FDA.reportPublic FDA data

NDC 44946-1032 - Sodium Fluoride

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
44946-1032
Package NDCs from labels
44946-1032-8
Manufacturer
Sancilio & Company Inc
Effective date
2018-03-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sodium Fluoride - Sancilio & Company IncSancilio & Company Inc2018-03-06DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44946-1032-8Sodium Fluoride50 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44946-1032SODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]51 package rows20180324_01013faa-33e3-48a4-b710-d996fac43b61.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44946-1032-8ML - Milliliter44946-10323caf5222-8075-4f8b-929e-be5157faad6312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7SODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Fluoride IonACTIVE MOIETYQ80VPU408OSODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXSODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TSODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3SODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHSODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4SODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
WaterINACTIVE INGREDIENT059QF0KO0RSODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
XylitolINACTIVE INGREDIENTVCQ006KQ1ESODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2

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 39 of 80 · 1,590 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rain Daily Hydration and Comfort For Dry EyesGLYCERINRain Eye Drops, LLC31d7c204-fb74-fb28-e063-6294a90ab3302025-11-23WarningsExact identifier
unii: PDC6A3C0OX
HEB Extra WhiteningFLUORIDEHEB9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e2025-11-21WarningsExact identifier
unii: 8ZYQ1474W7
HEB Enamel Protection Multi ActionPOTASSIUM NITRATE, SODIUM FLUORIDEHEB8255de83-aa60-b081-e053-2a91aa0afcdc2025-11-21WarningsExact identifier
unii: 8ZYQ1474W7
CVS Enamel GuardFLUORIDECVS Pharmacyd9dfa515-426b-9059-e053-2a95a90a38852025-11-21WarningsExact identifier
unii: 8ZYQ1474W7
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
unii: 8ZYQ1474W7
CVS Extra WhiteningFLUORIDECVS Pharmacy3b019849-6585-4a8c-a90a-c7e9e617b3ef2025-11-21WarningsExact identifier
unii: 8ZYQ1474W7
Walgreens Sensitive Extra WhiteningSODIUM FLUORIDEWalgreense807b8a0-6d58-a15f-e053-2995a90a2ea12025-11-21WarningsExact identifier
unii: 8ZYQ1474W7
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
unii: 8ZYQ1474W7
Pronamel Repair WhiteningFLUORIDERite Aid21645dd5-5cb7-2088-e063-6394a90a61ff2025-11-21WarningsExact identifier
unii: 8ZYQ1474W7
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Brain LiquescenceGINKGO BILOBA, COLCHICUM AUTUMNALE, CONVALLARIA MAJALIS, NUX MOSCHATA, CEREBRUM (SUIS), AGARICUS MUSCARIUS, SCUTELLARIA LATERIFLORA, ANACARDIUM ORIENTALE, RIBOFLAVINUM, AMBRA GRISEA, BARYTA CARBONICA, GLYCERINUMNutritional Specialties, Inc.a5c366f3-fd42-4602-b20b-b7b15fde564e2025-11-19WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
unii: 8ZYQ1474W7
Antifungal creamANTIFUNGAL CREAMGuangzhou Guoyoumi Biotechnology Co Ltd43a5b3c8-3b99-b113-e063-6394a90a9aff2025-11-15WarningsExact identifier
unii: PDC6A3C0OX
Sodium Fluoride 1.1%SODIUM FLUORIDEBurel Pharmaceuticals LLC6e021467-08b3-40b3-9a39-2e9d9830085d2025-11-14Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Signature Care Enamel Guard Sensitive Gentle WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDESafeway83222361-b89d-90e7-e053-2991aa0a75792025-11-14WarningsExact identifier
unii: 8ZYQ1474W7
Target Sensitive Whitening TPSODIUM FLUORIDETargetab9a129e-337b-31fe-e053-2995a90ac6912025-11-14WarningsExact identifier
unii: 8ZYQ1474W7
Signature Care Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDESafeway83225fe5-0490-eb4b-e053-2a91aa0a68792025-11-14WarningsExact identifier
unii: 8ZYQ1474W7
Rite Aid Extra WhiteningFLUORIDERite Aidefe2c6c1-b8c6-4a52-b3c6-c9bfca4505702025-11-14WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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