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 51 of 74 · 1,467 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive Regular Strength Antacid PeppermintCALCIUM CARBONATEStrategic Sourcing Services LLC49d1b6c4-432b-44d3-b073-0185dbed7a902024-12-12WarningsExact identifier
unii: H0G9379FGK
Mylanta New Tonight Soothing Honey ChamomileCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.123f3005-a0a0-4970-94f1-f6d04741078b2024-12-11WarningsExact identifier
unii: H0G9379FGK
Topcare Ultra Strength Antacid PeppermintCALCIUM CARBONATETopco Associates, LLCfb434059-7b6e-42e0-acfa-db9879f6a4e42024-12-11WarningsExact identifier
unii: H0G9379FGK
TopCare Ultra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates, LLCdd038b15-2ecb-4ee2-b356-db6d87c2f01b2024-12-11WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Smooth Dissolve Assorted FruitCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1b6a48a7-0703-2d3d-e063-6394a90a46412024-12-11WarningsExact identifier
unii: H0G9379FGK
Careone Regular Strength Calcium AntacidCALCIUM CARBONATERetail Business Services, LLC.bdd9a64d-777b-45e0-8a9a-6cdc54baf8982024-12-11WarningsExact identifier
unii: H0G9379FGK
Careone Regular Strength calcium AntacidCALCIUM CARBONATERetail Business Services, LLC.cb6e12cc-4b88-4046-a9fc-2dbe4bca965e2024-12-11WarningsExact identifier
unii: H0G9379FGK
TopCare Ultra Strength Antacid Assorted BerryCALCIUM CARBONATETopco Associates, LLCc10c56ba-51cf-47f9-80a8-aa188859608f2024-12-11WarningsExact identifier
unii: H0G9379FGK
TopCare Extra Strength Antacid Extra Strength Antacid Assorted BerryCALCIUM CARBONATETopco Associates, LLC0aefbd70-4103-410c-83b2-f7baa0b80ddd2024-12-09WarningsExact identifier
unii: H0G9379FGK
Topcare Extra Strength Antacid Assorted Fruit Extra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates, LLC563a9951-0d40-448b-bf0d-8f6d905087d02024-12-09WarningsExact identifier
unii: H0G9379FGK
TUMS EXCALCIUM CARBONATEHaleon US Holdings LLC593a0494-d669-4bcf-8412-b92645b2d76c2024-12-05WarningsExact identifier
unii: H0G9379FGK
VentrixylFOLIC ACIDPureTek Corporationc29dc729-93be-2a20-e053-2a95a90a8ca32024-12-03Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
FOLIC ACIDFOLIC ACIDSUNRISE PHARMACEUTICAL, INC.6854412b-7ecb-4107-85eb-730f14e23f062024-12-03Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Folitin-ZFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb141ac2-e5df-4df4-e053-2995a90a6e722024-12-02Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
GeovitaCEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEARUBIMED AG0fcb5c06-d414-456c-a0ef-28e14018a7812024-11-29WarningsExact identifier
unii: ETJ7Z6XBU4
Davimet with IronIRON, FOLATEPureTek Corporation1445921b-5bf4-ea48-e063-6294a90abb1a2024-11-27Warnings, Adverse reactionsExact identifier
unii: 68Y4CF58BV
FoliflexFERROUS FUMARATE, FOLIC ACIDPureTek Corporationcba98d1a-8cf9-39d9-e053-2995a90ae8bb2024-11-27Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d4ddaf-9c07-a7fc-e063-6394a90adc0b2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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