colirio ocusan

Generic: tetrahydrozoline hydrochloride, polyethylene glycol 400, povidone, unspecified, and dextran 70

Labeler: dlc laboratories, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name colirio ocusan
Generic Name tetrahydrozoline hydrochloride, polyethylene glycol 400, povidone, unspecified, and dextran 70
Labeler dlc laboratories, inc.
Dosage Form LIQUID
Routes
OPHTHALMIC
Active Ingredients

dextran 70 1 mg/mL, polyethylene glycol 400 10 mg/mL, povidone, unspecified 10 mg/mL, tetrahydrozoline hydrochloride .5 mg/mL

Manufacturer
DLC Laboratories, Inc.

Identifiers & Regulatory

Product NDC 24286-1575
Product ID 24286-1575_2f3841d0-c77b-aa79-e063-6294a90a53c1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2019-12-16

Pharmacologic Class

Established (EPC)
plasma volume expander [epc]
Mechanism of Action
osmotic activity [moa]
Physiologic Effect
increased intravascular volume [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 242861575
Hyphenated Format 24286-1575

Supplemental Identifiers

RxCUI
996202
UNII
7SA290YK68 B697894SGQ FZ989GH94E 0YZT43HS7D
NUI
N0000184175 N0000009361 N0000010288

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 colirio ocusan (source: ndc)
Generic Name tetrahydrozoline hydrochloride, polyethylene glycol 400, povidone, unspecified, and dextran 70 (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
  • 10 mg/mL
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (24286-1575-1) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

24286-1575-1 1 BOTTLE in 1 BOX (24286-1575-1) / 15 mL in 1 BOTTLE

Ingredients (4)

dextran 70 (1 mg/mL) polyethylene glycol 400 (10 mg/mL) povidone, unspecified (10 mg/mL) tetrahydrozoline hydrochloride (.5 mg/mL)

Linked Drug Pages (1)

Colirio Ocusan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2f3841d0-c77b-aa79-e063-6294a90a53c1", "openfda": {"nui": ["N0000184175", "N0000009361", "N0000010288"], "unii": ["7SA290YK68", "B697894SGQ", "FZ989GH94E", "0YZT43HS7D"], "rxcui": ["996202"], "spl_set_id": ["0f0dd0bd-9a35-4671-933a-f3f8e834ae65"], "pharm_class_pe": ["Increased Intravascular Volume [PE]"], "pharm_class_epc": ["Plasma Volume Expander [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["DLC Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (24286-1575-1)  / 15 mL in 1 BOTTLE", "package_ndc": "24286-1575-1", "marketing_start_date": "20191216"}], "brand_name": "Colirio Ocusan", "product_id": "24286-1575_2f3841d0-c77b-aa79-e063-6294a90a53c1", "dosage_form": "LIQUID", "pharm_class": ["Increased Intravascular Volume [PE]", "Osmotic Activity [MoA]", "Plasma Volume Expander [EPC]"], "product_ndc": "24286-1575", "generic_name": "TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, POVIDONE, UNSPECIFIED, and DEXTRAN 70", "labeler_name": "DLC Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Colirio Ocusan", "active_ingredients": [{"name": "DEXTRAN 70", "strength": "1 mg/mL"}, {"name": "POLYETHYLENE GLYCOL 400", "strength": "10 mg/mL"}, {"name": "POVIDONE, UNSPECIFIED", "strength": "10 mg/mL"}, {"name": "TETRAHYDROZOLINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20191216", "listing_expiration_date": "20261231"}