FDA.reportPublic FDA data

NDC 75834-080 - Niva-Fol

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
75834-080
Package NDCs from labels
75834-080-90
Manufacturer
Nivagen Pharmaceuticals, Inc. | Natural Vitamins Laboratory Corp
Effective date
2021-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Niva-Fol - Nivagen Pharmaceuticals, Inc. | Natural Vitamins Laboratory CorpNivagen Pharmaceuticals, Inc. | Natural Vitamins Laboratory Corp2021-09-16DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-080-90Niva-Fol90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-080NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]41 package rows20210918_acd020d4-8dcf-403d-a8b4-06fb6e67d8b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-080-90EA - Each75834-080a38fc0a1-be87-46e8-9c01-cc5c4574ba3912016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CyanocobalaminACTIVE INGREDIENTP6YC3EG204NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Folic AcidACTIVE INGREDIENT935E97BOY8NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BVNIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
FOLIC ACIDACTIVE MOIETY935E97BOY8NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZNIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Calcium CarbonateINACTIVE INGREDIENTH0G9379FGKNIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
ShellacINACTIVE INGREDIENT46N107B71ONIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APNIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2

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 61 of 74 · 1,467 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mylanta Vanilla CaramelCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a66d74-74b4-3f8d-e063-6394a90a7f002024-02-05WarningsExact identifier
unii: H0G9379FGK
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.34b2924f-d220-4344-8cdd-e7dda54061c22024-02-02WarningsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.768502e2-541f-4de8-ac68-3ab47c1f436d2024-02-01WarningsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.3d5fbe3a-a95b-4688-a96e-b34e6e1e868a2024-02-01WarningsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
SiliceaSILICON DIOXIDESEVENE USA0805d866-ce1a-4f54-8a44-83d4902e8c0d2024-01-30WarningsExact identifier
unii: ETJ7Z6XBU4
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst953aa8c6-31ce-0c3b-e053-2a95a90ab35f2024-01-30Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
PYRIDOXINE HCIPYRIDOXINE HCIHF Acquisition Co LLC, DBA HealthFirst946c8e50-08d0-755d-e053-2a95a90a84de2024-01-28Warnings, Adverse reactionsExact identifier
unii: 68Y4CF58BV
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE CHEWABLE TABLETLil' Drug Store Products, Inc.d08984b8-ce03-9e95-e053-2995a90ae6f02024-01-25WarningsExact identifier
unii: H0G9379FGK
Sleep TightADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Dr. Donna Restivo DCb5955fbc-71f8-4fe0-9df0-42f337ab9c7d2024-01-18WarningsExact identifier
unii: ETJ7Z6XBU4
PNV-SelectVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDEAcella Pharmaceuticals, LLC9f4ce551-7a80-4ddb-a014-95c44b54a4202024-01-16Boxed warning, Adverse reactionsExact identifier
unii: H0G9379FGK
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
Quflora PediatricVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDECarWin Pharmaceutical Associates, LLCb8e08798-d8bb-4616-996b-a2c07a5d730a2024-01-10Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
TriStart DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, AND ICOSAPENTCarWin Pharmaceutical Associates, LLC92ccf7d4-4527-49f0-b890-1a11b5a100862024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
A05 HEAVY ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALUMINIUM METALLICUM, APIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, BELLADONNA, BERBERIS VULGARIS, CADMIUM METALLICUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, FAGUS SYLVATICA, FORMALINUM, FORMICUM ACIDUM, HYPERICUM PERFORATUM, ICHTHYOLUM, MERCURIUS CORROSIVUS, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PLUMBUM METALLICUM, SELENIUM METALLICUM, SILICEA, SOLIDAGO VIRGAUREA, STANNUM METALLICUM, THIOSINAMINUMApex Energetics Inc.b9bdc39e-8ebf-615c-e053-2a95a90afe1b2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
C08 CALCIUM METABOLISMABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN DApex Energetics Inc.bd09a34f-1615-09f0-e053-2995a90ac2ef2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
F10 WRMLVAGRIMONY, ALOE VERA, AURUM METALLICUM, AZURITE, BASIL, CALENDULA OFFICINALIS, CARICA PAPAYA, CAYENNE, DAFFODIL, DICENTRA FORMOSA, DIPLACUS AURANTIACUS, HIBISCUS CHINENSIS, HORSE CHESTNUT, HYLOTELEPHIUM TELEPHIUM, LAVANDULA STOECHAS, LILIUM TIGRINUM, MALVA NEGLECTA, MELILOTUS ALBA, NELUMBO NUCIFERA, PHOSPHORUS, PRUNELLA VULGARIS, ROSA LUCIAE, ROSEMARY, SCUTELLARIA LATERIFLORA, SEPIA, SILICEA, THUJA OCCIDENTALIS, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, YELLOW JASMINEApex Energetics Inc.bf020c17-578d-74c4-e053-2995a90a9e7d2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
N01 PROTOMERADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUMApex Energetics Inc.bfc8e049-2f62-31c4-e053-2a95a90a6e162024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
F25 LF-CHNGSAGRIMONY FLOWERApex Energetics Inc.bf3c7a21-0e4e-6395-e053-2a95a90a71562024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
R16 BRONCHIADENOSINE TRIPHOSPHATE, CALCAREA IODATA, CUPRUM METALLICUM, IGNATIA AMARA, PLATINUM METALLICUM, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.c0f759b1-d7f8-12b3-e053-2a95a90a87682024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
N09 BACTEROTOXACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.ba99bb1e-c36f-8bf8-e053-2995a90ac3082024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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