FDA.reportPublic FDA data

NDC 61269-165 - Sodium 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
61269-165
Package NDCs from labels
61269-165-50
Manufacturer
H2-Pharma, LLC
Effective date
2025-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sodium Fluoride Drops - H2-Pharma, LLCH2-Pharma, LLC2025-09-16DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-165-50Sodium Fluoride Drops50 mL in 1 BOTTLESOLUTION/ DROPS504
61269-165-50Sodium Fluoride Drops1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-165SODIUM FLUORIDE DROPS (SODIUM FLUORIDE) SOLUTION/ DROPS [H2-PHARMA, LLC]32 package rows20220125_25401aaa-287c-4af0-8628-be30434aee40.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-165-50ML - Milliliter61269-16515ce4f32-e06d-46b4-aaa2-84f6d85933ad12017-04-05

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 57 of 63 · 1,248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Phenylacetate and Sodium BenzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALSab40b62b-9f8d-4394-92d5-09d9f1941eaa2023-01-16Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
DARBY APF STRAWBERRYSODIUM FLUORIDEDarby Dental Supply, LLC222b29dc-7ad0-4872-9922-970efad8b7a72023-01-12WarningsExact identifier
unii: 8ZYQ1474W7
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
ZOOBY Growlin GrrrapeSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLCfcebb175-d412-4452-9c7c-a38571006bfc2023-01-03WarningsExact identifier
unii: 8ZYQ1474W7
ZOOBY Gator GumSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLCc257d280-8cf3-43e4-b7b7-0a46f493d5b62023-01-03WarningsExact identifier
unii: 8ZYQ1474W7
ZOOBY Spearmint SafariSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLCbd49f704-4fc4-42a3-aa87-2b41d15d86bb2023-01-03WarningsExact identifier
unii: 8ZYQ1474W7
ZOOBY Happy Hippo CakeSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLCda461cb0-430d-458a-98c0-f713e8d51ddd2023-01-03WarningsExact identifier
unii: 8ZYQ1474W7
ZOOBY Turtle MelonSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLC1dd2d298-ea9a-44d3-85c2-0c000834e7942023-01-03WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum FluoratumNATRUM FLUORATUMHahnemann Laboratories, INC.e54bdb28-890b-4869-e053-2995a90a8efd2022-08-02Exact identifier
unii: 8ZYQ1474W7
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
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

Reported adverse events (FAERS/openFDA)#

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