Multivitamin with Fluoride

Product NDC
58657-163
Requested package NDC
58657-163-01
11-digit product format
586570163
Labeler code
58657
Product ID
58657-163_41b5fe6c-faec-bbbb-e063-6294a90a7549
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A and VITAMIN D
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-07-20
Substance
.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D
Active strength
15; 60; 4.5; 300; 13.5; 1.05; 1.2; .25; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 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 DMethod Pharmaceuticals, LLC42ed15a5-aad6-4ab3-b95b-f9534a419f402025-10-21Warnings, Adverse reactionsExact identifier
ndc (package): 58657-163-01
ndc (product): 58657-163
ndc11 (package): 58657016301

Additional Listing Data#

Finished product
Yes
Brand name base
Multivitamin with Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VITAMIN A15 [iU]/1
ASCORBIC ACID60 mg/1
VITAMIN D4.5 ug/1
.ALPHA.-TOCOPHEROL ACETATE, DL-300 ug/1
THIAMINE MONONITRATE13.5 mg/1
RIBOFLAVIN1.05 mg/1
NIACIN1.2 mg/1
PYRIDOXINE.25 mg/1
FOLIC ACID1.05 mg/1
CYANOCOBALAMIN2500 [iU]/1
SODIUM FLUORIDE400 [iU]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81G40H8B0TInternal UNII lookup
PQ6CK8PD0RInternal UNII lookup
9VU1KI44GPInternal UNII lookup
WR1WPI7EW8Internal UNII lookup
8K0I04919XInternal UNII lookup
TLM2976OFRInternal UNII lookup
2679MF687AInternal UNII lookup
KV2JZ1BI6ZInternal UNII lookup
935E97BOY8Internal UNII lookup
P6YC3EG204Internal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
42ed15a5-aad6-4ab3-b95b-f9534a419f40Available on FDA.report

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-163-01Multivitamin with Fluoride100 in 1 BOTTLETABLET, CHEWABLE10012
58657-163-90Multivitamin with Fluoride90 in 1 BOTTLETABLET, CHEWABLE9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-163-01EA - Each58657-163cf889092-b86d-4ac6-ad05-8fcae7be460612018-11-06
58657-163-90EA - Each58657-1634979b29c-53fd-4e1c-9eec-d2f5127dbf1912018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-163MULTIVITAMIN WITH FLUORIDE (.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D) TABLET, CHEWABLE [METHOD PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 2 package rows20241126_42ed15a5-aad6-4ab3-b95b-f9534a419f40.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-163-0158657016301100 TABLET, CHEWABLE in 1 BOTTLE (58657-163-01) 2018-07-200000-00-00NoNoCurrent