FDA.reportPublic FDA data

Fresh Clear

Manufacturer
Allergan, Inc.
Effective date
2019-02-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 20:46:20

Label at a glance#

ProductFresh Clear
Active ingredientphenylephrine hydrochloride
Label structure2 sections

Label contents#

Full prescribing information#

Principal Display Panel- 1.2% / 1.4% 15 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRESHCLEAR®

Fenilefrina,
Alcohol Polivinílico
Solución estéril

0.12 % / 1.4 %

Caja con frasco gotero con 15 mL

®ALLERGAN

FRESHCLEAR® Fenilefrina, Alcohol Polivinílico Solución estéril 0.12 % / 1.4 % Caja con frasco gotero con 15 mL ®ALLERGANFRESHCLEAR® Fenilefrina, Alcohol Polivinílico Solución estéril 0.12 % / 1.4 % Caja con frasco gotero con 15 mL ®ALLERGAN

Principal Display Panel - 0.12% 15 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AllerganTM

FRESHCLEAR® 

FENILEFRINA
CLORHIDRATO 0,12%

Solución
Oftálmica

Estéril 15 mL

ALLERGAN™ Rx phenylephrine hydrochloride; polyvinyl alcohol Fresh Clear® 15 mL sterileALLERGAN™ Rx phenylephrine hydrochloride; polyvinyl alcohol Fresh Clear® 15 mL sterile

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1547926phenylephrine 1.2 MG/mL Ophthalmic SolutionPSN4
1547926phenylephrine hydrochloride 1.2 MG/ML Ophthalmic SolutionSCD4
1547926phenylephrine hydrochloride 0.12 % Ophthalmic SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-0000-01Fresh Clear15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
0023-0000-01Fresh Clear1 in 1 CARTONSOLUTION/ DROPS14
0023-0000-02Fresh Clear3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS34
0023-0000-02Fresh Clear1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-0000FRESH CLEAR (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.]44 package rows20230115_cabd1f56-e265-41e3-a703-29f875460536.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0023-00000023-0000-01, 0023-0000-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
phenylephrine hydrochloride04JA59TNSJACTIB
edetate disodium7FLD91C86KIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
sodium phosphate, dibasic, heptahydrate70WT22SF4BIACT
sodium phosphate, monobasic, monohydrate593YOG76RNIACT
sodium acetate4550K0SC9BIACT
sodium thiosulfateHX1032V43MIACT
water059QF0KO0RIACT
benzalkonium chlorideF5UM2KM3W7IACT
hydrochloric acidQTT17582CBIACT
sodium hydroxide55X04QC32IIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
21d4b039-132e-470a-addd-22b3737e5a02cabd1f56-e265-41e3-a703-29f8754605362019-02-01Exact identifier
spl id: 21d4b039-132e-470a-addd-22b3737e5a02
spl set id: cabd1f56-e265-41e3-a703-29f875460536

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.