FDA.reportPublic FDA data

NDC 61269-164 - Vitamins A, C, D and 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
61269-164
Package NDCs from labels
61269-164-50
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
Vitamins A, C, D and Fluoride Drops - H2-Pharma, LLCH2-Pharma, LLC2025-09-15DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-164-50Vitamins A, C, D and Fluoride Drops1 in 1 CARTONSOLUTION/ DROPS14
61269-164-50Vitamins A, C, D and Fluoride Drops50 mL in 1 BOTTLESOLUTION/ DROPS504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-164VITAMINS A, C, D AND FLUORIDE DROPS (VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, AND SODIUM FLUORIDE) SOLUTION/ DROPS [H2-PHARMA, LLC]32 package rows20220202_a029ef7b-3f7e-43dc-a200-e1ca47cd6d1c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-164-50ML - Milliliter61269-16485f76f98-e5a7-4535-af78-f19da21959ef12017-04-05

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 9 of 88 · 1,755 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Plus Scope plus Whitening Minty Fresh with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ed8e02-3c2f-750c-e063-6394a90a4d332026-06-23WarningsExact identifier
unii: 8ZYQ1474W7
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Anticavity Fluoride RinseSODIUM FLUORIDEH E Bc68b0644-685d-4c62-bf5d-3a5bbea3b0522026-06-22Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
BoosterviteMULTIVITAMINPureTek Corporation53efbf65-8844-8486-e063-6394a90a51d32026-06-18Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
unii: 1C6V77QF41
VitramynFOLIC ACIDPureTek Corporationc8af7616-5178-6df0-e053-2a95a90a334d2026-06-18Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
unii: 1C6V77QF41
PreviDent 5000 Plus FruitasticSODIUM FLUORIDEColgate Oral Pharmaceuticals Inc.5ef93306-59dd-447b-a2ec-dd865e52c76b2026-06-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent 5000 Booster Plus SpearmintSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.4ef2b7ed-41c3-41cb-8ee0-1930ab8fb1982026-06-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent Alcohol FreeSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.28e4f7cd-9fd8-4c7a-9e4b-d747fefc76c02026-06-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
unii: PDC6A3C0OX
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
unii: PDC6A3C0OX
Natural Fluoride Fresh Mint cavity protection whitening fresh breathSODIUM FLUORIDETom's of Maine, Inc.fce5e8b5-34f8-4a45-a662-82c9034198092026-06-16WarningsExact identifier
unii: 8ZYQ1474W7
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
WALGREEN GLYCERIN ADULTGLYCERIN SUPPOSITORYWalgreens20c44346-0b29-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
unii: PDC6A3C0OX
WALGREENS GLYCERINGLYCERIN SUSPENSIONWalgreens20c44346-0b2b-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
unii: PDC6A3C0OX
PreviDent 5000 Enamel ProtectSODIUM FLUORIDE AND POTASSIUM NITRATEColgate Oral Pharmaceuticals, Inc.bbc66b1b-e05c-4e14-bef3-b8bae419fc892026-06-12Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Prenate MiniASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS ASPARTO GLYCINATE, IRON, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND LOWBUSH BLUEBERRYAvion Pharmaceuticals, LLC8ab766c2-d554-4141-92b2-fbe038e80c9f2026-06-12Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
unii: 1C6V77QF41

Reported adverse events (FAERS/openFDA)#

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