colirio ojo de aguila eye drops

Generic: glycerin, naphazoline hydrochloride

Labeler: grandall distributing co., inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name colirio ojo de aguila eye drops
Generic Name glycerin, naphazoline hydrochloride
Labeler grandall distributing co., inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

glycerin .25 g/100mL, naphazoline hydrochloride .012 g/100mL

Manufacturer
Grandall Distributing Co., Inc.

Identifiers & Regulatory

Product NDC 48201-106
Product ID 48201-106_4741a1f5-e262-8d85-e063-6394a90a014c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

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 48201106
Hyphenated Format 48201-106

Supplemental Identifiers

RxCUI
1046700
UPC
0348201016131 0348201016155
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 colirio ojo de aguila eye drops (source: ndc)
Generic Name glycerin, naphazoline hydrochloride (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .25 g/100mL
  • .012 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 BOX (48201-106-01) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

48201-106-01 1 BOTTLE, DROPPER in 1 BOX (48201-106-01) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (2)

glycerin (.25 g/100mL) naphazoline hydrochloride (.012 g/100mL)

Linked Drug Pages (1)

Colirio Ojo De Aguila Eye Drops, Colirio Oftal-Mycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4741a1f5-e262-8d85-e063-6394a90a014c", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "upc": ["0348201016131", "0348201016155"], "unii": ["PDC6A3C0OX", "MZ1131787D"], "rxcui": ["1046700"], "spl_set_id": ["31aa07e9-0cc9-2a77-e063-6394a90a4b9d"], "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": ["Grandall Distributing Co., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 BOX (48201-106-01)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "48201-106-01", "marketing_start_date": "20240101"}], "brand_name": "Colirio Ojo De Aguila Eye Drops", "product_id": "48201-106_4741a1f5-e262-8d85-e063-6394a90a014c", "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": "48201-106", "generic_name": "Glycerin, Naphazoline hydrochloride", "labeler_name": "Grandall Distributing Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Colirio Ojo De Aguila Eye Drops", "active_ingredients": [{"name": "GLYCERIN", "strength": ".25 g/100mL"}, {"name": "NAPHAZOLINE HYDROCHLORIDE", "strength": ".012 g/100mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}