Multivitamin with Fluoride

Product NDC
75826-170
11-digit product format
758260170
Labeler code
75826
Product ID
75826-170_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; .5; 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
.ALPHA.-TOCOPHEROL ACETATE, DL-6.75 mg/1
ASCORBIC ACID24 mg/1
CHOLECALCIFEROL10 ug/1
CYANOCOBALAMIN4.5 ug/1
FOLIC ACID500 ug/1
NIACINAMIDE13.5 mg/1
PYRIDOXINE HYDROCHLORIDE1.05 mg/1
RIBOFLAVIN1.2 mg/1
SODIUM ASCORBATE36 mg/1
SODIUM FLUORIDE.5 mg/1
THIAMINE MONONITRATE1.05 mg/1
VITAMIN A750 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7, 1C6V77QF41, PQ6CK8PD0R, 935E97BOY8, 25X51I8RD4, WR1WPI7EW8, 81G40H8B0T, P6YC3EG204, 8K0I04919X, TLM2976OFR, S033EH8359, 68Y4CF58BV

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
75826-170-10Multivitamin with Fluoride100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-170MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [WINDER LABORATORIES, LLC]3Current NDC, 1 package rows20240214_a10ff759-eba7-414b-bb98-f17fbb6e6b57.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75826-170-1075826017010100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (75826-170-10) 2023-12-012027-06-30NoNoHistorical