FDA.reportPublic FDA data

NDC 61269-161 - MultiVitamin with Fluoride Drops

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
61269-161
Package NDCs from labels
61269-161-50
Manufacturer
H2-Pharma, LLC
Effective date
2025-09-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MultiVitamin with Fluoride Drops - H2-Pharma, LLCH2-Pharma, LLC2025-09-15DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-161-50MultiVitamin with Fluoride Drops50 mL in 1 BOTTLESOLUTION/ DROPS504
61269-161-50MultiVitamin with Fluoride Drops1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-161MULTIVITAMIN WITH FLUORIDE DROPS (VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, AND SODIUM FLUORIDE) SOLUTION/ DROPS [H2-PHARMA, LLC]32 package rows20220915_cbcc97c9-c526-4710-95ed-c72d54ab6250.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-161-50ML - Milliliter61269-16126e86acd-4613-428c-b98d-a2087086298812017-04-05

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 93 of 96 · 1,911 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Fluoride 5000 ppm Enamel ProtectSODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%Sheffield Pharmaceuticals LLC83dfdead-4f71-404e-90ae-dbd6849c7cf12021-01-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9a61f1ae-d3a4-68d7-e053-2a95a90a43332020-12-03WarningsExact identifier
unii: PQ6CK8PD0R
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9aefc830-329c-5e35-e053-2a95a90a6ffe2020-11-30WarningsExact identifier
unii: PQ6CK8PD0R
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9af2d6f4-baa8-5da9-e053-2995a90a3dac2020-11-30WarningsExact identifier
unii: PQ6CK8PD0R
Ionite APF NeutralSODIUM FLUORIDEDharma Research, inc.ad7a660b-274c-417e-bdf3-1d5addf06ad12020-11-18WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.8ff1b377-0535-4548-a109-f9f1a43b85b72020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.e6c31330-43e0-4d32-af54-ff852af39cab2020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.bc9664df-c4eb-4d29-b1c0-4d4dff6a75e42020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.b8b7f9b8-ff11-4a76-ab36-7822c15e18922020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.e1797adf-4665-4322-a3aa-dd2da9dcd3a82020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.ce34c159-34cd-47c7-937f-743b3309742b2020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.503ca71a-f50c-4406-b925-5b6ac36a92122020-11-15WarningsExact identifier
unii: 8ZYQ1474W7
Ionite RSODIUM FLUORIDEDharma Research, Inc.1009afc7-6e9d-417f-a702-f8a941e084842020-11-06Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite RSODIUM FLUORIDEDharma Research, Inc.0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a52020-11-06Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite APF FoamSODIUM FLUORIDEDharma Research, inc.d22afac7-45d6-467e-951a-e7c241b9180d2020-10-27WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APF FoamSODIUM FLUORIDEDharma Research, inc.4828b482-486f-4105-bed0-3fe2ddbbddb12020-10-27WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APF FoamSODIUM FLUORIDEDharma Research, Inc.8987b447-3fa3-4f52-aecc-80e44c981aaa2020-10-27WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APF NeutralSODIUM FLUORIDEDharma Research, inc.8191554f-adb6-4ba9-aa80-0a9bb65193ec2020-10-27WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APF FoamSODIUM FLUORIDEDharma Research, inc.ddd34623-cb79-4fa7-bd01-19122470b63d2020-10-27WarningsExact identifier
unii: 8ZYQ1474W7
GUNA ARTHRO RELIEFARTERIA SUIS - ALPHA KETOGLUTARICUM ACIDUM - ALPHA LIPOICUM ACIDUM - ASCORBICUM ACIDUM - BARIUM OXALSUCCINICUM - BRYONIA ALBA - CALCAREA CARBONICA - CARTILAGO SUIS - CHLORINUM - CIMICIFUGA RACEMOSA - COLCHICUM AUTUMNALE - DULCAMARA - EMBRYO SUIS - FUNICULUS UMBILICALIS SUIS - GLANDULA SUPRARENALIS SUIS - NADIDUM - NATRUM OXALACETICUM - NATRUM SULPHURICUM - PLACENTA TOTALIS SUIS - RHUS TOXICODENDRON - SULPHUR- VENA SUIS -Guna spaaebb990a-65bc-54ed-e053-2995a90a56822020-10-23WarningsExact identifier
unii: PQ6CK8PD0R

Reported adverse events (FAERS/openFDA)#

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