FDA.reportPublic FDA data

Multivitamin-05mg-tablets

Manufacturer
Neos Therapeutics, LP
Effective date
2023-06-30
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:50

Label at a glance#

ProductMultivitamin with Fluoride
Active ingredientVITAMIN A ACETATE, SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, SODIUM FLUORIDE
Label structure6 sections

Dosage and administration

Caution:  This product should be chewed and is not recommended for children under age 4 due to risk of choking. Dispense under a physician's order

Label contents#

Full prescribing information#

Multivitamin with Fluoride

STATEMENT OF IDENTITY SECTION

Multivitamin with 0.5 mg of Fluoride Chewable Tablet

Health Claim

HEALTH CLAIM SECTION

Supplement Fact
Serving Size 1 Tablet
Servings Per Container 30
Amount Per Serving % Daily Value
 for Adults and Children
 4 or More Years of Age
Vitamin A (as retinyl acetate) 600 mcg67%
Vitamin C (as sodium ascorbate)60 mg67%
Vitamin D (as cholecalciferol)10 mcg50%
Vitamin E (as d-alpha-tocopherol)10 mg67%
Thiamin (as thiamin mononitrate)1 mg83%
Riboflavin1.2 mg92%
Niacin (as niacinamide)10 mg63%
Vitamin B6 (as pyridoxine HCl)1 mg59%
Folate (as Metafolin®)200 mcg DFE50%
Vitamin B12 (as cyanocobalamin)4.5 mcg188%
Fluoride (as sodium fluoride)0.5 mg*
*DailyValue not established

Warnings

WARNINGS SECTION

Allergen Warning: Contains fish gelatin and soy oil.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Caution: This product should be chewed and is not recommended for children under age 4 due to risk of choking.

Dispense under a physician's order

Safe Handling Warning

SAFE HANDLING WARNING SECTION

Metafolin® is a registered trademark of Merck KGaA, Darmstadt, Germany

Distributed by:
NeosTherapeutics
2940 N. Highway 360
Grand Prairie, TX 75050
www.neostx.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62542-300-30

Multivitamin with Fluoride

(Multivitamin with 0.5 mg of Fluoride) Chewable Tablet

BERRY FLAVOR

0.5 mg

30 Tablets

CONTAINS:METAFOLIN®

NEOS THERAPEUTICS

Dispense under a physician's order

Multivitamin with 0.5 mg of Fluoride
Multivitamin with 0.5 mg of Fluoride

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
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
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
62542-300-30Multivitamin with Fluoride1 in 1 PACKAGETABLET, CHEWABLE11
62542-300-30Multivitamin with Fluoride30 in 1 BOTTLETABLET, CHEWABLE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62542-300MULTIVITAMIN WITH FLUORIDE (MULTIVITAMIN WITH 0.5 MG OF FLUORIDE) TABLET, CHEWABLE [NEOS THERAPEUTICS, LP]12 package rows20230702_d7f78e41-7fe2-4be0-bfba-1744e669d87d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62542-300-30EA - Each62542-3002726204e-2a61-443b-8eaa-e328ba698cb612023-08-08

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62542-30062542-300-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A ACETATE3LE3D9D6OYACTIM
SODIUM ASCORBATES033EH8359ACTIM
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL, D-N9PR3490H9ACTIB
THIAMINE MONONITRATE8K0I04919XACTIR
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
LEVOMEFOLATE CALCIUMA9R10K3F2FACTIM
CYANOCOBALAMINP6YC3EG204ACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SUCROSEC151H8M554IACT
SORBITOL506T60A25RIACT
FRUCTOSE6YSS42VSEVIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CARRAGEENAN5C69YCD2YJIACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
SUCRALOSE96K6UQ3ZD4IACT

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack696cb342-fc5c-47cf-bbc8-5ecc706074c02026-03-27Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack0800f4ef-1d98-4c0f-a016-501791973f662026-03-27Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack0f11c8c7-c73e-4610-83ed-e697539ac1802026-03-27Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackf28c8928-81c3-458a-9ce2-2aaca3b7527d2026-03-18Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackef79cadb-c553-4af1-9a53-6ea1ab26b4bb2026-03-18Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack6607fcec-2da9-47df-ad92-1d545f7bf5352026-03-17Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack3c3acbdd-0bcb-4798-b6c5-242bdcd352b12026-03-17Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack5568579f-3445-4f04-a936-33c78b33392c2026-03-17Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackb7f1c321-5a00-4b89-8cb4-fa250e74d9db2026-03-17Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC42ed15a5-aad6-4ab3-b95b-f9534a419f402025-10-21Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC71698332-4ab1-4cbb-a98d-1694b715924b2025-10-21Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLCa5af0d8e-5d83-40bb-8df5-3af7277d72cf2025-10-21Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with FluorideSODIUM FLUORIDEWINDER LABORATORIES, LLCa10ff759-eba7-414b-bb98-f17fbb6e6b572025-08-27Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride

Reported adverse events (FAERS/openFDA)#

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