Regener-Eyes

Product NDC: 82305-003
Requested package NDC: 82305-003-01
11-digit product format: 823050003
Labeler code: 82305
Product ID: 82305-003_ef2e8bc5-977f-20b3-e053-2995a90ac23c
Type: HUMAN OTC DRUG
Nonproprietary name: Regener-Eyes
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: 15 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	82305-003	82305-003-01	I	Inactivated by FDA		2026-10-05

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82305-003-01	Regener-EyesPRO	3 in 1 BOX	SOLUTION/ DROPS	3	8
82305-003-01	Regener-EyesPRO	3 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	3	8
82305-003-02	Regener-EyesPRO	1 in 1 BOX	SOLUTION/ DROPS	1	8
82305-003-02	Regener-EyesPRO	3 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	3	8

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82305-003	REGENER-EYES PRO (REGENER-EYES) SOLUTION/ DROPS [REGENERATIVE PROCESSING PLANT, LLC]	8	Legacy NDC, 4 package rows	20250322_e689001a-3640-1d45-e053-2995a90a4032.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2540675	glycerin 0.5 % Ophthalmic Solution	PSN	e689001a-3640-1d45-e053-2995a90a4032	8
2609932	Regener-Eyes 0.5 % Ophthalmic Solution	PSN	e689001a-3640-1d45-e053-2995a90a4032	8
2609932	glycerin 5 MG/ML Ophthalmic Solution [Regener-Eyes]	SBD	e689001a-3640-1d45-e053-2995a90a4032	8
2540675	glycerin 5 MG/ML Ophthalmic Solution	SCD	e689001a-3640-1d45-e053-2995a90a4032	8
2540675	glycerin 0.5 % Ophthalmic Solution	SY	e689001a-3640-1d45-e053-2995a90a4032	8
2609932	Regener-Eyes 0.5 % Ophthalmic Solution	SY	e689001a-3640-1d45-e053-2995a90a4032	8
2609932	Regener-Eyes 5 MG/ML Ophthalmic Solution	SY	e689001a-3640-1d45-e053-2995a90a4032	8

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
82305-003-01	82305000301	3 BOTTLE, DROPPER in 1 BOX (82305-003-01) > 3 mL in 1 BOTTLE, DROPPER	2022-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WATER - Regenerative Processing Plant, LLC \| Regenerative Processing Plant	Regenerative Processing Plant, LLC \| Regenerative Processing Plant	2025-03-20	HUMAN OTC DRUG LABEL	8