53774			77785440-368b-4c4f-ae52-c0384a9c3bf2	2012-10-29	Warnings	Exact identifier spl id: 75d5beb2-d3d8-4e78-8df1-081095a53774 spl set id: 77785440-368b-4c4f-ae52-c0384a9c3bf2

Reported adverse events (FAERS/openFDA)#

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