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 40 of 63 · 1,248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Hello Unicorn SparkleSODIUM FLUORIDEColgate-Palmolive Company5acfbd9b-278c-24dd-8041-5e2cdffbf7102025-05-13WarningsExact identifier
unii: 8ZYQ1474W7
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh MintSODIUM FLUORIDEKenvue Brands LLC346daeae-7590-176c-e063-6294a90a52ea2025-05-05WarningsExact identifier
unii: 8ZYQ1474W7
PhexxLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.14b01a15-9b47-4be3-bb2e-a2010eab429e2025-05-02Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Evo Sensitive Whitening Anti-cavity Fluoride MouthwashSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.3de0d71a-7704-97dd-e063-6294a90a5d2c2025-05-01WarningsExact identifier
unii: 8ZYQ1474W7
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus ScopeSODIUM FLUORIDENavajo Manufacturing Company Inc3adb1524-0fd6-4728-b757-dcbda4cdd0fb2025-04-29WarningsExact identifier
unii: 8ZYQ1474W7
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDOCSMEDI Co., Ltd.3382776a-a10e-1823-e063-6394a90a6f912025-04-24WarningsExact identifier
unii: 8ZYQ1474W7
Listerine Clinical Solutions Enamel Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC11e1c1d0-465b-9e14-e063-6394a90a8cdd2025-04-22WarningsExact identifier
unii: 8ZYQ1474W7
Hello Kids Wild Strawberry Wild StrawberrySODIUM FLUORIDEColgate-Palmolive Company39dddf11-45a0-b883-e12f-d80c582e8c892025-04-15WarningsExact identifier
unii: 8ZYQ1474W7
Hello Magical MermaidSODIUM FLUORIDEColgate-Palmolive Companybdabf74f-8d1e-0f11-159a-0025bcd0ca3e2025-04-15WarningsExact identifier
unii: 8ZYQ1474W7
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.300303e7-ef8b-7449-e063-6294a90ac8112025-04-09WarningsExact identifier
unii: 8ZYQ1474W7
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.303d4ad0-5a2b-347a-e063-6394a90aa0ba2025-04-07WarningsExact identifier
unii: 8ZYQ1474W7
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 2968PHW8QP
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEAilex Pharmaceuticals, LLC329655ae-c3c0-46b2-a925-e49777f2076b2025-03-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
OralLine KidsSODIUM FLUORIDEJ.M. Murray Center Inc.12c5bee5-e228-4f71-9bfd-c377ee2372a92025-03-21WarningsExact identifier
unii: 8ZYQ1474W7
AdoptaPlatoonSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDc1592b56-cf3d-4a4d-be84-e40eb3f1456e2025-03-21WarningsExact identifier
unii: 8ZYQ1474W7
OralLine SecureSODIUM FLUORIDEJ.M. Murray Center Inc.4c0970e9-7417-4234-89e3-3b602a609af52025-03-20WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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