Tri-Vitamin Drops with Fluoride

Manufacturer: Sancilio & Company Inc
Effective date: 2018-03-06
Label type: DIETARY SUPPLEMENT
Version: 5
Source: full-release
Hydrated at: 2026-06-01 02:48:54

Label at a glance#

ProductTri-Vitamin with Fluoride

Active ingredientVitamin A, Ascorbic Acid, Vitamin D, Sodium Fluoride

Label structure6 sections

Dosage and administration

Use as directed by a physician. Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper. Do not accept if tamper evident box seal is broken or missing.

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Ingredients

STATEMENT OF IDENTITY SECTION

Vitamin A	1500 IU
Vitamin C	35 mg
Vitamin D	400 IU
Fluoride^* (as Sodium Fluoride)	0.25 mg

* Each 1 mL of Tri-Vitamin Drops contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride (NaF).

Other Ingredients:

HEALTH CLAIM SECTION

Glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color, propyl paraben.

Storage

SAFE HANDLING WARNING SECTION

Store in a cool, dry place at room temperature 20°-25°C (68°-77°F) away from heat and sunlight. Store in original container.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222.

Caution

PRECAUTIONS SECTION

Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives) since these may decrease effectiveness.

Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis.

This medical food product is formulated to be administered orally, under the supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation. This product is a medical food and is not intended to be used as a drug or dietary supplement.

The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

SHAKE WELL BEFORE USING

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Use as directed by a physician.

How to Use

HEALTH CLAIM SECTION

Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper.

Do not accept if tamper evident box seal is broken or missing.

HEALTH CLAIM SECTION

Manufactured by: Sancilio & Co., Inc. Riviera Beach, FL 33404 USA

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44946-1035-8

SCI
Sancilio &
Company, Inc.
Developing Good Science into Great Medicine

Tri-Vitamin Drops
with Fluoride

VITAMINS A, C, D & FLUORIDE DROPS

NO DYES OR SUGAR
SACCHARIN AND GLUTEN FREE

0.25
mg/mL

1⅔ FL. OZ. (50 mL)

Dispense under a
physician's order^†

Dietary
Supplement

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1365980	Ascorbic acid/Cholecalciferol/Sodium fluoride/Vitamin A (Oral Liquid)	ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution	SCD Active
1365984	Ascorbic acid/Cholecalciferol/Sodium fluoride/Vitamin A (Oral Liquid)	ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1365980	vitamin C 35 MG/mL / cholecalciferol 0.01 MG/mL / sodium fluoride 0.55 MG/mL / vitamin A palmitate 450 MCG/mL Oral Solution	PSN	5
1365980	ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution	SCD	5
1365980	sodium fluoride 0.55 MG (fluoride ion 0.25 MG) / vitamin A palmitate 450 MCG (1500 UNT) / vitamin C 35 MG / vitamin D3 10 MCG (400 UNT) per ML Oral Solution	SY	5
1365980	vit-C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution	SY	5
1365980	vitamin C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ASCORBIC ACID Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
VITAMIN A Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44946-1035-8	Tri-Vitamin with Fluoride	50 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	50		5
44946-1035-8	Tri-Vitamin with Fluoride	1 in 1 CARTON	SOLUTION/ DROPS	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44946-1035	TRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]	5	2 package rows	20180329_22a4dc9a-4963-4def-a4ac-2c40dbcbeb82.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44946-1035-8	ML - Milliliter	44946-1035	b6f7edd1-4405-4dee-9dee-295d7272ef3e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ascorbic Acid	ACTIVE INGREDIENT	PQ6CK8PD0R	2
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	2
Vitamin A	ACTIVE INGREDIENT	81G40H8B0T	2
Vitamin D	ACTIVE INGREDIENT	9VU1KI44GP	2
Ascorbic Acid	ACTIVE MOIETY	PQ6CK8PD0R	2
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	2
Vitamin A	ACTIVE MOIETY	81G40H8B0T	2
Vitamin D	ACTIVE MOIETY	9VU1KI44GP	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	2
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	2
Propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	2
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	2
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Tri-Vitamin with Fluoride
Vitamin A, Ascorbic Acid, Vitamin D, and Sodium Fluoride
Vitamin A
Ascorbic Acid
Vitamin D
Sodium Fluoride
Fluoride Ion
Glycerin
Water
Polysorbate 80
Sodium hydroxide
Propylene glycol
Sucralose
Methylparaben
Propylparaben

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
44946-1035	44946-1035-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Vitamin A	81G40H8B0T	ACTIB
Ascorbic Acid	PQ6CK8PD0R	ACTIB
Vitamin D	9VU1KI44GP	ACTIB
Sodium Fluoride	8ZYQ1474W7	ACTIM
Glycerin	PDC6A3C0OX	IACT
Water	059QF0KO0R	IACT
Polysorbate 80	6OZP39ZG8H	IACT
Sodium hydroxide	55X04QC32I	IACT
Propylene glycol	6DC9Q167V3	IACT
Sucralose	96K6UQ3ZD4	IACT
Methylparaben	A2I8C7HI9T	IACT
Propylparaben	Z8IX2SC1OH	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 10 · 577 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVESICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, EXTENDED RELEASE / ORAL		13 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SYRUP / ORAL	71 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / ORAL	2 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / NASAL	20 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCONJUNCTIVAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	EMULSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		27 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	DISC / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LOTION, AUGMENTED / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	ENEMA / RECTAL	0.01 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 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
87fe550e-8ce4-42c1-8a99-99f37fed745a			22a4dc9a-4963-4def-a4ac-2c40dbcbeb82	2018-03-06		Exact identifier spl set id: 22a4dc9a-4963-4def-a4ac-2c40dbcbeb82

Reported adverse events (FAERS/openFDA)#

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

Tri-Vitamin Drops with Fluoride

Label at a glance#

Dosage and administration

Contacts and useful links#

Label contents#

Full prescribing information#

Ingredients

Other Ingredients:

Storage

Caution

DIRECTIONS

How to Use

HEALTH CLAIM SECTION

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#