FDA.reportPublic FDA data

PNV Prenatol

Product NDC
59088-078
Requested package NDC
59088-078-54
11-digit product format
590880078
Labeler code
59088
Product ID
59088-078_583f00c7-1e74-9db6-e063-6294a90a684c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Multivitamin
Dosage form
TABLET
Route
ORAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-08-21
Substance
RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; .ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; CHOLINE BITARTRATE; FERROUS FUMARATE; POTASSIUM IODIDE
Active strength
3.4; 20; 120; 1000; 10; 200; 1500; 3; 25; 2.6; 30; 200; 45; 50; 50; 70; 20; 55; 27; 150 mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], 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 D [CS], Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
PNV Prenatol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIBOFLAVIN3.4 mg/1
NIACINAMIDE20 mg/1
ASCORBIC ACID120 mg/1
LEVOMEFOLATE CALCIUM1000 ug/1
CYANOCOBALAMIN10 ug/1
CALCIUM CARBONATE200 mg/1
VITAMIN A ACETATE1500 ug/1
THIAMINE MONONITRATE3 mg/1
ZINC OXIDE25 mg/1
MANGANESE SULFATE2.6 mg/1
.ALPHA.-TOCOPHEROL ACETATE, DL-30 mg/1
MAGNESIUM OXIDE200 mg/1
CHROMIUM NICOTINATE45 ug/1
PYRIDOXINE HYDROCHLORIDE50 mg/1
MOLYBDENUM50 ug/1
SELENIUM70 ug/1
CHOLECALCIFEROL20 ug/1
CHOLINE BITARTRATE55 mg/1
FERROUS FUMARATE27 mg/1
POTASSIUM IODIDE150 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TLM2976OFRInternal UNII lookup
25X51I8RD4Internal UNII lookup
PQ6CK8PD0RInternal UNII lookup
A9R10K3F2FInternal UNII lookup
P6YC3EG204Internal UNII lookup
H0G9379FGKInternal UNII lookup
3LE3D9D6OYInternal UNII lookup
8K0I04919XInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
W00LYS4T26Internal UNII lookup
WR1WPI7EW8Internal UNII lookup
3A3U0GI71GInternal UNII lookup
A150AY412VInternal UNII lookup
68Y4CF58BVInternal UNII lookup
81AH48963UInternal UNII lookup
H6241UJ22BInternal UNII lookup
1C6V77QF41Internal UNII lookup
6K2W7T9V6YInternal UNII lookup
R5L488RY0QInternal UNII lookup
1C4QK22F9JInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
583f0194-0306-f31b-e063-6394a90a2a10Available on FDA.report

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
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
ndc (package): 59088-078-54
ndc (product): 59088-078
ndc11 (package): 59088007854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-078-545908800785430 TABLET in 1 BOTTLE, PLASTIC (59088-078-54) 30 tablet2026-08-21NoNoCurrent