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 90 of 100 · 1,996 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Talbots Infant Pain Inflamtion ReliefARNICA 12X,BELLIS PERENNIS 12X,CALENDULA OFFICINALIS 12X,CHAMOMILLA 12X,COFFEA CRUDA 12X,HYPERICUM 12X,MILLEFOLIUM 12X,FERRUM PHOSPHORICUM 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 6XTalbots Pharmaceuticals Family Products, LLC.e892c0cb-03b4-52da-e053-2995a90a08782022-09-12WarningsExact identifier
unii: 660YQ98I10
Dr Talbots Infant Daily Allergy ReliefALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bdcc8a-c947-ff5d-e053-2a95a90a3b922022-09-12WarningsExact identifier
unii: 451W47IQ8X
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
application number: M018
unii: K679OBS311
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLC6a1322c7-7767-4569-aa22-9d2e363312832022-08-30WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDr. Reddys Laboratories, Inc.dda82a38-0c08-4947-99b7-915c2949bf162022-08-29Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: 91MBZ8H3QO
Kids Cold and Cough Nighttime Grape FlavorONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e676dbb7-212f-47e3-e053-2995a90af4e12022-08-17WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Daytime Grape FlavorONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFURHyland's Consumer Health Inc.e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d2022-08-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist PediaMedsSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5b580-1d9f-3081-e053-2995a90a80312022-08-08WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse BreatheSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5c313-046f-b0a7-e053-2a95a90a2a072022-08-08WarningsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEActavis Pharma, Inc.db002ae3-f54c-40a4-9cb4-e5681bf426e32022-08-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEActavis Pharma, Inc.ed5baaf6-270b-4dd3-b100-36030c0098fc2022-08-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation123bd10a-90c7-499e-97f6-acf7e0f0fb4e2022-07-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Magnesia MuriaticaMAGNESIA MURIATICAHahnemann Laboratories, INC.e45cf05f-7ca8-2654-e053-2a95a90a74252022-07-21Exact identifier
unii: 02F3473H9O
Kali MuriaticumKALI MURIATICUMHahnemann Laboratories, INC.e3c8e13d-a67d-162c-e053-2a95a90abd112022-07-14Exact identifier
unii: 660YQ98I10
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCfad9615f-7004-415d-9f69-ee9ff95f00672022-07-12WarningsExact identifier
unii: 451W47IQ8X
BHI ConstipationDIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEEDMediNatura Inc0365b75b-fee4-4c1d-89ab-c692bdd73f752022-07-07WarningsExact identifier
unii: 451W47IQ8X
KALIUM MURIATICUM 6XPOTASSIUM CHLORIDESeroyal USA22c95b6a-dd5d-476e-e054-00144ff8d46c2022-07-07WarningsExact identifier
unii: 660YQ98I10
Natrium Muriaticum 6XSODIUM CHLORIDESeroyal USA0ebf18de-12fe-0bc4-e054-00144ff88e882022-07-07WarningsExact identifier
unii: 451W47IQ8X
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
application number: M018
ndc (package): 0023-0798-02
ndc (package): 0023-0798-04
ndc (package): 0023-0796-15
ndc (package): 0023-0798-01
ndc (package): 0023-0795-65
ndc (package): 0023-0797-05
ndc (package): 0023-0798-03
ndc (package): 0023-0798-15
ndc (product): 0023-0798
ndc (product): 0023-0795
rxcui: 1188426
spl id: 104a1738-87e4-4eae-b584-93ceb264f77a
spl set id: 329d1fe0-4432-4565-b7b1-65666bd86526
unii: K679OBS311

Reported adverse events (FAERS/openFDA)#

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