FDA.reportPublic FDA data

Naphcon A

Product NDC
0065-0085
11-digit product format
000650085
Labeler code
0065
Product ID
0065-0085_96b9fdb6-f4fe-4350-93a5-d7cfacc83af0
Type
HUMAN OTC DRUG
Nonproprietary name
naphazoline hydrochloride and pheniramine maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0085-15Naphcon A1 in 1 CARTONSOLUTION/ DROPS116
0065-0085-15Naphcon A15 mL in 1 BOTTLESOLUTION/ DROPS1516
0065-0085-38Naphcon A1 in 1 CARTONSOLUTION/ DROPS116
0065-0085-38Naphcon A30 mL in 1 BOTTLESOLUTION/ DROPS3016
0065-0085-42Naphcon A2 in 1 CARTONSOLUTION/ DROPS216
0065-0085-42Naphcon A5 mL in 1 BOTTLESOLUTION/ DROPS516
0065-0085-52Naphcon A5 mL in 1 BOTTLESOLUTION/ DROPS516
0065-0085-52Naphcon A1 in 1 CARTONSOLUTION/ DROPS116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0085-15ML - Milliliter0065-0085089b2d21-fcf9-4e1a-a86b-bdd8e313cfdb12013-02-13
0065-0085-42ML - Milliliter0065-0085af92d8ef-1313-424b-a7b4-5dac3652e96f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Naphazoline HydrochlorideACTIVE INGREDIENTMZ1131787DNAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
Pheniramine MaleateACTIVE INGREDIENTNYW905655BNAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
NaphazolineACTIVE MOIETYH231GF11BVNAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
PheniramineACTIVE MOIETY134FM9ZZ6MNAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
Boric AcidINACTIVE INGREDIENTR57ZHV85D4NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KNAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBNAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
Sodium BorateINACTIVE INGREDIENT91MBZ8H3QONAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XNAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
Sodium HydroxideINACTIVE INGREDIENT55X04QC32INAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RNAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0085NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]16Current NDC, Legacy NDC, 8 package rows20240331_4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043658naphazoline HCl 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionPSN4d8412ff-0e59-4a6a-9f3e-4e6f6204bf5816
1046266NAPHCON A 0.025 % / 0.3 % Ophthalmic SolutionPSN4d8412ff-0e59-4a6a-9f3e-4e6f6204bf5816
1046266naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic Solution [Naphcon A]SBD4d8412ff-0e59-4a6a-9f3e-4e6f6204bf5816
1043658naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic SolutionSCD4d8412ff-0e59-4a6a-9f3e-4e6f6204bf5816
1043658naphazoline hydrochloride 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionSY4d8412ff-0e59-4a6a-9f3e-4e6f6204bf5816
1046266Naphcon A (naphazoline HCl 0.025 % / pheniramine maleate 0.3 % ) Ophthalmic SolutionSY4d8412ff-0e59-4a6a-9f3e-4e6f6204bf5816
1046266Naphcon A 0.025 % / 0.3 % Ophthalmic SolutionSY4d8412ff-0e59-4a6a-9f3e-4e6f6204bf5816
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
0065-0085-15000650085151 BOTTLE in 1 CARTON (0065-0085-15) / 15 mL in 1 BOTTLE1 bottle1995-01-030000-00-00NoNoCurrent
0065-0085-38000650085381 in 1 CARTONHistorical
0065-0085-42000650085422 BOTTLE in 1 CARTON (0065-0085-42) > 5 mL in 1 BOTTLE2 bottle1994-06-082023-11-01NoNoCurrent
0065-0085-52000650085521 BOTTLE in 1 CARTON (0065-0085-52) > 5 mL in 1 BOTTLE1 bottle1994-06-080000-00-00NoNoCurrent