FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
42702-103
11-digit product format
427020103
Labeler code
42702
Product ID
42702-103_ff463c02-5533-c9ad-e053-6294a90a7035
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenylephrine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Paragon BioTeck, Inc.
Application
NDA203510
Marketing category
NDA
Marketing start
2013-04-15
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1234571, 1234579

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42702-103-052023-02-02C16284748780-1f386c649-fa82-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10% safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10%. PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10%, for topical ophthalmic use Initial U.S. Approval: 1939
42702-103-052023-01-30C16284748780-1f386c649-fa82-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10% safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10%. PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10%, for topical ophthalmic use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42702-103-05Phenylephrine Hydrochloride5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS514
42702-103-05Phenylephrine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42702-103-05ML - Milliliter42702-1035b40d1be-36e5-4cde-87a9-61f1c257dc6c12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]2
phenylephrineACTIVE MOIETY1WS297W6MVPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]2
boric acidINACTIVE INGREDIENTR57ZHV85D4PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]2
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]2
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RPHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42702-103PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [PARAGON BIOTECK, INC.]14Current NDC, Legacy NDC, 2 package rows20230810_a4d3fe20-f063-11e0-ac29-0002a5d5c51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234571phenylephrine HCl 10 % Ophthalmic SolutionPSNa4d3fe20-f063-11e0-ac29-0002a5d5c51b14
1234579phenylephrine HCl 2.5 % Ophthalmic SolutionPSNa4d3fe20-f063-11e0-ac29-0002a5d5c51b14
1234571phenylephrine hydrochloride 100 MG/ML Ophthalmic SolutionSCDa4d3fe20-f063-11e0-ac29-0002a5d5c51b14
1234579phenylephrine hydrochloride 25 MG/ML Ophthalmic SolutionSCDa4d3fe20-f063-11e0-ac29-0002a5d5c51b14
1234571phenylephrine hydrochloride 10 % Ophthalmic SolutionSYa4d3fe20-f063-11e0-ac29-0002a5d5c51b14
1234579phenylephrine hydrochloride 2.5 % Ophthalmic SolutionSYa4d3fe20-f063-11e0-ac29-0002a5d5c51b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42702-103-05427020103051 BOTTLE, DROPPER in 1 CARTON (42702-103-05) / 5 mL in 1 BOTTLE, DROPPER2013-04-150000-00-00NoNoCurrent