FDA.reportPublic FDA data

OASIS Tears

Product NDC
42126-6100
Requested package NDC
42126-6100-1
11-digit product format
421266100
Labeler code
42126
Product ID
42126-6100_b01eee93-b0f8-4523-8b85-3076dd02a272
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
OASIS Medical, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-11-01
Substance
GLYCERIN
Active strength
.22 g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42126-610042126-6100-1UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42126-610042126-6100-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
OASIS Tears
Brand name suffix
Preservative-Free Lubricant Eye
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN.22 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2702674Internal RxNorm lookup
2702676Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9d71b1d-82a6-42e7-9ef2-2d041daef936Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42126-6100-1OASIS TearsPreservative-Free Lubricant Eye10 in 1 POUCHSOLUTION/ DROPS104
42126-6100-1OASIS TearsPreservative-Free Lubricant Eye3 in 1 CARTONSOLUTION/ DROPS34
42126-6100-2OASIS TearsPreservative-Free Lubricant Eye5 in 1 POUCHSOLUTION/ DROPS54
42126-6100-2OASIS TearsPreservative-Free Lubricant Eye0.3 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.34

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GlycerinACTIVE INGREDIENTPDC6A3C0OXOASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
GlycerinACTIVE MOIETYPDC6A3C0OXOASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
Hyaluronate SodiumINACTIVE INGREDIENTYSE9PPT4THOASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XOASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
Sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74OASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
Sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWOASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0ROASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42126-6100OASIS TEARS PRESERVATIVE-FREE LUBRICANT EYE (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]4Current NDC, Legacy NDC, 4 package rows20250122_d9d71b1d-82a6-42e7-9ef2-2d041daef936.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 1 of 26 · 512 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
application number: M018
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
application number: M018
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
application number: M018
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
application number: M018
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
application number: M018
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
application number: M018
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
application number: M018
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
application number: M018
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
application number: M018
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
application number: M018
OHTrust Artifical EyedropSODIUM CHLORIDENanoplus Technology Co., Limited2ea26d96-704b-17bb-e063-6394a90a7e272026-07-01WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
application number: M018
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
application number: M018
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
application number: M018
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
application number: M018
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUM 0.5%CARDINAL HEALTH 110, LLC. DBA LEADER51a2d74f-5ff3-9921-e063-6294a90a345a2026-06-15WarningsExact identifier
application number: M018
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratories51cadca6-a31b-c1b5-e063-6394a90a34d32026-06-15WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2702674glycerin 0.22 % Ophthalmic SolutionPSNd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702676Oasis TEARS PF 0.22 % Ophthalmic SolutionPSNd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702676glycerin 2.2 MG/ML Ophthalmic Solution [Oasis Tears]SBDd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702674glycerin 2.2 MG/ML Ophthalmic SolutionSCDd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702674glycerin 0.22 % Ophthalmic SolutionSYd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702676Oasis Tears 2.2 MG/ML Ophthalmic SolutionSYd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702676Oasis Tears PF 0.22 % Ophthalmic SolutionSYd9d71b1d-82a6-42e7-9ef2-2d041daef9364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42126-6100-1421266100013 POUCH in 1 CARTON (42126-6100-1) / 10 VIAL, SINGLE-USE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-USE3 pouch2017-11-010000-00-00NoNoCurrent