topcare maximum redness relief eye drops

Generic: glycerin, naphazoline hydrochloride

Labeler: topco assoc llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare maximum redness relief eye drops
Generic Name glycerin, naphazoline hydrochloride
Labeler topco assoc llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

glycerin .5 g/100mL, naphazoline hydrochloride .03 g/100mL

Manufacturer
Topco Assoc LLC

Identifiers & Regulatory

Product NDC 36800-975
Product ID 36800-975_0cfa9846-2cd8-d0fc-e063-6394a90af06b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2020-02-04

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 36800975
Hyphenated Format 36800-975

Supplemental Identifiers

RxCUI
1235200
UPC
0036800211230
UNII
PDC6A3C0OX MZ1131787D
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 topcare maximum redness relief eye drops (source: ndc)
Generic Name glycerin, naphazoline hydrochloride (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 g/100mL
  • .03 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (36800-975-01) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

36800-975-01 1 BOTTLE, DROPPER in 1 CARTON (36800-975-01) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (2)

glycerin (.5 g/100mL) naphazoline hydrochloride (.03 g/100mL)

Linked Drug Pages (1)

Topcare Maximum Redness Relief Eye Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "0cfa9846-2cd8-d0fc-e063-6394a90af06b", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "upc": ["0036800211230"], "unii": ["PDC6A3C0OX", "MZ1131787D"], "rxcui": ["1235200"], "spl_set_id": ["9c6193a6-d824-1b27-e053-2995a90ab3cf"], "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": ["Topco Assoc LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (36800-975-01)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "36800-975-01", "marketing_start_date": "20200204"}], "brand_name": "Topcare Maximum Redness Relief Eye Drops", "product_id": "36800-975_0cfa9846-2cd8-d0fc-e063-6394a90af06b", "dosage_form": "SOLUTION", "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": "36800-975", "generic_name": "glycerin, naphazoline hydrochloride", "labeler_name": "Topco Assoc LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Maximum Redness Relief Eye Drops", "active_ingredients": [{"name": "GLYCERIN", "strength": ".5 g/100mL"}, {"name": "NAPHAZOLINE HYDROCHLORIDE", "strength": ".03 g/100mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200204", "listing_expiration_date": "20261231"}