FDA.reportPublic FDA data

NDC 69697-991 - Q2 Oral Care Kit with CHG

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
69697-991
Package NDCs from labels
69697-991-01
Manufacturer
Halyard Health | Avent | Elba | Hi Tech Pharmacal
Effective date
2016-01-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Q2 Oral Care Kit with CHG - Halyard Health | Avent | Elba | Hi Tech PharmacalHalyard Health | Avent | Elba | Hi Tech Pharmacal2016-01-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69697-991-01Q2 Oral Care Kit with CHG14 mL in 1 CUP, UNIT-DOSEMOUTHWASH56 mL0.015 mg in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69697-991Q2 ORAL CARE KIT WITH CHG (HYDROGEN PEROXIDE AND CHLORHEXIDINE GLUCONATE) KIT [HALYARD HEALTH]1Unmatched20160128_b2f446b9-9f9f-4380-b5dc-55e3a1c06fff.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 236 of 243 · 4,841 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kali MuriaticumKALI MURIATICUMHahnemann Laboratories, INC.e3c8e13d-a67d-162c-e053-2a95a90abd112022-07-14Exact identifier
unii: 660YQ98I10
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
KALIUM MURIATICUM 6XPOTASSIUM CHLORIDESeroyal USA22c95b6a-dd5d-476e-e054-00144ff8d46c2022-07-07WarningsExact identifier
unii: 660YQ98I10
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ethylicum (ETOH, aka Alcoholus)ETHYLICUM (ETOH, AKA ALCOHOLUS)Hahnemann Laboratories, INC.e1fef03a-ed76-4294-e053-2995a90aee672022-06-21Exact identifier
unii: 3K9958V90M
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEFresenius Kabi, USA, LLCeb360dc4-88d6-4b28-9b61-bc359e16bd222022-05-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
Acidum BenzoicumACIDUM BENZOICUMHahnemann Laboratories, INC.dca1f84c-443f-61ba-e053-2995a90a618a2022-04-14Exact identifier
unii: 8SKN0B0MIM
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
unii: ZY81Z83H0X
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
unii: ZY81Z83H0X
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe Mexico, S.A. de C.V.3e2e5f52-db54-4635-83a8-a67a683c093c2022-03-22WarningsExact identifier
unii: 660YQ98I10
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe North America, Inc.94de9ce3-6ee9-4322-bda2-0b4391f09d872022-03-22WarningsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEB. Braun Medical Inc.ab67b151-8368-4321-b562-bad5eff7b7402022-02-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDETris Pharma Inc159ddd0b-847e-4ecc-b3b2-9634cbb4dfa92022-01-26Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEVistaPharm, LLC7fb18b56-a76d-4f15-9438-c941def76fdb2022-01-19Warnings, Adverse reactionsExact identifier
rxcui: 834127
unii: MOR84MUD8E
Schusslers ImmuneECHINACEA, FERRUM PHOSPHORICUM, KALI MURIATICUM, ZINCUM GLUCONICUMNartex Laboratorios Homeopaticos, S.A. de C.V.d46a3ac3-a37a-743d-e053-2a95a90ab0b12022-01-13WarningsExact identifier
unii: 660YQ98I10
EAR RXACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUMMiami Beach Pediatrics paa8753f88-4b8a-472f-a4bd-f2e9cec836102021-12-29WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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