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 18 of 100 · 1,996 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adrenal SupportADRENALINUM, BERBERIS VULGARIS, ARGENTUM NITRICUM, NATRUM MURIATICUM, VANADIUM METALLICUM, OLEUM MORRHUAE, PETROLEUMNaturalCarecee52757-a86e-4251-b65f-954ac85f4e7e2026-01-30WarningsExact identifier
unii: 451W47IQ8X
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
application number: M018
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.7b15d6fa-eb04-41d2-8a01-6e7408ccf4d32026-01-30WarningsExact identifier
unii: 451W47IQ8X
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
application number: M018
CVS ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTCVS44821c47-63f9-5d0a-e063-6394a90a555d2026-01-29WarningsExact identifier
unii: 451W47IQ8X
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
application number: M018
Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/DropsHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolabf27a6799-e2f1-ee8d-e053-2a95a90aead12026-01-27WarningsExact identifier
application number: M018
Carboxymethylcellulose Sodium Eye Drops 0.5%CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%Aurolabe8b4df3b-3d81-b3ca-e053-2a95a90af2ec2026-01-27WarningsExact identifier
application number: M018
rxcui: 1188426
unii: K679OBS311
Aurovisc OEHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolab3142c6df-77ac-ec41-e063-6294a90aee472026-01-27WarningsExact identifier
application number: M018
AURO-CMCCARBOXYMETHYLCELLULOSE EYE DROPS 0.5%Aurolabe90b397f-fe64-8674-e053-2995a90a223f2026-01-27WarningsExact identifier
application number: M018
rxcui: 1188426
unii: K679OBS311
Optase AllegroHYDROXYETHYL CELLULOSEScope Health Incf7999928-f5c1-98d6-e053-6294a90a57db2026-01-27WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDENephron Pharmaceuticals Corporationa4edf2d5-a9ff-30d4-e053-2995a90a56502026-01-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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