FDA.reportPublic FDA data

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 45 of 86 · 1,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PCXX NEUTRAL RMS BUBBLEGUMFLUORIDE TREATMENTRoss Healthcare Inc.37f90a0f-2c67-456b-997e-8a8a4f5f09d32025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
PCXX NEUTRAL RNS PEPPERMINTFLUORIDE TREATMENTRoss Healthcare Inc.8532d4d9-c960-0051-e053-2a91aa0ad1a62025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
Atti amour Rose Anti-Aging Repair Classic EssenceNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1e874ac0-a993-be9e-e063-6394a90af4242025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Eye CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eeb9c36-5bd8-ec90-e063-6294a90ae4e12025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair SerumNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eb08f86-eb2a-7f29-e063-6294a90a05162025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Moisturizing CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eec4cfe-d5a3-3570-e063-6294a90ac38b2025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
unii: PDC6A3C0OX
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DentisseSODIUM FLUORIDEDentisse, Inc.326b290a-9bd2-468e-e054-00144ff8d46c2025-11-04WarningsExact identifier
unii: 8ZYQ1474W7
Alpha-ProSODIUM FLUORIDE AND HYDROFLUORIC ACIDDental Technologies, Inc.a86ec65f-f6e1-474d-aeff-412a4716a92c2025-11-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Plak Smacker GREAT WHITE SHARKSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCca5b91aa-f69c-4553-a2b6-acf0ca1d920e2025-11-04WarningsExact identifier
unii: 8ZYQ1474W7
Alpha-ProSODIUM FLUORIDE AND HYDROFLUORIC ACIDDental Technologies, Inc.efe3646d-9eb1-4a49-aeb4-c4c2240568512025-11-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent 5000 Booster Plus FruitasticSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.83986c58-25ed-45a4-9d19-36f6ce32d76c2025-11-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Strawberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426c2aca-ca2b-5e34-e063-6294a90ae37c2025-11-02WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Watermelon Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426e40cb-e30d-0db1-e063-6294a90a762b2025-10-31WarningsExact identifier
unii: 8ZYQ1474W7
Classic Mint Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425a9b71-5a7f-83e6-e063-6394a90ab7032025-10-30WarningsExact identifier
unii: 8ZYQ1474W7
Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425b1a2e-7576-13a7-e063-6394a90aa8652025-10-30WarningsExact identifier
unii: 8ZYQ1474W7
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426b8efa-e691-a67d-e063-6394a90abf8d2025-10-30WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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