Opcon-A

Product NDC: 24208-431
Requested package NDC: 24208-431-15
11-digit product format: 242080431
Labeler code: 24208
Product ID: 24208-431_4d7aecbc-8808-0b52-e063-6394a90a72a8
Type: HUMAN OTC DRUG
Nonproprietary name: Naphazoline hydrochloride and Pheniramine maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: NDA020065
Marketing category: NDA
Marketing start: 2026-03-19
Substance: NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength: .2675; 3.15 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Opcon-A
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPHAZOLINE HYDROCHLORIDE	.2675 mg/mL
PHENIRAMINE MALEATE	3.15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MZ1131787D	Internal UNII lookup
NYW905655B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043704	Internal RxNorm lookup
1043708	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e18001c8-33ae-5f66-9cdc-a39724bd4573	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24208-431-15	Opcon-A	1 in 1 CARTON	SOLUTION/ DROPS	1	2
24208-431-15	Opcon-A	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	2
24208-431-45	Opcon-A	2 in 1 CARTON	SOLUTION/ DROPS	2	2
24208-431-45	Opcon-A	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	2

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 · 8 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	2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	2026-03-20	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065 ndc (package): 24208-431-15 ndc (product): 24208-431 ndc11 (package): 24208043115
EYE ALLERGY RELIEF	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	CVS PHARMACY	253130b4-a23b-43a0-b125-0fa5bd01b2b6	2026-01-15	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Eye Allergy Relief	PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE	Walgreen Company	ddd892af-56d0-4755-af87-807ea8f8e9ca	2026-01-14	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Eye Allergy Relief	PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE	Target Corporation	806ad1b6-0de7-4e9a-be86-475c0ef2c340	2025-03-28	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Eye Allergy Relief	PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE	Rite Aid Corporation	6043040e-3206-40dd-aa87-940b1a84a496	2024-07-22	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Opcon-A	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	Bausch & Lomb Incorporated	90a05c13-5b87-415b-9892-10d2edbc1943	2023-12-14	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Eye Allergy Relief	PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE	Wal-Mart Stores Inc	873a072f-159b-44b8-aad8-33963d961afb	2021-04-05	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Eye Allergy Relief	PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE	DOLGENCORP, LLC	82a99ff3-4f57-42e6-82f4-769d6418be7c	2020-01-27	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MZ1131787D	NAPHAZOLINE HYDROCHLORIDE	550-99-2	NAPHAZOLINE HYDROCHLORIDE
NYW905655B	PHENIRAMINE MALEATE	132-20-7	PHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043704	naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic Solution	PSN	2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	2
1043708	Opcon-A 0.02675 % / 0.315 % Ophthalmic Solution	PSN	2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	2
1043708	naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic Solution [Opcon-A]	SBD	2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	2
1043704	naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic Solution	SCD	2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	2
1043704	naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic Solution	SY	2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	2
1043704	naphazoline HCl 0.027 % / pheniramine maleate 0.315 % Ophthalmic Solution	SY	2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	2
1043708	Opcon A (naphazoline hydrochloride 0.027 % / pheniramine maleate 0.315 % ) Ophthalmic Solution	SY	2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	2
1043708	Opcon-A (naphazoline hydrochloride 0.02675 % / pheniramine maleate 0.315 % ) Ophthalmic Solution	SY	2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
24208-431-15	24208043115	1 BOTTLE, DROPPER in 1 CARTON (24208-431-15) / 15 mL in 1 BOTTLE, DROPPER	2026-03-19	No	No	Current