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 46 of 100 · 1,996 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: 451W47IQ8X
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
application number: M018
potassium chloridePOTASSIUM CHLORIDESolco Healthcare LLC52d91d76-8c7f-40f1-9f5c-e05962cabedd2025-07-15Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLC616f0de7-8843-44a1-8fa6-274d889286aa2025-07-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
KLOR-CONPOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLC1ff53330-065c-4213-9c0c-ac498621d09d2025-07-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
KLOR-CONPOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLCe61a4522-b91d-400a-952c-6f035e4610dd2025-07-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
KLOR-CON MPOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLCb89910f6-4ff5-4a62-8269-696f7c10e4f62025-07-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HerpaOneGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions6b196d97-6446-4651-97ef-6615cf3e31732025-07-11WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDE IN SODIUM CHLORIDESODIUM CHLORIDE AND POTASSIUM CHLORIDEB. Braun Medical Inc.ecc38772-246a-46c4-b42a-b9b81124f27f2025-07-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEUpsher-SmithLaboratories, LLCad584ce4-a64d-4851-80e9-0eeedc0b9d062025-07-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Leader Sinus Wash Saline Refill PacketsSODIUM BICARBONATE, SODIUM CHLORIDECardinal Health, 110 dba LEADERfb192a6d-318e-4d2b-89b6-42ac023e4fbd2025-07-09WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.0d59a04a-32e6-485b-b638-a1e6c09e96422025-07-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Nat Mur Fluid Balance 9NATRUM MURIATICUMMartin & Pleasance Pty Ltd0b21c366-fff6-4754-a671-35481ec2c4bd2025-07-07WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDEAdvanced Rx LLC40f471b7-27cf-4ad4-aef6-cc9d0623ddd92025-07-02WarningsExact identifier
unii: 451W47IQ8X
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0956bd7c-d46f-483a-bf2c-9e11c6111ebf2025-07-02Exact identifier
unii: 02F3473H9O
unii: 451W47IQ8X
unii: M4I0D6VV5M
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb79ef556-37b3-4fd0-8589-c633033be9df2025-07-02Exact identifier
unii: 02F3473H9O
unii: 451W47IQ8X
unii: M4I0D6VV5M
Schuessler Tissue Salts Kali Mur Glandular Tonic 5KALI MURIATICUMMartin & Pleasance Pty Ltd4b2d8d03-c829-4292-ad94-993376d81b8f2025-07-01WarningsExact identifier
unii: 660YQ98I10
ParasodeARTEMISIA VULGARIS ROOT, CHELIDONIUM MAJUS WHOLE, PUNICA GRANATUM ROOT BARK, SPIGELIA ANTHELMIA WHOLE, KRAMERIA LAPPACEA ROOT, ARSENIC TRIOXIDE, IRON, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARTEMISIA CINA PRE-FLOWERING TOP, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS, GRAPHITE, CALOMEL, SODIUM CHLORIDE, AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEZorex0ed722dc-cd25-4a15-b3f8-052cc7bcd9ec2025-07-01WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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