FDA.reportPublic FDA data

Staquis

Manufacturer
Pharmacia & Upjohn Company LLC | Pfizer Inc
Effective date
2023-06-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:51:00

Label at a glance#

ProductStaquis
Active ingredientCRISABOROLE
Label structure3 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - Shipping Label – Label 0009-2211-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tubo con 30 g

Staquis®

Crisaborol Ungüento 2%

Vía de administración: Cutánea.

Lote:
Caducidad:

PRINCIPAL DISPLAY PANEL - Shipping Label – Label 0009-2211-30
PRINCIPAL DISPLAY PANEL - Shipping Label – Label 0009-2211-30

PRINCIPAL DISPLAY PANEL - Shipping Label – Carton 0009-2211-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Staquis®
Crisaborol Ungüento 2%

Caja con tubo con 30 g

Vía de administración: Cutánea.

PRINCIPAL DISPLAY PANEL - Shipping Label – Carton 0009-2211-30
PRINCIPAL DISPLAY PANEL - Shipping Label – Carton 0009-2211-30

PRINCIPAL DISPLAY PANEL - Shipping Label – Label 0009-2211-12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Staquis®
30 g
Rx only

(crisaborole) ointment 2%

For Topical Use Only.

Not for ophthalmic, oral, or intravaginal use.

Lot
EXP

PRINCIPAL DISPLAY PANEL - Shipping Label – Label 0009-2211-12
PRINCIPAL DISPLAY PANEL - Shipping Label – Label 0009-2211-12

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
752945ff-66b7-44e5-839e-da21385bcbecProduct name120170309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-2211-12Staquis30 g in 1 TUBEOINTMENT303
0009-2211-12Staquis1 in 1 CARTONOINTMENT13
0009-2211-30Staquis30 g in 1 TUBEOINTMENT303
0009-2211-30Staquis1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-2211STAQUIS (CRISABOROLE) OINTMENT [PHARMACIA & UPJOHN COMPANY LLC]34 package rows20230623_e7d98df8-b658-45fa-9464-62d9373b1cc8.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0009-22110009-2211-30, 0009-2211-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CRISABOROLEQ2R47HGR7PACTIB
PETROLATUM4T6H12BN9UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PARAFFINI9O0E3H2ZEIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
EDETATE CALCIUM DISODIUM25IH6R4SGFIACT

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
f72df1ab-828a-4d73-b4df-cb0f2fed9ba2e7d98df8-b658-45fa-9464-62d9373b1cc82023-06-21Exact identifier
spl id: f72df1ab-828a-4d73-b4df-cb0f2fed9ba2
spl set id: e7d98df8-b658-45fa-9464-62d9373b1cc8

Reported adverse events (FAERS/openFDA)#

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