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 26 of 96 · 1,919 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Vitamin C SerumVITAMIN CFlexiGo Inc496e7d41-2176-7b0c-e063-6394a90a98f12026-01-28WarningsExact identifier
unii: 25X51I8RD4
unii: PQ6CK8PD0R
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey PunchSODIUM FLUORIDEAshtel Studios Inc.023cb63c-52b4-4723-bff6-c25105a53f762026-01-28WarningsExact identifier
unii: 8ZYQ1474W7
Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike StrawberrySODIUM FLUORIDEAshtel Studios, Inc.ef4ea4a3-c1ac-447f-a70b-e3a330928cfd2026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum)SODIUM FLUORIDEMade by Dentists Inc.f3f6b32d-8e47-4f52-bd9a-20bd51c9d0072026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
Gethorey MIRACLE BALMHYALURONIC ACID 1% VITAMIN E 0.5% MIRACLE BALMJiangxi Yudexi Pharmaceutical Co., LTD496a7c75-cac5-f152-e063-6394a90a5ce42026-01-27WarningsExact identifier
unii: H4N855PNZ1
Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand GrapeSODIUM FLUORIDEAshtel Studios Inc.6c6d143f-4c2b-4207-bde7-9df8251616a32026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELONSODIUM FLUORIDEAshtel Studios, Inc.d80d0a87-5d1f-4114-977a-036ffed772052026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
Dialyvite 5000ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA97791f73-e0c5-45a6-8aed-f456a5466eaf2026-01-27Adverse reactionsExact identifier
unii: 25X51I8RD4
unii: PQ6CK8PD0R
unii: 68Y4CF58BV
Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard BerrySODIUM FLUORIDEAshtel Studios, Inc.ac18dd0a-d476-48a7-8493-594a0293b9262026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
DialyviteASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACIDHillestad Pharmaceuticals USA7a5e6dd6-5687-44bb-8964-841961c0e64a2026-01-27Adverse reactionsExact identifier
unii: 25X51I8RD4
unii: PQ6CK8PD0R
unii: 68Y4CF58BV
Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRYSODIUM FLUORIDEAshtel Studios, Inc.2500e14e-6cf4-4ac4-810f-1ef163c5e4742026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
Dialyvite Supreme DASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA46fc3acf-1e6d-4830-ae9a-abd9c1132fca2026-01-27Adverse reactionsExact identifier
unii: 25X51I8RD4
unii: PQ6CK8PD0R
unii: 68Y4CF58BV
unii: 1C6V77QF41
Hello Unicorn SplashSODIUM FLUORIDEAccupac LLC23807810-990a-b723-e063-6394a90aee3e2026-01-22WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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