Opcon-A

Product NDC
24208-430
Requested package NDC
24208-430-03
11-digit product format
242080430
Labeler code
24208
Product ID
24208-430_224a5792-637b-4b92-ba2b-b334e6a06f0f
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
1994-06-08
Substance
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength
.2675; 3.15 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage24208-43024208-430-03DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HYDROCHLORIDE.2675 mg/mL
PHENIRAMINE MALEATE3.15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MZ1131787DInternal UNII lookup
NYW905655BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
90a05c13-5b87-415b-9892-10d2edbc1943Available on FDA.report

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
24208-430-03Opcon-A3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS37
24208-430-03Opcon-A1 in 1 CARTONSOLUTION/ DROPS17
24208-430-15Opcon-A15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS157
24208-430-15Opcon-A1 in 1 CARTONSOLUTION/ DROPS17
24208-430-30Opcon-A30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS307
24208-430-30Opcon-A1 in 1 CARTONSOLUTION/ DROPS17
24208-430-45Opcon-A15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS157
24208-430-45Opcon-A2 in 1 CARTONSOLUTION/ DROPS27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-430-15ML - Milliliter24208-430f8a4f895-d79c-44b4-85db-5e7720d6589f12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787DOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
PHENIRAMINE MALEATEACTIVE INGREDIENTNYW905655BOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
NAPHAZOLINEACTIVE MOIETYH231GF11BVOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
PHENIRAMINEACTIVE MOIETY134FM9ZZ6MOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4OPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3
WATERINACTIVE INGREDIENT059QF0KO0ROPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-430OPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7Current NDC, Legacy NDC, 8 package rows20231215_90a05c13-5b87-415b-9892-10d2edbc1943.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Opcon-ANAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEBausch & Lomb Incorporated2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52026-03-20WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
EYE ALLERGY RELIEFNAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATECVS PHARMACY253130b4-a23b-43a0-b125-0fa5bd01b2b62026-01-15WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
Eye Allergy ReliefPHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDEWalgreen Companyddd892af-56d0-4755-af87-807ea8f8e9ca2026-01-14WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
Eye Allergy ReliefPHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDETarget Corporation806ad1b6-0de7-4e9a-be86-475c0ef2c3402025-03-28WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
Eye Allergy ReliefPHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDERite Aid Corporation6043040e-3206-40dd-aa87-940b1a84a4962024-07-22WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
Opcon-ANAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEBausch & Lomb Incorporated90a05c13-5b87-415b-9892-10d2edbc19432023-12-14WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
ndc (package): 24208-430-03
ndc (product): 24208-430
ndc11 (package): 24208043003
Eye Allergy ReliefPHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDEWal-Mart Stores Inc873a072f-159b-44b8-aad8-33963d961afb2021-04-05WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
Eye Allergy ReliefPHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDEDOLGENCORP, LLC82a99ff3-4f57-42e6-82f4-769d6418be7c2020-01-27WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043704naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic SolutionPSN90a05c13-5b87-415b-9892-10d2edbc19437
1043708Opcon-A 0.02675 % / 0.315 % Ophthalmic SolutionPSN90a05c13-5b87-415b-9892-10d2edbc19437
1043708naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic Solution [Opcon-A]SBD90a05c13-5b87-415b-9892-10d2edbc19437
1043704naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic SolutionSCD90a05c13-5b87-415b-9892-10d2edbc19437
1043704naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic SolutionSY90a05c13-5b87-415b-9892-10d2edbc19437
1043704naphazoline HCl 0.027 % / pheniramine maleate 0.315 % Ophthalmic SolutionSY90a05c13-5b87-415b-9892-10d2edbc19437
1043708Opcon A (naphazoline hydrochloride 0.027 % / pheniramine maleate 0.315 % ) Ophthalmic SolutionSY90a05c13-5b87-415b-9892-10d2edbc19437
1043708Opcon-A (naphazoline hydrochloride 0.02675 % / pheniramine maleate 0.315 % ) Ophthalmic SolutionSY90a05c13-5b87-415b-9892-10d2edbc19437

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-430-03242080430031 BOTTLE, DROPPER in 1 CARTON (24208-430-03) > 3 mL in 1 BOTTLE, DROPPER1994-08-060000-00-00NoNoCurrent