FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
0065-0349
11-digit product format
000650349
Labeler code
0065
Product ID
0065-0349_c9ffa382-0391-4947-9638-dd7d648a6e38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA207926
Marketing category
NDA
Marketing start
2015-01-15
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
25 mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenylephrine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1234571, 1234579

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0349-04Phenylephrine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153
0065-0349-04Phenylephrine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS13
0065-0349-05Phenylephrine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS13
0065-0349-05Phenylephrine Hydrochloride2 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0349-04ML - Milliliter0065-0349be4d46b5-2856-41bf-8e13-5f85ceadbaa012025-03-04
0065-0349-05ML - Milliliter0065-03494e1d3d87-e63b-400c-aefd-6ddc3eacdcf312025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0349PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [ALCON LABORATORIES, INC.]3Current NDC, 4 package rows20250403_cacbb3fd-1c03-4523-a1bf-0ccc4be102ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234571phenylephrine HCl 10 % Ophthalmic SolutionPSNcacbb3fd-1c03-4523-a1bf-0ccc4be102ef3
1234579phenylephrine HCl 2.5 % Ophthalmic SolutionPSNcacbb3fd-1c03-4523-a1bf-0ccc4be102ef3
1234571phenylephrine hydrochloride 100 MG/ML Ophthalmic SolutionSCDcacbb3fd-1c03-4523-a1bf-0ccc4be102ef3
1234579phenylephrine hydrochloride 25 MG/ML Ophthalmic SolutionSCDcacbb3fd-1c03-4523-a1bf-0ccc4be102ef3
1234571phenylephrine hydrochloride 10 % Ophthalmic SolutionSYcacbb3fd-1c03-4523-a1bf-0ccc4be102ef3
1234579phenylephrine hydrochloride 2.5 % Ophthalmic SolutionSYcacbb3fd-1c03-4523-a1bf-0ccc4be102ef3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0065-0349-04000650349041 BOTTLE, DROPPER in 1 CARTON (0065-0349-04) / 15 mL in 1 BOTTLE, DROPPER2024-10-28NoNoHistorical
0065-0349-05000650349051 BOTTLE, DROPPER in 1 CARTON (0065-0349-05) / 2 mL in 1 BOTTLE, DROPPER2024-10-28NoNoHistorical