FDA.reportPublic FDA data

Optase

Product NDC
72972-007
11-digit product format
729720007
Labeler code
72972
Product ID
72972-007_49a2fdf9-1bd1-56de-e063-6294a90afdda
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Scope Health Inc
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-07
Substance
GLYCERIN
Active strength
2 mg/mL
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Optase
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN2 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998232Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
10c3e31d-779d-8ff6-e063-6294a90acd39Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72972-007-05Optase1 in 1 BOXSOLUTION/ DROPS14
72972-007-05Optase5 in 1 DOSE PACKSOLUTION/ DROPS54
72972-007-30Optase1 in 1 BOXSOLUTION/ DROPS14
72972-007-30Optase30 in 1 DOSE PACKSOLUTION/ DROPS304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72972-007OPTASE (GLYCERIN) SOLUTION/ DROPS [SCOPE HEALTH INC]2Current NDC, 4 package rows20241220_10c3e31d-779d-8ff6-e063-6294a90acd39.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 7 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vis Guard Lubricant Eye DropsPOLYVINYL ALCOHOL 1.4%Ulai Health LLCe9b0ed39-60c8-1093-e053-2a95a90a705b2026-01-13WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb4697319-438e-2ec8-e053-2a95a90abb562026-01-08WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb478a695-ded0-2e5f-e053-2995a90ac45e2026-01-08WarningsExact identifier
application number: M018
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
application number: M018
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
application number: M018
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
application number: M018
Polyvinyl Alcohol Eye Drops 1,4 % w/vPOLYVINYL ALCOHOL EYE DROPS 1,4 % W/VAurolabe8e09719-6e06-612b-e053-2995a90a79fc2026-01-08WarningsExact identifier
application number: M018
AuroviscHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolabe9100312-b105-50a6-e053-2a95a90ac31f2026-01-08WarningsExact identifier
application number: M018
TheraTears Dry and TiredCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC02b70e2d-8159-4637-a282-9eac1468e7862026-01-07WarningsExact identifier
application number: M018
VISTA Hypromellose Dry Eye ReliefHYPROMELLOSERed Wedding LLCb2c4954c-ed53-778a-e053-2a95a90ae0d02026-01-01WarningsExact identifier
application number: M018
Colirio Ojo De Aguila Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEGrandall Distributing Co., Inc.31aa07e9-0cc9-2a77-e063-6394a90a4b9d2025-12-31WarningsExact identifier
application number: M018
Value Health by Prodose Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Prodose, Inc.3fafa362-a8a6-3f91-e063-6394a90a98b32025-12-31WarningsExact identifier
application number: M018
Signature Care Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands LLC6f1f4f58-3208-4b06-9afb-c4beeed093142025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporation6c449374-8847-4c4a-9073-1951ff31d4042025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporationddc15dac-fbd8-42fa-80db-79f49fc6b9eb2025-12-30WarningsExact identifier
application number: M018
Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMAmerisource Bergen Drug Corp.fd6b2be8-7e00-3765-e053-6294a90a40612025-12-30WarningsExact identifier
application number: M018
Rugby Carboxymethylcellulose Sodium 0.5% Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesfb84fc0b-9a62-812a-e053-6394a90aba0a2025-12-30WarningsExact identifier
application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLRugby Laboratories081673b2-5c74-1200-e063-6394a90ae3632025-12-30WarningsExact identifier
application number: M018
Medi-First Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUnifirst First Aid Corporationa4e651cc-adf0-af9e-e053-2995a90ace5a2025-12-30WarningsExact identifier
application number: M018
Green Guard Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUniFirst First Aid Corporationc3f04fdb-9fc1-797d-e053-2995a90afe802025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998232glycerin 0.2 % Ophthalmic SolutionPSN10c3e31d-779d-8ff6-e063-6294a90acd394
998232glycerin 2 MG/ML Ophthalmic SolutionSCD10c3e31d-779d-8ff6-e063-6294a90acd394
998232glycerin 0.2 % Ophthalmic SolutionSY10c3e31d-779d-8ff6-e063-6294a90acd394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72972-007-05729720007051 DOSE PACK in 1 BOX (72972-007-05) / 5 BOTTLE, UNIT-DOSE in 1 DOSE PACK / .5 mL in 1 BOTTLE, UNIT-DOSE1 dose pack2024-02-07YesNoCurrent
72972-007-30729720007301 DOSE PACK in 1 BOX (72972-007-30) / 30 BOTTLE, UNIT-DOSE in 1 DOSE PACK / .5 mL in 1 BOTTLE, UNIT-DOSE1 dose pack2024-02-07YesNoCurrent