FDA.reportPublic FDA data

Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XL

Product NDC
87354-002
11-digit product format
873540002
Labeler code
87354
Product ID
87354-002_498954b3-bc1e-0b1b-e063-6294a90ab074
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin Ophthalmic Solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
M & M PRODUCTS, L.L.C.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-01
Substance
GLYCERIN
Active strength
5 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 PROFESSIONAL STRENGTH XL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN5 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
2540675Internal RxNorm lookup
2609932Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48d6dc98-66e8-b499-e063-6394a90ae935Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87354-002-01Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XL1 mL in 1 BOTTLESOLUTION/ DROPS12
87354-002-01Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XL1 in 1 CARTONSOLUTION/ DROPS12

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 10 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Winco Original Formula Eye DropsTETRAHYDROZOLINE HCLWinCo Foods, LLC44266952-4054-4c12-b3fc-d0543fe54fe22025-12-30WarningsExact identifier
application number: M018
Winco Irritation Relief EyeTETRAHYDROZOLINE HCL, ZINC SULFATEWinCo Foods, LLC60565184-5745-43a5-92b2-ab45b27e8bc62025-12-30WarningsExact identifier
application number: M018
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
application number: M018
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
application number: M018
Best Choice Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEBest Choice (Valu Merchandisers Company)f5e665e4-ebd7-8c35-e053-2995a90a88112025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
application number: M018
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
application number: M018
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLCf710d107-0403-21c5-e053-6394a90a03722025-12-30WarningsExact identifier
application number: M018
CVS Astringent EyeTETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.07e1a56b-fdad-408d-bf5a-7a0144ece1312025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
application number: M018
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMCVS Pharmacy, Inc.8eef499d-c60e-9468-e053-2995a90a87142025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Lubricating Tears Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC0042337b-c22a-157a-e063-6394a90a202e2025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye Drops OriginalPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVSbb1ad35a-79ea-639f-e053-2995a90a96f32025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLStrategic Sourcing Services LLC0019cd99-b245-2ffc-e063-6294a90a9f272025-12-30WarningsExact identifier
application number: M018
CVS Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.be3d7855-cc66-ace8-e053-2a95a90ab8f42025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Dry Eye ReliefPOLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC0018ade9-5856-db6c-e063-6394a90a2ccf2025-12-30WarningsExact identifier
application number: M018
CareOne Itchy Relief Eye Drops 15mLTETRAHYDROZOLINE HCI, ZINC SULFATERetail Business Services, LLC.997f16ff-2632-2e9d-e053-2995a90a6f512025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLStrategic Sourcing Services LLC0042e9a0-9693-d7e0-e063-6294a90ae6c62025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2540675glycerin 0.5 % Ophthalmic SolutionPSN48d6dc98-66e8-b499-e063-6394a90ae9352
2609932Regener-Eyes 0.5 % Ophthalmic SolutionPSN48d6dc98-66e8-b499-e063-6394a90ae9352
2609932glycerin 5 MG/ML Ophthalmic Solution [Regener-Eyes]SBD48d6dc98-66e8-b499-e063-6394a90ae9352
2540675glycerin 5 MG/ML Ophthalmic SolutionSCD48d6dc98-66e8-b499-e063-6394a90ae9352
2540675glycerin 0.5 % Ophthalmic SolutionSY48d6dc98-66e8-b499-e063-6394a90ae9352
2609932Regener-Eyes 0.5 % Ophthalmic SolutionSY48d6dc98-66e8-b499-e063-6394a90ae9352
2609932Regener-Eyes 5 MG/ML Ophthalmic SolutionSY48d6dc98-66e8-b499-e063-6394a90ae9352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87354-002-01873540002011 BOTTLE in 1 CARTON (87354-002-01) / 1 mL in 1 BOTTLE1 bottle2026-02-01NoNoCurrent