FDA.reportPublic FDA data

NDC 61269-164 - Vitamins A, C, D and 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
61269-164
Package NDCs from labels
61269-164-50
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
Vitamins A, C, D and Fluoride Drops - H2-Pharma, LLCH2-Pharma, LLC2025-09-15DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-164-50Vitamins A, C, D and Fluoride Drops1 in 1 CARTONSOLUTION/ DROPS14
61269-164-50Vitamins A, C, D and Fluoride Drops50 mL in 1 BOTTLESOLUTION/ DROPS504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-164VITAMINS A, C, D AND FLUORIDE DROPS (VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, AND SODIUM FLUORIDE) SOLUTION/ DROPS [H2-PHARMA, LLC]32 package rows20220202_a029ef7b-3f7e-43dc-a200-e1ca47cd6d1c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-164-50ML - Milliliter61269-16485f76f98-e5a7-4535-af78-f19da21959ef12017-04-05

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 80 of 86 · 1,712 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
unii: 6OZP39ZG8H
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
unii: A2I8C7HI9T
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Iris 60 Second APFSODIUM FLUORIDEBenco Dental5fa57e34-5827-4d37-a5dc-965750e5be502022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dental6a0f889d-5f27-496f-b830-d778ee867ade2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dental8f5d420b-3348-4002-9a09-b05e8cbb35c92022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dentalc93f67f5-9833-4a7a-a67a-49a51843e68d2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dentald5658bf8-3a13-4d8b-b727-5f15759195712022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Burkhart Neutral pHSODIUM FLUORIDEBurkhart Dental Supply Inca7259222-4ee1-42b2-8beb-3f29a5eb29092022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Burkhart Neutral pHSODIUM FLUORIDEBurkhart Dental Supply Inc0fb4d584-36e8-4db7-b72e-04608580dacd2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc2531ad94-b229-4212-a7a3-f793567a06b62022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc804e7850-1952-4e86-804e-d800ee6e7b502022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc87b3b8b8-780f-492d-bd75-b005edd55baa2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc79fa0a42-bb69-49db-9997-1679a75bac262022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Incd7422939-c28e-4bda-b679-81abcc8c36e22022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc192c4e46-0bfd-4f48-901c-ce4f09f91e3e2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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