FDA.reportPublic FDA data

NAPHCON A

Manufacturer
H.J. Harkins Company, Inc.
Effective date
2018-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:39

Label at a glance#

ProductNAPHCON A
Active ingredientNAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE
Label structure12 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

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

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

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.

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

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

  • ragweed
  • pollen
  • grass
  • animal dander and hair

OTC - PURPOSE SECTION

  • Redness Reliever and Antihistamine Eye Drops
  • Relieves Itching & Redness
  • EYE ALLERGY RELIEF

OTC - ACTIVE INGREDIENT SECTION

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043658naphazoline HCl 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionPSN1
1046266NAPHCON A 0.025 % / 0.3 % Ophthalmic SolutionPSN1
1046266naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic Solution [Naphcon A]SBD1
1043658naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic SolutionSCD1
1043658naphazoline hydrochloride 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionSY1
1046266Naphcon A (naphazoline HCl 0.025 % / pheniramine maleate 0.3 % ) Ophthalmic SolutionSY1
1046266Naphcon A 0.025 % / 0.3 % Ophthalmic SolutionSY1

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 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 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

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52959-10752959-107-03

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
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
PHENIRAMINE MALEATENYW905655BACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
740dff9d-17a9-ffc8-e053-2991aa0ad3a573fa33b5-606a-d6a8-e053-2991aa0a81c12018-08-21WarningsExact identifier
spl id: 740dff9d-17a9-ffc8-e053-2991aa0ad3a5
spl set id: 73fa33b5-606a-d6a8-e053-2991aa0a81c1

Reported adverse events (FAERS/openFDA)#

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