Regener-Eyes Ophthalmic Solution LITE XL

Product NDC
87354-001
11-digit product format
873540001
Labeler code
87354
Product ID
87354-001_49894c78-bc00-9116-e063-6294a90ac279
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
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 XL
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
87354-001-01Regener-Eyes Ophthalmic Solution LITE XL1 in 1 CARTONSOLUTION/ DROPS12
87354-001-01Regener-Eyes Ophthalmic Solution LITE XL1 mL in 1 BOTTLESOLUTION/ DROPS12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2610311glycerin 0.4 % Ophthalmic SolutionPSN47ab9609-4291-30b2-e063-6394a90a421e2
2610313Regener-Eyes Lite 0.4 % Ophthalmic SolutionPSN47ab9609-4291-30b2-e063-6394a90a421e2
2610313glycerin 4 MG/ML Ophthalmic Solution [Regener-Eyes]SBD47ab9609-4291-30b2-e063-6394a90a421e2
2610311glycerin 4 MG/ML Ophthalmic SolutionSCD47ab9609-4291-30b2-e063-6394a90a421e2
2610311glycerin 0.4 % Ophthalmic SolutionSY47ab9609-4291-30b2-e063-6394a90a421e2
2610313Regener-Eyes 4 MG/ML Ophthalmic SolutionSY47ab9609-4291-30b2-e063-6394a90a421e2
2610313Regener-Eyes Lite 0.4 % Ophthalmic SolutionSY47ab9609-4291-30b2-e063-6394a90a421e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87354-001-01873540001011 BOTTLE in 1 CARTON (87354-001-01) / 1 mL in 1 BOTTLE1 bottle2026-02-01NoNoHistorical