FDA.reportPublic FDA data

Naphcon A

Manufacturer
A-S Medication Solutions
Effective date
2024-08-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:35

Label at a glance#

ProductNaphcon A
Active ingredientNAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE
Label structure14 sections

Indications and uses

for the temporary relief of redness and itching of the eye(s) due to: ragweed pollen grass animal dander and hair

Dosage and administration

adults and children 6 years and over: put 1 or 2 drops in the affected eye(s) up to 4 times daily children under 6 years: ask a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Naphazoline hydrochloride 0.025%Redness reliever
Pheniramine maleate 0.3%Antihistamine

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of redness and itching of the eye(s) due to:

  • ragweed
  • pollen
  • grass
  • animal dander and hair

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if you are sensitive to any ingredient in this product
  • if this solution changes color or becomes cloudy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • narrow angle glaucoma
  • heart disease
  • high blood pressure
  • trouble urinating

When using this product

OTC - WHEN USING SECTION

  • pupils may become enlarged temporarily causing light sensitivity
  • overuse may cause more eye redness
  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 years and over: put 1 or 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 20°-25°C (68°-77°F)
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid

Questions?

OTC - QUESTIONS SECTION

In the U.S. call 1-800-757-9195 or visit www.alcon.com

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-7165

NDC: 50090-7165-0 15 mL in a BOTTLE / 1 in a CARTON

NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7165NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]1Unmatched20240823_04497f9b-11fc-47ad-9814-7d4800fbebdf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7165-0ML - Milliliter50090-71654fc8e8ad-ec24-47ca-b902-34618a30ad3c12024-09-09
0065-0085-15ML - Milliliter0065-0085089b2d21-fcf9-4e1a-a86b-bdd8e313cfdb12013-02-13
0065-0085-42ML - Milliliter0065-0085af92d8ef-1313-424b-a7b4-5dac3652e96f12013-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-716550090-7165-0
0065-0085

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
PHENIRAMINE MALEATENYW905655BACTIB
Benzalkonium ChlorideF5UM2KM3W7IACT
Boric AcidR57ZHV85D4IACT
Edetate Disodium7FLD91C86KIACT
Water059QF0KO0RIACT
Sodium Borate91MBZ8H3QOIACT
Sodium Chloride451W47IQ8XIACT
Sodium Hydroxide55X04QC32IIACT
Hydrochloric AcidQTT17582CBIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020226-001NAPHCON-ANAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0884e616aacf4f…
2026-08-18 06:07:402026-07N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-083f01610625f2…
2019-09-15 20:21 UTC2019-09N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020226-001NAPHCON-A0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ae55bd4e-450f-4790-aa3d-6f44ffdeb3dc04497f9b-11fc-47ad-9814-7d4800fbebdf2025-09-09WarningsExact identifier
spl set id: 04497f9b-11fc-47ad-9814-7d4800fbebdf
Naphcon ANAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEAlcon Laboratories, Inc.4d8412ff-0e59-4a6a-9f3e-4e6f6204bf582024-03-27WarningsExact identifier
ndc (product): 0065-0085

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.