FDA.reportPublic FDA data

NDC 61269-161 - MultiVitamin with 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
61269-161
Package NDCs from labels
61269-161-50
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
MultiVitamin with Fluoride Drops - H2-Pharma, LLCH2-Pharma, LLC2025-09-15DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-161-50MultiVitamin with Fluoride Drops50 mL in 1 BOTTLESOLUTION/ DROPS504
61269-161-50MultiVitamin with Fluoride Drops1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-161MULTIVITAMIN WITH FLUORIDE DROPS (VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, AND SODIUM FLUORIDE) SOLUTION/ DROPS [H2-PHARMA, LLC]32 package rows20220915_cbcc97c9-c526-4710-95ed-c72d54ab6250.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-161-50ML - Milliliter61269-16126e86acd-4613-428c-b98d-a2087086298812017-04-05

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 6 of 98 · 1,957 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
unii: 6OZP39ZG8H
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
unii: P6YC3EG204
unii: 68Y4CF58BV
unii: 1C6V77QF41
unii: H4N855PNZ1
thiamine hydrochlorideTHIAMINE HYDROCHLORIDESagent Pharmaceuticals5982cf83-01d6-4acb-8373-339079b8a76e2026-07-22Warnings, Adverse reactionsExact identifier
unii: M572600E5P
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
Freshen Up twisted peppermintSODIUM FLUORIDEDabur India Limited56aac7a7-c086-2fa5-e063-6294a90aa9592026-07-15WarningsExact identifier
unii: 8ZYQ1474W7
Freshen Up Vanilla MintSODIUM FLUORIDEDabur India Limited56aad223-db88-7cf6-e063-6394a90a6b722026-07-15WarningsExact identifier
unii: 8ZYQ1474W7
Freshen UpSODIUM FLUORIDEMKJ BRANDS LLC2dcd4816-caa5-c006-e063-6394a90ac4872026-07-15WarningsExact identifier
unii: 8ZYQ1474W7
Freshen UpSODIUM FLUORIDEDABUR INDIA LIMITED56acecd2-6966-2ee4-e063-6394a90a356f2026-07-15WarningsExact identifier
unii: 8ZYQ1474W7
Colgate Max Fresh Advanced WhiteningSODIUM FLUORIDEColgate-Palmolive Company01c07c25-2748-4d90-9505-094e2c977c9c2026-07-15WarningsExact identifier
unii: 8ZYQ1474W7
Crest StrawberrySODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d51c67b-7409-e5a7-e053-2a91aa0a81fa2026-07-14WarningsExact identifier
unii: 8ZYQ1474W7
Freshen Up Vanilla MintSODIUM FLUORIDEMKJ BRANDS LLC525662da-42be-eaa6-e063-6294a90af1102026-07-14WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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