FDA.reportPublic FDA data

OASIS Tears

Product NDC
42126-6100
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

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 Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX
Rxcui2702674, 2702676

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

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
42126-6100-2421266100025 VIAL, SINGLE-USE in 1 POUCH (42126-6100-2) / .3 mL in 1 VIAL, SINGLE-USE2017-11-010000-00-00NoNoCurrent