FDA.reportPublic FDA data

Eye Allergy Relief

Product NDC
55910-552
11-digit product format
559100552
Labeler code
55910
Product ID
55910-552_cd63fc06-3ea0-4e38-a744-976ada520fdd
Type
HUMAN OTC DRUG
Nonproprietary name
Pheniramine Maleate and Naphazoline Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
DOLGENCORP, LLC
Application
NDA020065
Marketing category
NDA
Marketing start
2015-07-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Eye Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMZ1131787D, NYW905655B
Rxcui1043704

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
55910-552-15Eye Allergy Relief1 in 1 CARTONSOLUTION/ DROPS13
55910-552-15Eye Allergy Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787DEYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
PHENIRAMINE MALEATEACTIVE INGREDIENTNYW905655BEYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
NAPHAZOLINEACTIVE MOIETYH231GF11BVEYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
PHENIRAMINEACTIVE MOIETY134FM9ZZ6MEYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBEYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOEYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0REYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-552EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]3Current NDC, Legacy NDC, 2 package rows20200128_82a99ff3-4f57-42e6-82f4-769d6418be7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043704naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic SolutionPSN82a99ff3-4f57-42e6-82f4-769d6418be7c3
1043704naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic SolutionSCD82a99ff3-4f57-42e6-82f4-769d6418be7c3
1043704naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic SolutionSY82a99ff3-4f57-42e6-82f4-769d6418be7c3
1043704naphazoline HCl 0.027 % / pheniramine maleate 0.315 % Ophthalmic SolutionSY82a99ff3-4f57-42e6-82f4-769d6418be7c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-552-15559100552151 BOTTLE, DROPPER in 1 CARTON (55910-552-15) / 15 mL in 1 BOTTLE, DROPPER2015-07-010000-00-00NoNoCurrent