topcare health ultra itch relief astringent eye drops

Generic: tetrahydrozoline hcl, zinc sulfate

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

Drug Facts

Product Profile

Brand Name topcare health ultra itch relief astringent eye drops
Generic Name tetrahydrozoline hcl, zinc sulfate
Labeler topco associates llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

tetrahydrozoline hydrochloride .05 g/100mL, zinc sulfate .25 g/100mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-855
Product ID 36800-855_0cfa87ca-f1d4-c578-e063-6394a90a7626
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2020-02-01

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800855
Hyphenated Format 36800-855

Supplemental Identifiers

RxCUI
1043249
UPC
0036800036406
UNII
0YZT43HS7D 89DS0H96TB

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 health ultra itch relief astringent eye drops (source: ndc)
Generic Name tetrahydrozoline hcl, zinc sulfate (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .05 g/100mL
  • .25 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (36800-855-01) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

Ingredients (2)

tetrahydrozoline hydrochloride (.05 g/100mL) zinc sulfate (.25 g/100mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "0cfa87ca-f1d4-c578-e063-6394a90a7626", "openfda": {"upc": ["0036800036406"], "unii": ["0YZT43HS7D", "89DS0H96TB"], "rxcui": ["1043249"], "spl_set_id": ["9c617e34-fc64-1a5b-e053-2995a90ace2c"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (36800-855-01)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "36800-855-01", "marketing_start_date": "20200201"}], "brand_name": "Topcare Health Ultra Itch Relief Astringent Eye Drops", "product_id": "36800-855_0cfa87ca-f1d4-c578-e063-6394a90a7626", "dosage_form": "SOLUTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "36800-855", "generic_name": "tetrahydrozoline HCl, zinc sulfate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Health Ultra Itch Relief Astringent Eye Drops", "active_ingredients": [{"name": "TETRAHYDROZOLINE HYDROCHLORIDE", "strength": ".05 g/100mL"}, {"name": "ZINC SULFATE", "strength": ".25 g/100mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200201", "listing_expiration_date": "20261231"}