NDC 68983-006-01 - iBrite

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
68983-006
Requested NDC
68983-006-01
Package NDCs from labels
68983-006-01, 68983-006-02, 68983-006-03, 68983-006-04
Manufacturer
Pac-Dent International Inc.
Effective date
2015-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
iBrite - Pac-Dent International Inc.Pac-Dent International Inc.2015-12-02HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68983-006-022020-01-31C16284748780-19d75b9d1-03f9-f424-e053-dadaa90a57ce25f0e453-ed76-141b-e054-00144ff8d46c
68983-006-042020-01-31C16284748780-19d75b9d1-03f9-f424-e053-dadaa90a57ce25f0e453-ed76-141b-e054-00144ff8d46c

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 83 of 85 · 1,696 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TreprostinilTREPROSTINILDr.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
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
AvantSODIUM FLUORIDEDharma Research, Inc.184bbe52-3909-45f6-b4d0-fe7849fabc1c2021-01-25Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
GRAFCO APPLICATOR 15 CMSILVER NITRATEGF Health Products, Inc.41a82a8c-9a4a-4610-a115-8d8c72a25b1e2021-01-19WarningsExact identifier
unii: RU45X2JN0Z
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium Fluoride 5000 ppm Enamel ProtectSODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%Sheffield Pharmaceuticals LLC83dfdead-4f71-404e-90ae-dbd6849c7cf12021-01-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
unii: RU45X2JN0Z
Ionite APF NeutralSODIUM FLUORIDEDharma Research, inc.ad7a660b-274c-417e-bdf3-1d5addf06ad12020-11-18WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.8ff1b377-0535-4548-a109-f9f1a43b85b72020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.e6c31330-43e0-4d32-af54-ff852af39cab2020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.bc9664df-c4eb-4d29-b1c0-4d4dff6a75e42020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.b8b7f9b8-ff11-4a76-ab36-7822c15e18922020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.e1797adf-4665-4322-a3aa-dd2da9dcd3a82020-11-16WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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