regener-eyes ophthalmic solution lite xl

Generic: glycerin ophthalmic solution

Labeler: m & m products, l.l.c.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name regener-eyes ophthalmic solution lite xl
Generic Name glycerin ophthalmic solution
Labeler m & m products, l.l.c.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

glycerin 4 mg/mL

Manufacturer
M & M PRODUCTS, L.L.C.

Identifiers & Regulatory

Product NDC 87354-001
Product ID 87354-001_49894c78-bc00-9116-e063-6294a90ac279
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2027-12-31
Marketing Start 2026-02-01

Pharmacologic Class

Established (EPC)
non-standardized chemical allergen [epc]
Chemical Structure
allergens [cs] glycerol [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 87354001
Hyphenated Format 87354-001

Supplemental Identifiers

RxCUI
2610311 2610313
UNII
PDC6A3C0OX
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name regener-eyes ophthalmic solution lite xl (source: ndc)
Generic Name glycerin ophthalmic solution (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (87354-001-01) / 1 mL in 1 BOTTLE
source: ndc

Packages (1)

Ingredients (1)

glycerin (4 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "49894c78-bc00-9116-e063-6294a90ac279", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["PDC6A3C0OX"], "rxcui": ["2610311", "2610313"], "spl_set_id": ["47ab9609-4291-30b2-e063-6394a90a421e"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["M & M PRODUCTS, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (87354-001-01)  / 1 mL in 1 BOTTLE", "package_ndc": "87354-001-01", "marketing_start_date": "20260201"}], "brand_name": "Regener-Eyes Ophthalmic Solution LITE XL", "product_id": "87354-001_49894c78-bc00-9116-e063-6294a90ac279", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]"], "product_ndc": "87354-001", "generic_name": "Glycerin Ophthalmic Solution", "labeler_name": "M & M PRODUCTS, L.L.C.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Regener-Eyes Ophthalmic Solution LITE XL", "active_ingredients": [{"name": "GLYCERIN", "strength": "4 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260201", "listing_expiration_date": "20271231"}