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 59 of 86 · 1,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
unii: PDC6A3C0OX
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
V34 Colour CorrectorV34 COLOUR CORRECTORJiangxi Dentalbright Technology Co., Ltd2b2a0b47-7628-4b85-e063-6294a90a45a02025-01-07WarningsExact identifier
unii: O352864B8Z
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c0ff5df4-0b37-0b1b-e053-2a95a90a862c2025-01-02WarningsExact identifier
unii: O352864B8Z
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c101881a-5a12-2e04-e053-2a95a90a3f572025-01-02WarningsExact identifier
unii: O352864B8Z
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.098a29d5-3836-d362-e063-6394a90a9fea2025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
AVON Whitening Essentials Original Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8e5de76b-535a-9c95-e053-2995a90afcab2025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
AVON Whitening Essentials Blanc Charcoal Fresh MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8f27c88a-7a70-e00a-e053-2a95a90a95a42025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
POP Feeling PeachySODIUM FLUORIDETAI GUK PHARM. CO., LTD0abb7a95-60b1-a1f3-e063-6294a90ace0c2025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
AVON Whitening Essentials Blanc Charcoal Fresh MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.99fff177-6300-220e-e053-2a95a90a06602025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05a9cee1-bd6e-6b93-e063-6294a90a5c102025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
PERIOE POP Advanced Whitening Prebiotic Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f546470a-7fae-4988-e053-2995a90ab61b2025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
PERIOE Microbiome Whitening Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de97dbea-dc8c-ebfa-e053-2995a90a22702025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
POP Gel Pumpin StrawberrySODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b1020b-a1c3-e1eb-e063-6394a90ac2662025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
PERIOE POP Complete Protection Prebiotic Mint BlastSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f547a468-d2fd-7176-e053-2995a90a55392025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
PERIOE Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.b4530d56-3a17-6868-e053-2995a90a25242025-01-01WarningsExact identifier
unii: 8ZYQ1474W7
PERIOE Microbiome Total Care Strong MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de996aeb-9ac0-836f-e053-2a95a90aeda62025-01-01WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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