colirio oftal-mycin

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 oftal-mycin
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 48201-107
Product ID 48201-107_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 48201107
Hyphenated Format 48201-107

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 oftal-mycin (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 (48201-107-01) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

48201-107-01 1 BOTTLE, DROPPER in 1 BOX (48201-107-01) / 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 (48201-107-01)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "48201-107-01", "marketing_start_date": "20240101"}], "brand_name": "Colirio Oftal-Mycin", "product_id": "48201-107_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": "48201-107", "generic_name": "Glycerin, Naphazoline hydrochloride", "labeler_name": "Grandall Distributing Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Colirio Oftal-Mycin", "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"}