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 58 of 86 · 1,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OASIS Tears Plus Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.ea931c0f-c61e-4771-84f1-0274b1c3e28e2025-01-22WarningsExact identifier
unii: PDC6A3C0OX
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attituded33e3778-ba1d-4560-bafa-74f7ab88c6b52025-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
unii: PDC6A3C0OX
AMERFRESH FLUORIDE gelSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD86279b4d-82e5-45b5-9ba7-94fe3620b8502025-01-16WarningsExact identifier
unii: 8ZYQ1474W7
AMERFRESH FLUORIDESODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD827e45bb-84c0-48ee-a60b-2cc32b8f33e32025-01-16WarningsExact identifier
unii: 8ZYQ1474W7
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel ToothSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDbb93fb1a-885a-4d2a-a1c2-3b37bc305d572025-01-16WarningsExact identifier
unii: 8ZYQ1474W7
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCc68fd8c7-7ec3-cc3f-e053-2995a90a43952025-01-16WarningsExact identifier
unii: 8ZYQ1474W7
Lubricating TearsCARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTIONReliable 1 Laboritories LLC29023a57-eba3-4241-e063-6294a90a70482025-01-15WarningsExact identifier
unii: K679OBS311
Beautyturess Collagen Moisturizing Firming 14-Piece SetBEAUTYTURESS COLLAGEN MOISTURIZING FIRMING 14-PIECE SETGuangdong Bisutang Biotechnology Co., Ltd.2bc94a8a-effb-8319-e063-6394a90a535d2025-01-15WarningsExact identifier
unii: PDC6A3C0OX
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: 1Q73Q2JULR
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f5f9b-4192-15e6-e053-2995a90a64572025-01-09WarningsExact identifier
unii: 8ZYQ1474W7
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLC2b494372-de59-e462-e063-6294a90a08da2025-01-09WarningsExact identifier
unii: 8ZYQ1474W7
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f28f3-a908-47a9-e053-2995a90a6cbd2025-01-09WarningsExact identifier
unii: 8ZYQ1474W7
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC7a295974-c400-4442-9149-138a805ffb202025-01-09WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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