FDA.reportPublic FDA data

NDC 0023-0797 - REFRESH TEARS

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
0023-0797
Package NDCs from labels
0023-0797-05
Manufacturer
Allergan, Inc.
Effective date
2022-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
REFRESH TEARS ® Drug FactsAllergan, Inc.2022-06-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-0797-05REFRESH TEARS5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS5 mL5 mg in 1mL9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-0797REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) KIT [ALLERGAN, INC.]9Unmatched20240927_329d1fe0-4432-4565-b7b1-65666bd86526.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
carboxymethylcellulose sodiumACTIVE INGREDIENTK679OBS311REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
carboxymethylcelluloseACTIVE MOIETY05JZI7B19XREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
boric acidINACTIVE INGREDIENTR57ZHV85D4REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
chlorine dioxideINACTIVE INGREDIENT8061YMS4RMREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
magnesium chlorideINACTIVE INGREDIENT02F3473H9OREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
potassium chlorideINACTIVE INGREDIENT660YQ98I10REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium borateINACTIVE INGREDIENT91MBZ8H3QOREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium chlorateINACTIVE INGREDIENTT95DR77GMRREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium chloriteINACTIVE INGREDIENTG538EBV4VFREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2

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 67 of 100 · 1,996 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
application number: M018
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA (AMERICAN GINSENG), GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, EPHEDRA VULGARIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.9f8e7917-33df-4059-9ae9-e3d2fbb8e3192024-09-03WarningsExact identifier
unii: 451W47IQ8X
Gum TherapyACONITUM NAPELLUS, ARNICA MONTANA, BISMUTHUM SUBNITRICUM, BORAX, CALCAREA FLUORICA, CALENDULA OFFICINALIS, CISTUS CANADENSIS, HEPAR SULPHURIS CALCAREUM, KALI PHOSPHORICUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NATRUM MURIATICUM, SEPIADeseret Biologicalsceb5203b-b4c8-4c7b-8e18-ccbff5034fc12024-08-29WarningsExact identifier
unii: 91MBZ8H3QO
unii: 451W47IQ8X
Gum TherapyCALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, BORAX, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUSDeseret Biologicals5c741edc-f3ce-4e43-bb3e-fb73166214062024-08-28WarningsExact identifier
unii: 91MBZ8H3QO
unii: 451W47IQ8X
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack863e6980-4a66-48a5-a14f-828a00480c932024-08-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Upper Respiratory SupportALLIUM CEPA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, SALVIA OFFICINALIS, DULCAMARA, EUPHRASIA OFFICINALIS, HYDRASTIS CANADENSIS, NATRUM MURIATICUM, SABADILLA, VISCUM ALBUM, MUCOSA NASALIS SUIS, ACONITUM NAPELLUS, AMMONIUM CARBONICUM, ARSENICUM IODATUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (PRATENSIS), RHUS TOXDeseret Biologicals, Inc.882a284f-aa25-40cf-8aff-fe4c38ff3f0a2024-08-23WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEAmerican Health Packaging8c12c5f8-5950-44e3-9473-a0b95187b43c2024-08-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEEpic Pharma, LLC1373321f-533a-4ab4-8bcd-8bde15371a092024-08-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack7427c29e-55c1-4c30-b091-058c8bec592f2024-08-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf1791d4f-029a-487f-aee1-fc5be246d0bc2024-08-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack80dd5de2-5066-472b-b1f8-88070a5c73882024-08-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
GynestatCIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, AURUM MURIATICUM NATRONATUM, BORAX, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, LILIUM TIGRINUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISEnergique, Inc.3af1d2f1-b3f3-4135-9148-726d08bbd5d42024-08-02WarningsExact identifier
unii: 91MBZ8H3QO
Lymph/Spleen ComboADENOSINUM TRIPHOSPHORICUM DINATRUM, APIS MELLIFICA, CASTANEA VESCA, CEANOTHUS AMERICANUS, CHININUM ARSENICOSUM, FERRUM METALLICUM, HELIANTHUS ANNUUS, JUNIPERUS COMMUNIS, LYMPH NODE (SUIS), MYOSOTIS ARVENSIS, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, QUERCUS GLANDIUM SPIRITUS, SPLEEN (SUIS), SUCCINUM, THYMUS (SUIS), UBIDECARENONUMDeseret Biologicals, Inc.afce86e2-cbfa-44d4-b803-bc2ad50533572024-07-31WarningsExact identifier
unii: 451W47IQ8X
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUMBioActive Nutritional, Inc.7920e8f6-be48-4402-9085-9673779db5a22024-07-31WarningsExact identifier
unii: 660YQ98I10
Lymph/Spleen ComboJUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICADeseret Biologicals, Inc.b55787b5-5e35-4342-8f00-ef202c3538772024-07-31WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: 451W47IQ8X
Pineal LiquescenceVALERIANA OFFICINALIS, HYDROCOTYLE ASIATICA, MELATONIN, CEREBRUM SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), SCUTELLARIA LATERIFLORA, STELLARIA MEDIA, CALCAREA CARBONICA, ZINCUM METALLICUM, AURUM METALLICUM, DOPAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), MAGNESIA MURIATICANutritional Specialties, Inc.ccaf3166-5e2f-4c7f-80a8-ee722bdf0c5b2024-07-24WarningsExact identifier
unii: 02F3473H9O
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEFresenius Kabi USA, LLC3849b89c-c309-46fb-a1e2-53ff0c65077f2024-07-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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