FDA.reportPublic FDA data

Regener-Eyes Ophthalmic Solution LITE

Product NDC
87354-003
11-digit product format
873540003
Labeler code
87354
Product ID
87354-003_497763ee-dc71-bb48-e063-6294a90afb3d
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin Ophthalmic Solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
M & M PRODUCTS, LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-01
Substance
GLYCERIN
Active strength
4 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
Regener-Eyes Ophthalmic Solution LITE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN4 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2610311Internal RxNorm lookup
2610313Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
497763ee-dc70-bb48-e063-6294a90afb3dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87354-003-01Regener-Eyes Ophthalmic Solution LITE1 in 1 CARTONSOLUTION/ DROPS11
87354-003-01Regener-Eyes Ophthalmic Solution LITE1 mL in 1 BOTTLESOLUTION/ DROPS11

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 13 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart443e214b-2680-79a9-e063-6294a90a68ba2025-12-20WarningsExact identifier
application number: M018
Equate Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEWalmart44155cf8-6fd9-d16f-e063-6394a90ac7312025-12-20WarningsExact identifier
application number: M018
Original Redness RelieverTETRAHYDROLIZINE HCLWalmart4414f768-0c69-d041-e063-6294a90a5bd92025-12-20WarningsExact identifier
application number: M018
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
application number: M018
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
application number: M018
Signature Care Eye Drops Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEBetter Living Brands LLC901f3bbe-e1bb-4e44-879c-711e59813a7f2025-12-19WarningsExact identifier
application number: M018
STYE RELIEF SERUMCARBOXYMETHYLCELLULOSE SODIUM(CMC)Guangzhou Shimei Cosmetics Co., Ltd.45fa7962-b489-4613-e063-6394a90a59b02025-12-15WarningsExact identifier
application number: M018
Gentle Eyes Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTRP Company13f99af6-b7d8-a092-e063-6394a90a5daa2025-12-15WarningsExact identifier
application number: M018
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
application number: M018
Eyelash SerumEYELASH SERUMFlexiGo Inc4544adf7-bb24-cb10-e063-6294a90aa4142025-12-06WarningsExact identifier
application number: M018
Redness Reliever, Circle KTETRAHYDROZOLINE HYDROCHLORIDE LIQUIDLil' Drug Store products, Inc.44e95d70-f633-1e4e-e063-6294a90a9f212025-12-01WarningsExact identifier
application number: M018
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
application number: M018
Rain Daily Hydration and Comfort For Dry EyesGLYCERINRain Eye Drops, LLC31d7c204-fb74-fb28-e063-6294a90ab3302025-11-23WarningsExact identifier
application number: M018
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalgreen Companya39864a3-2407-7b7e-e053-2a95a90ab92f2025-11-19WarningsExact identifier
application number: M018
Walgreens Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalgreen Companya39919d5-84db-05df-e053-2995a90ab1d22025-11-19WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
application number: M018
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2610311glycerin 0.4 % Ophthalmic SolutionPSN497763ee-dc70-bb48-e063-6294a90afb3d1
2610313Regener-Eyes Lite 0.4 % Ophthalmic SolutionPSN497763ee-dc70-bb48-e063-6294a90afb3d1
2610313glycerin 4 MG/ML Ophthalmic Solution [Regener-Eyes]SBD497763ee-dc70-bb48-e063-6294a90afb3d1
2610311glycerin 4 MG/ML Ophthalmic SolutionSCD497763ee-dc70-bb48-e063-6294a90afb3d1
2610311glycerin 0.4 % Ophthalmic SolutionSY497763ee-dc70-bb48-e063-6294a90afb3d1
2610313Regener-Eyes 4 MG/ML Ophthalmic SolutionSY497763ee-dc70-bb48-e063-6294a90afb3d1
2610313Regener-Eyes Lite 0.4 % Ophthalmic SolutionSY497763ee-dc70-bb48-e063-6294a90afb3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87354-003-01873540003011 BOTTLE in 1 CARTON (87354-003-01) / 1 mL in 1 BOTTLE1 bottle2026-02-01NoNoCurrent