Naphazoline HCI And Pheniramine Maleate

Product NDC: 59390-177
11-digit product format: 593900177
Labeler code: 59390
Product ID: 59390-177_b78fd969-ee4c-0ea0-e053-2a95a90a480d
Type: HUMAN OTC DRUG
Nonproprietary name: NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Altaire Pharmaceuticals Inc.
Application: ANDA078208
Marketing category: ANDA
Marketing start: 2010-10-06
Substance: NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength: .27; 3.15 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC			2010-09-27

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naphazoline HCI And Pheniramine Maleate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPHAZOLINE HYDROCHLORIDE	.27 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043704	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
5649c6e2-966f-44d9-b57e-5bb988eb373d	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	Strength	SPL version
59390-177-13	Naphazoline HCI And Pheniramine Maleate	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPHAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	MZ1131787D	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1
PHENIRAMINE MALEATE	ACTIVE INGREDIENT	NYW905655B	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1
NAPHAZOLINE	ACTIVE MOIETY	H231GF11BV	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1
PHENIRAMINE	ACTIVE MOIETY	134FM9ZZ6M	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59390-177	NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 1 package rows	20201229_5649c6e2-966f-44d9-b57e-5bb988eb373d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naphazoline HCI And Pheniramine Maleate	NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE	Altaire Pharmaceuticals Inc.	5649c6e2-966f-44d9-b57e-5bb988eb373d	2020-12-28	Warnings	Exact identifier application applno (ANDA): 078208 application number: ANDA078208 ndc (product): 59390-177

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	5649c6e2-966f-44d9-b57e-5bb988eb373d	4
1043704	naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic Solution	SCD	5649c6e2-966f-44d9-b57e-5bb988eb373d	4
1043704	naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic Solution	SY	5649c6e2-966f-44d9-b57e-5bb988eb373d	4
1043704	naphazoline HCl 0.027 % / pheniramine maleate 0.315 % Ophthalmic Solution	SY	5649c6e2-966f-44d9-b57e-5bb988eb373d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59390-177-13	59390017713	15 mL in 1 BOTTLE, DROPPER (59390-177-13)	15 ml	2010-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naphazoline HCI 0.027% & Pheniramine Maleate 0.315% Ophthalmic Solution, USP	Altaire Pharmaceuticals Inc.	2020-12-28	HUMAN OTC DRUG LABEL	4