Home NDC 48201-107 Colirio Oftal-Mycin
Product NDC 48201-107
11-digit product format 482010107
Labeler code 48201
Product ID 48201-107_4741a1f5-e262-8d85-e063-6394a90a014c
Type HUMAN OTC DRUG
Nonproprietary name Glycerin, Naphazoline hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Grandall Distributing Co., Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength .25; .012 g/100mL; g/100mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Colirio Oftal-Mycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN .25 g/100mL NAPHAZOLINE HYDROCHLORIDE .012 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII lookup MZ1131787D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046700 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 48201-107-01 Colirio Oftal-Mycin 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 2 48201-107-01 Colirio Oftal-Mycin 1 in 1 BOX SOLUTION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 48201-107 COLIRIO OJO DE AGUILA EYE DROPS (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS COLIRIO OFTAL-MYCIN (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [GRANDALL DISTRIBUTING CO., INC.] 1 Current NDC, 2 package rows 20250403_31aa07e9-0cc9-2a77-e063-6394a90a4b9d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 6 of 25 · 494 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 48201-107-01 48201010701 1 BOTTLE, DROPPER in 1 BOX (48201-107-01) / 15 mL in 1 BOTTLE, DROPPER 2024-01-01 No No Current