FDA.reportPublic FDA data

Multi-Vitamin Fluoride Drops

Product NDC
52959-593
11-digit product format
529590593
Labeler code
52959
Product ID
52959-593_360650e7-757b-462f-8518-ffc103c71bc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B12, Niacin, Vitamin B6, Flouride
Dosage form
SOLUTION
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-05-04
Marketing end
0000-00-00
Substance
VITAMIN A; THIAMINE; RIBOFLAVIN; ASCORBIC ACID; CHOLECALCIFEROL; NIACIN; PYRIDOXINE; CYANOCOBALAMIN; FLUORIDE ION; .ALPHA.-TOCOPHEROL SUCCINATE, D-
Active strength
1500 [iU]/mL; mg/mL; mg/mL; mg/mL; [iU]/mL; mg/mL; mg/mL; ug/mL; mg/mL; [iU]/mL
Pharmacologic classes
Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-593-502019-11-13C16284748780-197449f38-b6c9-f6ea-e053-dbdaa90aa703Unknown Title

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-593-50Multi-Vitamin Fluoride Drops50 mL in 1 BOTTLE, DROPPERSOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-593-50ML - Milliliter52959-5932f85be69-6523-4eb5-b323-20a21b7de7e512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.ALPHA.-TOCOPHEROL SUCCINATE, D-ACTIVE INGREDIENTLU4B53JYVEMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0RMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF41MULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204MULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
FLUORIDE IONACTIVE INGREDIENTQ80VPU408OMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
NIACINACTIVE INGREDIENT2679MF687AMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
PYRIDOXINEACTIVE INGREDIENTKV2JZ1BI6ZMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFRMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
THIAMINEACTIVE INGREDIENTX66NSO3N35MULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
VITAMIN AACTIVE INGREDIENT81G40H8B0TMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
.ALPHA.-TOCOPHEROL SUCCINATE, D-ACTIVE MOIETYLU4B53JYVEMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0RMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF41MULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204MULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
NIACINACTIVE MOIETY2679MF687AMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
RIBOFLAVINACTIVE MOIETYTLM2976OFRMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
THIAMINEACTIVE MOIETYX66NSO3N35MULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
VITAMIN AACTIVE MOIETY81G40H8B0TMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
CHERRYINACTIVE INGREDIENTBUC5I9595WMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
FERROUS SULFATEINACTIVE INGREDIENT39R4TAN1VTMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-593MULTI-VITAMIN FLUORIDE DROPS (VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B1, VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE) SOLUTION [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20111209_4cf69ae7-0c43-4752-b58c-a2052e39b3fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234482ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / niacin 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / thiamine 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSCD4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482ascorbic acid 35 MG / cholecalciferol 400 UNT / niacin 8 MG / riboflavin 0.6 MG / sodium fluoride 0.55 MG (fluoride 0.25 MG) / thiamine 0.5 MG / vitamin A 1500 UNT / vitamin B 12 2 MCG / vitamin B6 0.4 MG / vitamin E 5 UNT per ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY4cf69ae7-0c43-4752-b58c-a2052e39b3fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-593-505295905935050 mL in 1 BOTTLE, DROPPER50 mlHistorical