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 4 of 64 · 1,273 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
unii: 8ZYQ1474W7
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
unii: 8ZYQ1474W7
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
unii: 8ZYQ1474W7
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
unii: 8ZYQ1474W7
MySweetSmile Strawberry Toothpaste.MYSWEETSMILE STRAWBERRY TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478cf338-2c98-2770-e063-6294a90a13762026-07-24WarningsExact identifier
unii: 8ZYQ1474W7
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
unii: 8ZYQ1474W7
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
unii: 8ZYQ1474W7
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
unii: 8ZYQ1474W7
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
unii: 8ZYQ1474W7
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
unii: 8ZYQ1474W7
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
unii: 8ZYQ1474W7
Colgate Ultra White CharcoalSODIUM FLUORIDEColgate-Palmolive Company95d06fcc-f56d-43f1-924a-3f91fda59bdf2026-07-22WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
COLGATE KPOP DEMON HUNTERS BUBBLE POPSODIUM FLUORIDEColgate-Palmolive Companybf465181-01e9-44ca-91f8-03110a6067742026-07-16WarningsExact identifier
unii: 8ZYQ1474W7
Colgate Minions Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Company16634b99-f305-48bf-ac54-a9f53797a9e52026-07-16WarningsExact identifier
unii: 8ZYQ1474W7
Freshen Up Holiday mintSODIUM FLUORIDEDabur India Limited56aaa9f5-7eac-11d9-e063-6294a90af3a82026-07-15WarningsExact identifier
unii: 8ZYQ1474W7
Freshen Up pepper mintSODIUM FLUORIDEDabur India Limited56aaba60-523e-6ac7-e063-6394a90a27562026-07-15WarningsExact identifier
unii: 8ZYQ1474W7
Freshen-up Matcha MintSODIUM FLUORIDEDabur India Limited56aac050-73e7-298c-e063-6294a90a26eb2026-07-15WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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