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MultiVitamin with Fluoride

MultiVitamin with Fluoride Chewable Tablets

Approved
Approval ID

19b2baaa-04d5-465a-9c0c-7034117d7f16

Product Type

DIETARY SUPPLEMENT

Effective Date

Sep 16, 2025

Manufacturers
FDA

H2-Pharma, LLC

DUNS: 028473634

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, and SODIUM FLUORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61269-155
Product Classification
G
Generic Name
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, and SODIUM FLUORIDE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (19)

VITAMIN A ACETATEActive
Quantity: 750 ug in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 10 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 6.75 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM
THIAMINE MONONITRATEActive
Quantity: 1.05 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 1.2 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINAMIDEActive
Quantity: 13.5 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 1.05 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 500 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 4.5 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
SODIUM FLUORIDEActive
Quantity: 0.25 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, and SODIUM FLUORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61269-156
Product Classification
G
Generic Name
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, and SODIUM FLUORIDE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (19)

VITAMIN A ACETATEActive
Quantity: 750 ug in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 10 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 6.75 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM
THIAMINE MONONITRATEActive
Quantity: 1.05 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 1.2 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINAMIDEActive
Quantity: 13.5 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 1.05 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 500 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 4.5 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
SODIUM FLUORIDEActive
Quantity: 0.5 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, and SODIUM FLUORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61269-157
Product Classification
G
Generic Name
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, and SODIUM FLUORIDE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (19)

VITAMIN A ACETATEActive
Quantity: 750 ug in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 10 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 6.75 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM
THIAMINE MONONITRATEActive
Quantity: 1.05 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 1.2 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINAMIDEActive
Quantity: 13.5 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 1.05 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 500 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 4.5 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
SODIUM FLUORIDEActive
Quantity: 1 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/16/2025

PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label

61269-157-01

MultiVitamin
with Fluoride
Chewable Tablets

1 mg

MultiVitamin and Fluoride Supplement

Dietary Supplement
Orange Flavor

100 Tablets

H2 pharma

PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/16/2025

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

STATEMENT OF IDENTITY SECTION

LOINC: 69718-5Updated: 9/16/2025

Supplement Facts

Serving Size 1 Tablet

Servings Per Container 100

Amount Per Serving

% Daily Value

  • Daily Value not established

Vitamin A

750 mcg (2500 IU)

83%

Vitamin C

60 mg

67%

Vitamin D

10 mcg (400 IU)

50%

Vitamin E

6.75 mg (15 IU)

45%

Thiamine

1.05 mg

88%

Riboflavin

1.2 mg

92%

Niacinamide

13.5 mg

84%

Vitamin B6

1.05 mg

62%

Folate (Folic Acid)

500 mcg DFE (0.3 mg)

125%

Vitamin B12

4.5 mcg

188%

Fluoride

0.25 mg

WARNINGS SECTION

LOINC: 34071-1Updated: 9/16/2025

WARNINGS

AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN. This tablet should be chewed. This product, as with all chewable tablets, are not recommended for children under the age of 4 due to risk of choking.

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 9/16/2025

Distributed by:
H2-Pharma, LLC
Montgomery, AL 36117

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 9/16/2025

PRECAUTIONS

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

Before recommendingMultiVitamin 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.

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MultiVitamin with Fluoride - FDA Drug Approval Details