FDA.reportPublic FDA data

Naphcon A

Product NDC
50090-0185
11-digit product format
500900185
Labeler code
50090
Product ID
50090-0185_34600138-4c39-4860-bfa1-900640f544c7
Type
HUMAN OTC DRUG
Nonproprietary name
naphazoline hydrochloride and pheniramine maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
NDA020226
Marketing category
NDA
Marketing start
1994-06-08
Substance
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength
.25; 3 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
Naphcon A
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HYDROCHLORIDE.25 mg/mL
PHENIRAMINE MALEATE3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMZ1131787D, NYW905655B
Rxcui1043658, 1046266

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
50090-0185-0Naphcon A1 in 1 CARTONSOLUTION/ DROPS115
50090-0185-0Naphcon A15 mL in 1 BOTTLESOLUTION/ DROPS1515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0185-0ML - Milliliter50090-0185010083e8-28d1-45e8-8a1e-6b7bcd6aa11c12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0185NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20231026_df40c426-ef66-4688-b5b5-c6fc5556e9a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043658naphazoline HCl 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionPSNdf40c426-ef66-4688-b5b5-c6fc5556e9a815
1046266NAPHCON A 0.025 % / 0.3 % Ophthalmic SolutionPSNdf40c426-ef66-4688-b5b5-c6fc5556e9a815
1046266naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic Solution [Naphcon A]SBDdf40c426-ef66-4688-b5b5-c6fc5556e9a815
1043658naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic SolutionSCDdf40c426-ef66-4688-b5b5-c6fc5556e9a815
1043658naphazoline hydrochloride 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionSYdf40c426-ef66-4688-b5b5-c6fc5556e9a815
1046266Naphcon A (naphazoline HCl 0.025 % / pheniramine maleate 0.3 % ) Ophthalmic SolutionSYdf40c426-ef66-4688-b5b5-c6fc5556e9a815
1046266Naphcon A 0.025 % / 0.3 % Ophthalmic SolutionSYdf40c426-ef66-4688-b5b5-c6fc5556e9a815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0185-0500900185001 BOTTLE in 1 CARTON (50090-0185-0) / 15 mL in 1 BOTTLE1 bottle2014-11-280000-00-00NoNoCurrent