FDA.reportPublic FDA data

Regener-Eyes

Product NDC
82305-006
11-digit product format
823050006
Labeler code
82305
Product ID
82305-006_ef2e6158-d8e8-6736-e053-2a95a90a02dd
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Regenerative Processing Plant, LLC
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-08-24
Marketing end
0000-00-00
Substance
GLYCERIN
Active strength
12 mg/3mL
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82305-006IInactivated by FDA2026-10-05
excluded packagepackage82305-00682305-006-01IInactivated by FDA2026-10-05
excluded packagepackage82305-00682305-006-02IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82305-006-01Regener-EyesLITE3 in 1 BOXSOLUTION/ DROPS39
82305-006-01Regener-EyesLITE3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS39
82305-006-02Regener-EyesLITE3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS39
82305-006-02Regener-EyesLITE1 in 1 BOXSOLUTION/ DROPS19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82305-006REGENER-EYES LITE (GLYCERIN) SOLUTION/ DROPS [REGENERATIVE PROCESSING PLANT, LLC]9Legacy NDC, 4 package rows20250322_e7796d0d-13d7-73c3-e053-2995a90a8bde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2610311glycerin 0.4 % Ophthalmic SolutionPSNe7796d0d-13d7-73c3-e053-2995a90a8bde9
2610313Regener-Eyes Lite 0.4 % Ophthalmic SolutionPSNe7796d0d-13d7-73c3-e053-2995a90a8bde9
2610313glycerin 4 MG/ML Ophthalmic Solution [Regener-Eyes]SBDe7796d0d-13d7-73c3-e053-2995a90a8bde9
2610311glycerin 4 MG/ML Ophthalmic SolutionSCDe7796d0d-13d7-73c3-e053-2995a90a8bde9
2610311glycerin 0.4 % Ophthalmic SolutionSYe7796d0d-13d7-73c3-e053-2995a90a8bde9
2610313Regener-Eyes 4 MG/ML Ophthalmic SolutionSYe7796d0d-13d7-73c3-e053-2995a90a8bde9
2610313Regener-Eyes Lite 0.4 % Ophthalmic SolutionSYe7796d0d-13d7-73c3-e053-2995a90a8bde9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82305-006-01823050006013 BOTTLE, DROPPER in 1 BOX (82305-006-01) > 3 mL in 1 BOTTLE, DROPPER2022-08-240000-00-00NoNoCurrent
82305-006-02823050006023 mL in 1 BOTTLE, DROPPER3 mlHistorical