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 59 of 63 · 1,248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
60 Second Fluoride GelSODIUM FLUORIDEDarby Dental Supply, LLC90a2e268-bee8-498d-e053-2995a90ad52b2022-01-24WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.898c0b7f-7ebb-4dba-9ebf-9d1e4805a8c62022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.ec50b003-cf61-4f66-bb62-f779e48363c22022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.f05390e2-9a0a-46fc-9da4-ad2651487b0a2022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.57d70fbe-a0cc-4aaa-b2c7-b9843455d1d92022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.1c5e2cf3-99ef-4737-941e-bc7fb90259e42022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.9cc82e34-9b2d-4815-b9ff-99d2292faff22022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.26f3c9a5-7181-4d82-8fa2-21cebd0906202022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.2bf99955-b32e-498e-87dd-a91c8af259482022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.a857af18-8eb8-47dc-bb26-73a321ed643c2022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.0dedcb47-7851-4fde-8a46-7d1155839a572022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc2ba4a209-c56f-4cbe-8727-d428d2090b082022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc129ecbf8-17c8-4259-a4ca-7c0a09298bb02022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc852de04d-f608-4f7f-b76b-25a29967c0902022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inccec13e9e-2b99-48a1-9833-c49b18c726142022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc7da82945-3186-40b2-b67e-642bdfa9578a2022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inca481e755-6a82-4634-9aa6-bfc7325ccd2c2022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Incbe046466-234e-4742-9bdb-12a13caa6b472022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc6631aeb7-d892-41dc-97e3-655a8059734f2022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.0da6a9de-ad38-4c75-8e88-b68dfc638edc2022-01-20WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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