FDA.reportPublic FDA data

Optase

Product NDC
72972-005
11-digit product format
729720005
Labeler code
72972
Product ID
72972-005_49a65be7-3e7a-0846-e063-6294a90a07fa
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
2023-02-10
Substance
GLYCERIN
Active strength
.25 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
GLYCERIN.25 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f452a2c4-c869-7bf5-e053-2995a90ac1a0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72972-005-01Optase10 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS105
72972-005-01Optase1 in 1 BOXSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72972-005OPTASE (GLYCERIN) SOLUTION/ DROPS [SCOPE HEALTH INC]3Current NDC, 2 package rows20241220_f452a2c4-c869-7bf5-e053-2995a90ac1a0.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 17 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
application number: M018
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
application number: M018
Tyson 2.0 Mike Red Eye Drops For Dry High EyesGLYCERIN, NAPHAZOLINE HCLJbrands Pharma L.L.C.288e9c85-0562-89bf-e063-6394a90a110d2025-02-07WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Incaae783b2-18fe-69ca-e053-2a95a90a08002025-01-30WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Inc82c29f1d-a018-7483-e053-2a91aa0a8f7e2025-01-30WarningsExact identifier
application number: M018
OASIS Tears Lubricant EyeGLYCERINOASIS Medical, Inc.00071697-4ac6-4962-8eee-388b8b52bd402025-01-22WarningsExact identifier
application number: M018
ImproVue LubricantHYPROMELLOSE 2208 (15000 MPA.S)Oculus Surgical, Inc.63b82129-4848-47c5-bf92-ec4b1a9e99742025-01-22WarningsExact identifier
application number: M018
VISCO SHIELD LubricantHYPROMELLOSE 2208 (15000 MPA.S)OASIS Medical, Inc.72d22610-d8ab-4f24-b304-8b013430a7d72025-01-22WarningsExact identifier
application number: M018
OASIS Tears Plus Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.ea931c0f-c61e-4771-84f1-0274b1c3e28e2025-01-22WarningsExact identifier
application number: M018
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
application number: M018
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%Reliable 1 Laboritories LLC29175c17-223e-5e92-e063-6294a90a71d22025-01-15WarningsExact identifier
application number: M018
Lubricating TearsCARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTIONReliable 1 Laboritories LLC29023a57-eba3-4241-e063-6294a90a70482025-01-15WarningsExact identifier
application number: M018
Aurodone Povidone Iodine 5 % Opthalmic SolutionPOVIDONE IODINE 5 % TOPICAL SOLUTIONAurolabf3444446-1dad-79ff-e053-2a95a90af4112025-01-06WarningsExact identifier
application number: M018
Hypromellose Eye Drops 0.7%HYPROMELLOSE EYE DROPS 0.7%Aurolabd35313d0-b190-5fb0-e053-2a95a90a52832025-01-02WarningsExact identifier
application number: M018
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
application number: M018
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
application number: M018
Lubricant Eye PMMINERAL OIL, WHITE PETROLATUMReliable 1 Laboratories LLCbaec8045-97fe-6f60-e053-2a95a90a050e2024-12-31WarningsExact identifier
application number: M018
Lil Drug Store Eye Drops Redness RelieverTETRAHYDROZOLINE HYDROCHLORIDELil Drug Store Products, Incd2a47e98-a04c-47ec-aded-d1c894f040e22024-12-30WarningsExact identifier
application number: M018
Rain Renewal Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRain Eye Drops, LLCaf7a5768-7d1d-3d93-e053-2a95a90a38f62024-12-29WarningsExact identifier
application number: M018
Glitch Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLMisemer Pharmaceutical, Inc03778509-3374-2168-e063-6294a90a95052024-12-23WarningsExact identifier
application number: M018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72972-005-01729720005011 BOTTLE, DISPENSING in 1 BOX (72972-005-01) / 10 mL in 1 BOTTLE, DISPENSING2023-02-10NoNoCurrent