FDA.reportPublic FDA data

Dotremin

Product NDC
59088-524
Requested package NDC
59088-524-54
11-digit product format
590880524
Labeler code
59088
Product ID
59088-524_d5922f8a-7f55-7e96-e053-2a95a90a70a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Folic Acid, Vitamin D3
Dosage form
TABLET
Route
ORAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-01-14
Substance
FOLIC ACID; VITAMIN D
Active strength
1; 250 mg/1; ug/1
Pharmacologic classes
Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Dotremin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOLIC ACID1 mg/1
VITAMIN D250 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
935E97BOY8Internal UNII lookup
9VU1KI44GPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2569082Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cd132db2-7ff7-a9eb-e053-2995a90a02c5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-524-54Dotremin30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-524-54EA - Each59088-52463e156a4-4ddc-40fa-8a52-d980d4d24ef912022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-524DOTREMIN (FOLIC ACID, VITAMIN D3) TABLET [PURETEK CORPORATION]3Current NDC, Legacy NDC, 1 package rows20220115_cd132db2-7ff7-a9eb-e053-2995a90a02c5.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
DotreminFOLIC ACID, VITAMIN D3PureTek Corporationcd132db2-7ff7-a9eb-e053-2995a90a02c52022-01-14Warnings, Adverse reactionsExact identifier
ndc (package): 59088-524-54
ndc (product): 59088-524
ndc11 (package): 59088052454

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2569082vitamin D3 250 MCG (10,000 UNT) / folate 1700 MCG DFE (1000 mcg folic acid) Oral TabletPSNcd132db2-7ff7-a9eb-e053-2995a90a02c53
2569082cholecalciferol 0.25 MG / folic acid 1 MG Oral TabletSCDcd132db2-7ff7-a9eb-e053-2995a90a02c53
2569082cholecalciferol 0.25 MG / folate 1 MG Oral TabletSYcd132db2-7ff7-a9eb-e053-2995a90a02c53
2569082vitamin D3 250 MCG (10,000 UNT) / folate 1700 MCG DFE (1000 mcg folic acid) Oral TabletSYcd132db2-7ff7-a9eb-e053-2995a90a02c53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-524-545908805245430 TABLET in 1 BOTTLE, PLASTIC (59088-524-54) 30 tablet2022-01-140000-00-00NoNoCurrent