FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Colirio Oftal-Mycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN.25 g/100mL
NAPHAZOLINE HYDROCHLORIDE.012 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMZ1131787D, PDC6A3C0OX
Rxcui1046700

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48201-107-01Colirio Oftal-Mycin15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
48201-107-01Colirio Oftal-Mycin1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48201-107COLIRIO OJO DE AGUILA EYE DROPS (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS COLIRIO OFTAL-MYCIN (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [GRANDALL DISTRIBUTING CO., INC.]1Current NDC, 2 package rows20250403_31aa07e9-0cc9-2a77-e063-6394a90a4b9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionPSN31aa07e9-0cc9-2a77-e063-6394a90a4b9d2
1046700glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML Ophthalmic SolutionSCD31aa07e9-0cc9-2a77-e063-6394a90a4b9d2
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionSY31aa07e9-0cc9-2a77-e063-6394a90a4b9d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
48201-107-01482010107011 BOTTLE, DROPPER in 1 BOX (48201-107-01) / 15 mL in 1 BOTTLE, DROPPER2024-01-01NoNoCurrent