visine red eye hydrating comfort eye drops

Generic: tetrahydrozoline hydrochloride and polyethylene glycol 400

Labeler: morning star otc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name visine red eye hydrating comfort eye drops
Generic Name tetrahydrozoline hydrochloride and polyethylene glycol 400
Labeler morning star otc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

polyethylene glycol 400 10 mg/mL, tetrahydrozoline hydrochloride .5 mg/mL

Manufacturer
Morning Star OTC

Identifiers & Regulatory

Product NDC 53209-6001
Product ID 53209-6001_37b48b1a-ef42-afdc-e063-6294a90a6610
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2020-04-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 532096001
Hyphenated Format 53209-6001

Supplemental Identifiers

RxCUI
996209
UNII
B697894SGQ 0YZT43HS7D

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 visine red eye hydrating comfort eye drops (source: ndc)
Generic Name tetrahydrozoline hydrochloride and polyethylene glycol 400 (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 BLISTER PACK (53209-6001-1) / 8 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

53209-6001-1 1 BOTTLE, DROPPER in 1 BLISTER PACK (53209-6001-1) / 8 mL in 1 BOTTLE, DROPPER

Ingredients (2)

polyethylene glycol 400 (10 mg/mL) tetrahydrozoline hydrochloride (.5 mg/mL)

Linked Drug Pages (1)

Visine Red Eye Hydrating Comfort Eye Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "37b48b1a-ef42-afdc-e063-6294a90a6610", "openfda": {"unii": ["B697894SGQ", "0YZT43HS7D"], "rxcui": ["996209"], "spl_set_id": ["dcd4164c-aa1e-4f07-ab2c-b439275629db"], "manufacturer_name": ["Morning Star OTC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 BLISTER PACK (53209-6001-1)  / 8 mL in 1 BOTTLE, DROPPER", "package_ndc": "53209-6001-1", "marketing_start_date": "20250616"}], "brand_name": "Visine Red Eye Hydrating Comfort Eye Drops", "product_id": "53209-6001_37b48b1a-ef42-afdc-e063-6294a90a6610", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "53209-6001", "generic_name": "TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400", "labeler_name": "Morning Star OTC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Visine Red Eye Hydrating Comfort", "brand_name_suffix": "Eye Drops", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 400", "strength": "10 mg/mL"}, {"name": "TETRAHYDROZOLINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200427", "listing_expiration_date": "20261231"}