MULTIVITAMIN WITH FLUORIDE CHEWABLE TABLETS

Manufacturer
Sancilio & Company Inc
Effective date
2018-02-26
Label type
DIETARY SUPPLEMENT
Version
6
Source
full-release
Hydrated at
2026-06-01 02:48:51

Label at a glance#

ProductMVC
Active ingredientSodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, cyanocobalamin
Label structure13 sections

Indications and uses

Supplementation of the diet with fluoride and ten essential vitamins. Multivitamin with 1.0 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm. Multivitamin with 0.5 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the water fluoride level is less than 0.3 ppm, and f...

Dosage and administration

One tablet daily or as prescribed.

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

Rx only

STATEMENT OF IDENTITY SECTION

Nutrition Facts
Serving Size 1 Chewable Tablet
Serving Per Container 30 or 90
Amount Per Serving
(1 Chewable Tablet)
1.0 mg0.5 mg0.25 mg%DV Adults & Children
4 Years or More
Vitamin A2500 IU2500 IU2500 IU50%
Vitamin C60 mg60 mg60 mg100%
Vitamin D400 IU400 IU400 IU100%
Vitamin E15 IU15 IU15 IU50%
Thiamin1.05 mg1.05 mg1.05 mg70%
Riboflavin1.2 mg1.2 mg1.2 mg70%
Niacin13.5 mg13.5 mg13.5 mg68%
Vitamin B61.05 mg1.05 mg1.05 mg53%
Folate0.3 mg0.3 mg0.3 mg75%
Vitamin B124.5 mcg4.5 mcg4.5 mcg75%
Fluoride1.0 mg0.5 mg0.25 mg*

* Daily Value (%DV) not established

Active ingredients

HEALTH CLAIM SECTION

Fluoride as sodium fluoride.

Other Ingredients

HEALTH CLAIM SECTION

Xylitol, microcrystalline cellulose, mannitol, talc, magnesium stearate, sucralose, natural flavors, citric acid.

CLINICAL PHARMACOLOGY

HEALTH CLAIM SECTION

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Multivitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it forms to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

Chemical StructureChemical Structure

Three stages of fluoride deposition in tooth enamel can be distinguished:

  1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
  2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
  3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

INDICATIONS AND USAGE

HEALTH CLAIM SECTION

Supplementation of the diet with fluoride and ten essential vitamins.

Multivitamin with 1.0 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm.

Multivitamin with 0.5 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride.

Multivitamin with 0.25 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride.

Multivitamin with Fluoride Chewable Tablets supply significant amounts of vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.

The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

Children using Multivitamin with Fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

WARNING

WARNINGS SECTION

Keep this and all medication out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Should be chewed. This product, as with all chewable tablets, is not recommended for children under age 4 due to risk of choking.

PRECAUTIONS

PRECAUTIONS SECTION

The suggested dose of Multivitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multivitamin with Fluoride Chewable Tablets:

  1. Determine the fluoride content of the drinking water from all major sources.
  2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.
  3. Periodically check to make sure that the child does not develop significant dental fluorosis.

ADVERSE REACTIONS

HEALTH CLAIM SECTION

Allergic rash and other idiosyncrasies have been rarely reported.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

One tablet daily or as prescribed.

HOW SUPPLIED

HEALTH CLAIM SECTION

Multivitamin with 1.0 mg, 0.5 mg and 0.25 mg Fluoride Chewable Tablets are all available in 30 and 90 tablet bottles.

STORAGE

SAFE HANDLING WARNING SECTION

Store in a cool dry place. Protect from light and moisture.

HEALTH CLAIM SECTION

Manufactured by:
Sancilio & Company, Inc.
3874 Fiscal Court #200
Riviera Beach, FL 33404

PRINCIPAL DISPLAY PANEL - 1.0 mg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44946-1014-5

SCI
Sancilio & Company, Inc.

Developing Good Science into Great Medicine

MVC ™-Fluoride 1.0mg*
Multivitamin Chewable Tablets with Fluoride

No dyes, artificial flavors or sugar

Dietary
Supplement

90 tablets
Made in the U.S.A.

PRINCIPAL DISPLAY PANEL - 1.0 mg Bottle Label
PRINCIPAL DISPLAY PANEL - 1.0 mg Bottle Label

PRINCIPAL DISPLAY PANEL - 0.5mg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SCI
Sancilio & Company, Inc.

Developing Good Science into Great Medicine

44946-1013-5
Rx Only

MVC® Fluoride
0.5mg *
MULTIVITAMIN WITH FLUORIDE CHEWABLE TABLETS

NO DYES, ARTIFICIAL FLAVORS OR SUGAR
SACCHARIN AND GLUTEN FREE

MULTIVITAMIN AND FLUORIDE SUPPLEMENT

90 Tablets
Made in the U.S.A.

PRINCIPAL DISPLAY PANEL - 0.5mg Bottle Label
PRINCIPAL DISPLAY PANEL - 0.5mg Bottle Label

PRINCIPAL DISPLAY PANEL - 0.25mg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SCI
Sancilio & Company, Inc.

Developing Good Science into Great Medicine

44946-1012-5
Rx Only

MVC® Fluoride
0.25mg *
MULTIVITAMIN WITH FLUORIDE CHEWABLE TABLETS

NO DYES, ARTIFICIAL FLAVORS OR SUGAR
SACCHARIN AND GLUTEN FREE

MULTIVITAMIN AND FLUORIDE SUPPLEMENT

90 Tablets
Made in the U.S.A.

PRINCIPAL DISPLAY PANEL - 0.25mg Bottle Label
PRINCIPAL DISPLAY PANEL - 0.25mg Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1428828ascorbic acid 60 MG / cholecalciferol 0.01 MG / folic acid 0.3 MG / niacin 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / thiamine 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SBD6
1364855ascorbic acid 60 MG / cholecalciferol 0.01 MG / folic acid 0.3 MG / niacin 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / thiamine 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSCD6
1364855cyanocobalamin 4.5 MCG / folic acid 0.3 MG / niacin 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG (fluoride ion 1 MG) / thiamine 1.05 MG / vitamin A 2500 UNT / vitamin B6 1.05 MG / vitamin C 60 MG / vitamin D 400 UNT / vitamin E 15 UNT Chewable TabletSY6
1428828MVC-Fluoride (ascorbic acid 60 MG / folic Acid 0.3 MG / niacin 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG (equivalent to fluoride 1 MG) / thiamine 1.05 MG / vitamin A 2500 UNT / vitamin B 12 0.0045 MG / vitamin B6 1.05 MG / vitamin D 400 UNT / vitamin E 15 UNT) Chewable TabletSY6
1364855vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vit-B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vit-B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vit-B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vit-B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vitamin B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vitamin B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vitamin B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vit-C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vitamin B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vit-B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vit-B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vit-B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vit-B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vitamin B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vitamin B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6
1364855vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vitamin B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable TabletSY6
1428828vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vitamin B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet [MVC-Fluoride]SY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44946-1012-4MVC24 in 1 BOXTABLET, CHEWABLE246
44946-1012-4MVC4 in 1 BOXTABLET, CHEWABLE46
44946-1012-5MVC4 in 1 BOXTABLET, CHEWABLE46
44946-1012-5MVC24 in 1 BOXTABLET, CHEWABLE246
44946-1012-6MVC30 in 1 BLISTER PACKTABLET, CHEWABLE306
44946-1012-7MVC7 in 1 BOTTLE, PLASTICTABLET, CHEWABLE76
44946-1013-4MVC24 in 1 BOXTABLET, CHEWABLE246
44946-1013-4MVC4 in 1 BOXTABLET, CHEWABLE46
44946-1013-5MVC24 in 1 BOXTABLET, CHEWABLE246
44946-1013-5MVC4 in 1 BOXTABLET, CHEWABLE46
44946-1013-6MVC30 in 1 BLISTER PACKTABLET, CHEWABLE306
44946-1014-4MVC4 in 1 BOXTABLET, CHEWABLE46
44946-1014-4MVC24 in 1 BOXTABLET, CHEWABLE246
44946-1014-5MVC4 in 1 BOXTABLET, CHEWABLE46
44946-1014-5MVC24 in 1 BOXTABLET, CHEWABLE246
44946-1014-6MVC30 in 1 BLISTER PACKTABLET, CHEWABLE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44946-1012MVC (SODIUM FLUORIDE, VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID AND CYANOCOBALAMIN) TABLET, CHEWABLE [SANCILIO & COMPANY INC]66 package rows20180227_50b44fd6-8747-448f-b951-234e7e17df4f.zip
44946-1013MVC (SODIUM FLUORIDE, VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID AND CYANOCOBALAMIN) TABLET, CHEWABLE [SANCILIO & COMPANY INC]65 package rows20180227_50b44fd6-8747-448f-b951-234e7e17df4f.zip
44946-1014MVC (SODIUM FLUORIDE, VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID AND CYANOCOBALAMIN) TABLET, CHEWABLE [SANCILIO & COMPANY INC]65 package rows20180227_50b44fd6-8747-448f-b951-234e7e17df4f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44946-1014-4EA - Each44946-1014f1a89627-c4ec-4da8-9d31-2b59f5cd361512022-06-06
44946-1013-4EA - Each44946-1013221afdc1-df0c-4cc9-a696-0d198ff3d79a12022-06-06
44946-1012-4EA - Each44946-1012e1cf0ea0-c2fc-48d2-ab00-b2cf498f379812022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Alpha-Tocopherol AcetateACTIVE INGREDIENT9E8X80D2L01
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0R1
CholecalciferolACTIVE INGREDIENT1C6V77QF411
cyanocobalaminACTIVE INGREDIENTP6YC3EG2041
Folic AcidACTIVE INGREDIENT935E97BOY81
NiacinamideACTIVE INGREDIENT25X51I8RD41
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV1
RiboflavinACTIVE INGREDIENTTLM2976OFR1
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W71
Thiamine MononitrateACTIVE INGREDIENT8K0I04919X1
Vitamin A PalmitateACTIVE INGREDIENT1D1K0N0VVC1
Alpha-TocopherolACTIVE MOIETYH4N855PNZ11
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0R1
CholecalciferolACTIVE MOIETY1C6V77QF411
cyanocobalaminACTIVE MOIETYP6YC3EG2041
Fluoride IonACTIVE MOIETYQ80VPU408O1
Folic AcidACTIVE MOIETY935E97BOY81
NiacinamideACTIVE MOIETY25X51I8RD41
PyridoxineACTIVE MOIETYKV2JZ1BI6Z1
RiboflavinACTIVE MOIETYTLM2976OFR1
ThiamineACTIVE MOIETYX66NSO3N351
Vitamin A PalmitateACTIVE MOIETY1D1K0N0VVC1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61U1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP1
Magnesium StearateINACTIVE INGREDIENT70097M6I301
Malic AcidINACTIVE INGREDIENT817L1N4CKP1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD41
TalcINACTIVE INGREDIENT7SEV7J4R1U1
XylitolINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 54 matching rows.

Source Document#

Source XML · Source PDF

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 4 · 229 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Magnesium StearateMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, CHEWABLE / ORAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
Malic AcidMALIC ACID817L1N4CKPPOWDER, FOR SUSPENSION / ORAL1392 mgExact identifier — unii candidate
5 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
TalcTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
TalcTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii candidate
12 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii candidate
22 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
28 equally ranked IID candidates
Malic AcidMALIC ACID817L1N4CKPSUSPENSION / ORAL180 mgExact identifier — unii candidate
5 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii candidate
22 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EXTENDED RELEASE / ORAL45 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii candidate
12 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING / ORAL83 mgExact identifier — unii candidate
88 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e5cb08fc-008c-4cbf-82be-8a3d2612e1bd50b44fd6-8747-448f-b951-234e7e17df4f2018-02-26Warnings, Adverse reactionsExact identifier
spl set id: 50b44fd6-8747-448f-b951-234e7e17df4f

Reported adverse events (FAERS/openFDA)#

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