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 209 of 245 · 4,888 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntisepticALCOHOL, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.71aeaf86-2b4d-4945-9606-a9db0ab6b7262024-02-07WarningsExact identifier
unii: 3K9958V90M
Hydrogen PeroxideHYDROGEN PEROXIDESafetec of America, Inc.a665e2ce-c7e1-4d79-aa58-da7595944e7f2024-02-07WarningsExact identifier
unii: BBX060AN9V
ArmiCare Hand SanitizerALCOHOLArmis Biopharma, Incacd02e65-7dfb-4d72-af5d-8063cce982f62024-02-06WarningsExact identifier
unii: 3K9958V90M
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfe04c244-d9b8-2800-e053-6294a90aeedc2024-02-06WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta ClassicCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a4cf29-39ed-87c3-e063-6394a90a49732024-02-05WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Vanilla CaramelCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a66d74-74b4-3f8d-e063-6394a90a7f002024-02-05WarningsExact identifier
unii: 92RU3N3Y1O
AntisepticALCOHOLSafetec of America, Inc.aeecceb7-0753-4908-b1a2-d7e18ba350ec2024-02-05WarningsExact identifier
unii: 3K9958V90M
AntimicrobialALCOHOLSafetec of America, Inc.4a070d45-f7fd-4eab-a2ba-48445d54fe5d2024-02-05WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLTEKWELD SOLUTIONS, INC.45af86a4-a413-0309-e054-00144ff88e882024-02-05WarningsExact identifier
unii: 3K9958V90M
Right Remedies Maximum Strength Gas Relief SoftgelSIMETHICONEStrive Pharmaceuticals Inc.032b3a89-1bc4-4f38-ba9e-0a48402153302024-02-05WarningsExact identifier
unii: 92RU3N3Y1O
Instant Hand SanitizerALCOHOLSafetec of America, Inc.6d8677fa-8d7e-4eb5-9f20-ec5a84e1c23f2024-02-04WarningsExact identifier
unii: 3K9958V90M
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDEProficient Rx LP61daa681-05a0-4b2f-a6d0-c6fc1044f5212024-02-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Ear RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1043debe-8787-a2f5-e063-6294a90a2a662024-01-31WarningsExact identifier
unii: 660YQ98I10
Ear RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1045ab27-c4d5-fcbd-e063-6294a90a51762024-01-31WarningsExact identifier
unii: 660YQ98I10
TinnitusACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.10462aaa-96d4-4ba3-e063-6294a90a79152024-01-31WarningsExact identifier
unii: 660YQ98I10
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.fe08221d-74d5-490a-8db4-eaf3ed20b2892024-01-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc2024-01-29WarningsExact identifier
unii: 92RU3N3Y1O
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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