NDC 44038-0322 - HISMILE

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
44038-0322
Package NDCs from labels
44038-0322-1
Manufacturer
Accupac LLC
Effective date
2024-09-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HISMILE - Accupac LLCAccupac LLC2024-09-18HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44038-0322HISMILE (SODIUM FLUORIDE) GEL [ACCUPAC LLC]2Unmatched20240921_22794069-382d-b71d-e063-6394a90aef6d.zip

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 76 of 79 · 1,564 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PureLife APFSODIUM FLUORIDEPureLife Dental44b91f76-1b7a-40fc-9c80-e1c915b3d2ca2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Zap NeutralSODIUM FLUORIDECrosstex International Inc.e1dc8865-a193-44e7-b628-3c4e5d5953182022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.6c1907d6-5b22-40fc-b94e-42af7b5239022022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.fdf5c2e5-9939-448f-99ec-4de513e32fc12022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.c2d3d7f9-00cf-4d85-af51-71f150cd02892022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.080e7f9d-273e-4f3b-bc84-f7c0dd3cf94c2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.01d48cbb-fbd6-477f-81ce-1e388718a4312022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.b1d799c6-e483-44fd-b07c-94ca2ee239ef2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.c33e0e2e-7c68-4908-8bd4-6a3669c8774b2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLCb83c62be-8e9d-4fa2-aa10-d34c88bf23872021-10-01WarningsExact identifier
unii: 8ZYQ1474W7
KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLC427f25e6-e50a-407a-a6f0-512123e381e42021-10-01WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NATRIUM PHOSPHORICUM 6XSODIUM PHOSPHATESeroyal USA22cc1c1e-626f-4a15-e054-00144ff88e882021-07-14WarningsExact identifier
unii: SE337SVY37
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Wentworth Alcohol FreeSODIUM FLUORIDESheffield Pharmaceuticals LLC5ed816ef-20bc-49ac-9202-8fac1edac5792021-03-23Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride 5000 ppm Dry MouthSODIUM FLUORIDESheffield Pharmaceuticals LLCcbc67f03-55c4-4781-ba37-87c737b602822021-03-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, Inc.ab9b07ad-f6b2-4289-bec4-fec58270dc972021-02-20WarningsExact identifier
unii: 8ZYQ1474W7
AvantSODIUM FLUORIDEDharma Research, Inc.4749dce1-c0b9-4737-8a30-85cd58aba21b2021-01-25Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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