FDA.reportPublic FDA data

NAPHCON A

Product NDC
52959-107
11-digit product format
529590107
Labeler code
52959
Product ID
52959-107_740dff9d-17a9-ffc8-e053-2991aa0ad3a5
Type
HUMAN OTC DRUG
Nonproprietary name
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
H.J. Harkins Company, Inc.
Application
NDA020226
Marketing category
NDA
Marketing start
2016-01-26
Marketing end
0000-00-00
Substance
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength
0 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-107-032020-01-31C16284748780-19d75b9d0-0b26-f424-e053-dadaa90a57ce0107-03

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-107-03NAPHCON A15 mL in 1 BOTTLESOLUTION/ DROPS151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-107-03ML - Milliliter52959-1077c5b666e-92b3-418b-86ad-db708c36b75a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-107NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20180823_73fa33b5-606a-d6a8-e053-2991aa0a81c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043658naphazoline HCl 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionPSN73fa33b5-606a-d6a8-e053-2991aa0a81c11
1046266NAPHCON A 0.025 % / 0.3 % Ophthalmic SolutionPSN73fa33b5-606a-d6a8-e053-2991aa0a81c11
1046266naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic Solution [Naphcon A]SBD73fa33b5-606a-d6a8-e053-2991aa0a81c11
1043658naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic SolutionSCD73fa33b5-606a-d6a8-e053-2991aa0a81c11
1043658naphazoline hydrochloride 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionSY73fa33b5-606a-d6a8-e053-2991aa0a81c11
1046266Naphcon A (naphazoline HCl 0.025 % / pheniramine maleate 0.3 % ) Ophthalmic SolutionSY73fa33b5-606a-d6a8-e053-2991aa0a81c11
1046266Naphcon A 0.025 % / 0.3 % Ophthalmic SolutionSY73fa33b5-606a-d6a8-e053-2991aa0a81c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-107-035295901070315 mL in 1 BOTTLE15 mlHistorical