Opcon-A

Manufacturer
Bausch & Lomb Incorporated
Effective date
2026-03-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:51:04

Label at a glance#

ProductOpcon-A
Active ingredientNAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander

Dosage and administration

Adults and children 6 years of age and older: Instill 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#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

Purposes

OTC - PURPOSE SECTION

Redness reliever

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander

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 solution changes color or becomes cloudy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • overuse may cause more eye redness
  • pupils may become enlarged temporarily
  • do not touch tip of container to any surface to avoid contamination
  • you may feel a brief tingling after putting drops in eye
  • replace cap after use
  • remove contact lenses before using

Stop use and ask a doctor if you experience

OTC - STOP USE SECTION

  • eye pain
  • changes in vision
  • redness or irritation of the eye that worsens or lasts more than 72 hours

Keep out of 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 oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older:

    Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

  • Children under 6 years:ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at 20-25 °C (68-77 °F)
  • this package is child-resistant
  • protect from light
  • use before expiration date marked on the carton or bottle

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, hypromellose, purified water, sodium borate, sodium chloride. Hydrochloric acid may be used to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

[phone icon] call: 1-800-553-5340

Distributed by:
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton
carton

NDC 24208-431-15

BAUSCH + LOMB

Opcon-A ®
pheniramine maleate 0.315% and naphazoline
hydrochloride 0.02675% ophthalmic solution
ANTIHISTAMINE AND REDNESS RELIEVER

EYE DROPS
CLINICALLY PROVEN
EYE ALLERGY RELIEF

itching + redness

caused by pollen, ragweed,

grass, animal hair and dander

[teardrop icon]

STERILE 0.5 FL OZ (15 mL)

3844702
AB55211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043704naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic SolutionPSN2
1043708Opcon-A 0.02675 % / 0.315 % Ophthalmic SolutionPSN2
1043708naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic Solution [Opcon-A]SBD2
1043704naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic SolutionSCD2
1043704naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic SolutionSY2
1043704naphazoline HCl 0.027 % / pheniramine maleate 0.315 % Ophthalmic SolutionSY2
1043708Opcon A (naphazoline hydrochloride 0.027 % / pheniramine maleate 0.315 % ) Ophthalmic SolutionSY2
1043708Opcon-A (naphazoline hydrochloride 0.02675 % / pheniramine maleate 0.315 % ) Ophthalmic SolutionSY2

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
24208-431-15Opcon-A1 in 1 CARTONSOLUTION/ DROPS12
24208-431-15Opcon-A15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
24208-431-45Opcon-A2 in 1 CARTONSOLUTION/ DROPS22
24208-431-45Opcon-A15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

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
24208-43124208-431-15, 24208-431-45

Ingredients#

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

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

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
N020065-001OPCON-ANAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE0.02675%;0.315%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 22:38:342026-08N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0884e616aacf4f…
2026-08-18 06:07:402026-07N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-083f01610625f2…
2019-09-15 20:21 UTC2019-09N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020065-001OPCON-A0.02675%;0.315%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
Opcon-ANAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEBausch & Lomb Incorporated2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52026-03-20WarningsExact identifier
ndc (package): 24208-431-15
ndc (package): 24208-431-45
ndc (product): 24208-431
ndc11 (package): 24208043115
ndc11 (package): 24208043145
spl id: 4d7aecbc-8808-0b52-e063-6394a90a72a8
spl set id: 2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5

Reported adverse events (FAERS/openFDA)#

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