FDA.reportPublic FDA data

Opcon-A

Product NDC
24208-431
11-digit product format
242080431
Labeler code
24208
Product ID
24208-431_4d7aecbc-8808-0b52-e063-6394a90a72a8
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline hydrochloride and Pheniramine maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA020065
Marketing category
NDA
Marketing start
2026-03-19
Substance
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength
.2675; 3.15 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Opcon-A
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HYDROCHLORIDE.2675 mg/mL
PHENIRAMINE MALEATE3.15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMZ1131787D, NYW905655B
Rxcui1043704, 1043708

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
24208-431-15Opcon-A1 in 1 CARTONSOLUTION/ DROPS12
24208-431-15Opcon-A15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
24208-431-45Opcon-A2 in 1 CARTONSOLUTION/ DROPS22
24208-431-45Opcon-A15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043704naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic SolutionPSN2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52
1043708Opcon-A 0.02675 % / 0.315 % Ophthalmic SolutionPSN2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52
1043708naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic Solution [Opcon-A]SBD2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52
1043704naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic SolutionSCD2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52
1043704naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic SolutionSY2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52
1043704naphazoline HCl 0.027 % / pheniramine maleate 0.315 % Ophthalmic SolutionSY2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52
1043708Opcon A (naphazoline hydrochloride 0.027 % / pheniramine maleate 0.315 % ) Ophthalmic SolutionSY2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52
1043708Opcon-A (naphazoline hydrochloride 0.02675 % / pheniramine maleate 0.315 % ) Ophthalmic SolutionSY2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24208-431-15242080431151 BOTTLE, DROPPER in 1 CARTON (24208-431-15) / 15 mL in 1 BOTTLE, DROPPER2026-03-19NoNoCurrent
24208-431-45242080431452 BOTTLE, DROPPER in 1 CARTON (24208-431-45) / 15 mL in 1 BOTTLE, DROPPER2026-03-19NoNoCurrent