Opcon-A

Product NDC
24208-430
11-digit product format
242080430
Labeler code
24208
Product ID
24208-430_224a5792-637b-4b92-ba2b-b334e6a06f0f
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
1994-06-08
Substance
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength
.2675; 3.15 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Opcon-A
Listing expiration
2026-12-31

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
24208-430-03Opcon-A3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS37
24208-430-03Opcon-A1 in 1 CARTONSOLUTION/ DROPS17
24208-430-15Opcon-A15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS157
24208-430-15Opcon-A1 in 1 CARTONSOLUTION/ DROPS17
24208-430-30Opcon-A30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS307
24208-430-30Opcon-A1 in 1 CARTONSOLUTION/ DROPS17
24208-430-45Opcon-A15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS157
24208-430-45Opcon-A2 in 1 CARTONSOLUTION/ DROPS27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-430-15ML - Milliliter24208-430f8a4f895-d79c-44b4-85db-5e7720d6589f12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787DOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
PHENIRAMINE MALEATEACTIVE INGREDIENTNYW905655BOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
NAPHAZOLINEACTIVE MOIETYH231GF11BVOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
PHENIRAMINEACTIVE MOIETY134FM9ZZ6MOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4OPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
WATERINACTIVE INGREDIENT059QF0KO0ROPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-430OPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7Current NDC, Legacy NDC, 8 package rows20231215_90a05c13-5b87-415b-9892-10d2edbc1943.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043704naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic SolutionPSN90a05c13-5b87-415b-9892-10d2edbc19437
1043708Opcon-A 0.02675 % / 0.315 % Ophthalmic SolutionPSN90a05c13-5b87-415b-9892-10d2edbc19437
1043708naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic Solution [Opcon-A]SBD90a05c13-5b87-415b-9892-10d2edbc19437
1043704naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic SolutionSCD90a05c13-5b87-415b-9892-10d2edbc19437
1043704naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic SolutionSY90a05c13-5b87-415b-9892-10d2edbc19437
1043704naphazoline HCl 0.027 % / pheniramine maleate 0.315 % Ophthalmic SolutionSY90a05c13-5b87-415b-9892-10d2edbc19437
1043708Opcon A (naphazoline hydrochloride 0.027 % / pheniramine maleate 0.315 % ) Ophthalmic SolutionSY90a05c13-5b87-415b-9892-10d2edbc19437
1043708Opcon-A (naphazoline hydrochloride 0.02675 % / pheniramine maleate 0.315 % ) Ophthalmic SolutionSY90a05c13-5b87-415b-9892-10d2edbc19437

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-430-03242080430031 BOTTLE, DROPPER in 1 CARTON (24208-430-03) > 3 mL in 1 BOTTLE, DROPPER1994-08-060000-00-00NoNoCurrent
24208-430-15242080430151 BOTTLE, DROPPER in 1 CARTON (24208-430-15) / 15 mL in 1 BOTTLE, DROPPER1994-08-060000-00-00NoNoCurrent
24208-430-30242080430301 BOTTLE, DROPPER in 1 CARTON (24208-430-30) > 30 mL in 1 BOTTLE, DROPPER1994-08-060000-00-00NoNoCurrent
24208-430-45242080430452 BOTTLE, DROPPER in 1 CARTON (24208-430-45) / 15 mL in 1 BOTTLE, DROPPER2015-07-010000-00-00NoNoCurrent