Multivitamin with Fluoride

Product NDC
75826-169
11-digit product format
758260169
Labeler code
75826
Product ID
75826-169_3d5c9b5b-6c7f-73c9-e063-6294a90a42b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
WINDER LABORATORIES, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-01
Marketing end
2027-06-30
Substance
.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A
Active strength
6.75; 24; 10; 4.5; 500; 13.5; 1.05; 1.2; 36; .25; 1.05; 750 mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [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], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Multivitamin with Fluoride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE6.75 mg/1
VITAMIN A24 mg/1
ASCORBIC ACID10 ug/1
SODIUM ASCORBATE4.5 ug/1
CHOLECALCIFEROL500 ug/1
.ALPHA.-TOCOPHEROL ACETATE, DL-13.5 mg/1
THIAMINE MONONITRATE1.05 mg/1
RIBOFLAVIN1.2 mg/1
NIACINAMIDE36 mg/1
PYRIDOXINE HYDROCHLORIDE.25 mg/1
FOLIC ACID1.05 mg/1
CYANOCOBALAMIN750 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S033EH8359Internal UNII lookup
1C6V77QF41Internal UNII lookup
P6YC3EG204Internal UNII lookup
25X51I8RD4Internal UNII lookup
68Y4CF58BVInternal UNII lookup
TLM2976OFRInternal UNII lookup
PQ6CK8PD0RInternal UNII lookup
81G40H8B0TInternal UNII lookup
WR1WPI7EW8Internal UNII lookup
8K0I04919XInternal UNII lookup
935E97BOY8Internal 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
a10ff759-eba7-414b-bb98-f17fbb6e6b57Available 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
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
75826-169-10Multivitamin with Fluoride100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-169MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [WINDER LABORATORIES, LLC]3Current NDC, 1 package rows20240214_a10ff759-eba7-414b-bb98-f17fbb6e6b57.zip

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
Multivitamin with FluorideSODIUM FLUORIDEWINDER LABORATORIES, LLCa10ff759-eba7-414b-bb98-f17fbb6e6b572025-08-27Warnings, Adverse reactionsExact identifier
ndc (product): 75826-169

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75826-169-1075826016910100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (75826-169-10) 2024-02-012027-06-30NoNoHistorical