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

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 Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX
Rxcui2610311, 2610313

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

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 bottle2026-02-01NoNoHistorical