Opcon-A

Manufacturer: REMEDYREPACK INC.
Effective date: 2019-03-28
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 00:28:37

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

Contacts and useful links#

PhoneLabel contact1-800-553-5340

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

Purpose

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

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)
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

Call: 1-800-553-5340

3976101

AB55211

®/™ are trademarks of Bausch & Lomb

Incorporated or its affiliates.

©Bausch & Lomb Incorporated

Distributed by: Bausch + Lomb, a Division

of Valeant Pharmaceuticals North

America LLC, Bridgewater, NJ 08807

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Opcon-A

GENERIC: Naphazoline hydrochloride and Pheniramine maleate

DOSAGE: SOLUTION/ DROPS

ADMINSTRATION: OPHTHALMIC

NDC: 70518-0475-0

PACKAGING: 15 mL in 1 BOTTLE, DROPPER

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

NAPHAZOLINE HYDROCHLORIDE 0.2675mg in 1mL
PHENIRAMINE MALEATE 3.15mg in 1mL

INACTIVE INGREDIENT(S):

BENZALKONIUM CHLORIDE
SODIUM BORATE
SODIUM CHLORIDE
WATER
BORIC ACID
EDETATE DISODIUM
HYDROCHLORIC ACID
HYPROMELLOSES

Remedy_Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-430-15	ML - Milliliter	24208-430	f8a4f895-d79c-44b4-85db-5e7720d6589f	1	2022-06-06

Products#

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

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

Opcon-A
Naphazoline hydrochloride and Pheniramine maleate
BENZALKONIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM
HYPROMELLOSES
WATER
SODIUM BORATE
SODIUM CHLORIDE
HYDROCHLORIC ACID
NAPHAZOLINE HYDROCHLORIDE
NAPHAZOLINE
PHENIRAMINE MALEATE
PHENIRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70518-0475	70518-0475-0
24208-430

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
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
WATER	059QF0KO0R	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
NAPHAZOLINE HYDROCHLORIDE	MZ1131787D	ACTIB
PHENIRAMINE MALEATE	NYW905655B	ACTIB

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020065-001	OPCON-A	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1994-06-08

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Opcon-A	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	Bausch & Lomb Incorporated	90a05c13-5b87-415b-9892-10d2edbc1943	2023-12-14	Warnings	Exact identifier ndc (product): 24208-430
852b1b49-6ba6-0d01-e053-2a91aa0a0986			78686984-e9df-45fe-b86e-806c334970a9	2019-03-28	Warnings	Exact identifier spl id: 852b1b49-6ba6-0d01-e053-2a91aa0a0986 spl set id: 78686984-e9df-45fe-b86e-806c334970a9

Reported adverse events (FAERS/openFDA)#

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