Home NDC 55724-211 Eucrisa
Product NDC 55724-211
11-digit product format 557240211
Labeler code 55724
Product ID 55724-211_e5457495-d465-4c0a-a1ea-603c4c5823fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name crisaborole
Dosage form OINTMENT
Route TOPICAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA207695
Marketing category NDA
Marketing start 2017-01-30
Substance CRISABOROLE
Active strength 20 mg/g
Pharmacologic classes Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207695-001 EUCRISA CRISABOROLE 2% OINTMENT / TOPICAL RLD, RS 2016-12-14
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207695-001 8501712 2027-02-16 U-1932 2017-01-12 N207695-001 9682092 2027-02-16 U-1932 2017-07-14 N207695-001 8501712*PED 2027-08-16 Pediatric extension N207695-001 9682092*PED 2027-08-16 Pediatric extension N207695-001 8039451 2029-06-29 Drug substance, Drug product 2017-01-12 N207695-001 8039451*PED 2029-12-29 Pediatric extension N207695-001 8168614 2030-01-20 U-1932 2017-01-12 N207695-001 8168614*PED 2030-07-20 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N207695-001 D-191 2026-04-03
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207695-001 EUCRISA 2% OINTMENT / TOPICAL RLD, RS 2016-12-14 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 9 · 328 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N207695-001 8501712 2027-02-16 U-1932 2017-01-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207695-001 9682092 2027-02-16 U-1932 2017-07-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207695-001 8501712*PED 2027-08-16 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207695-001 9682092*PED 2027-08-16 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207695-001 8039451 2029-06-29 Drug substance, Drug product 2017-01-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207695-001 8039451*PED 2029-12-29 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207695-001 8168614 2030-01-20 U-1932 2017-01-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207695-001 8168614*PED 2030-07-20 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207695-001 8501712 2027-02-16 U-1932 2017-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207695-001 9682092 2027-02-16 U-1932 2017-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207695-001 8501712*PED 2027-08-16 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207695-001 9682092*PED 2027-08-16 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207695-001 8039451 2029-06-29 Drug substance, Drug product 2017-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207695-001 8039451*PED 2029-12-29 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207695-001 8168614 2030-01-20 U-1932 2017-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207695-001 8168614*PED 2030-07-20 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207695-001 8501712 2027-02-16 U-1932 2017-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207695-001 9682092 2027-02-16 U-1932 2017-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207695-001 8501712*PED 2027-08-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207695-001 9682092*PED 2027-08-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207695-001 8039451 2029-06-29 Drug substance, Drug product 2017-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207695-001 8039451*PED 2029-12-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207695-001 8168614 2030-01-20 U-1932 2017-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207695-001 8168614*PED 2030-07-20 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207695-001 8501712 2027-02-16 U-1932 2017-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207695-001 9682092 2027-02-16 U-1932 2017-07-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207695-001 8501712*PED 2027-08-16 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207695-001 9682092*PED 2027-08-16 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207695-001 8039451 2029-06-29 Drug substance, Drug product 2017-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207695-001 8039451*PED 2029-12-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207695-001 8168614 2030-01-20 U-1932 2017-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207695-001 8168614*PED 2030-07-20 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207695-001 8501712 2027-02-16 U-1932 2017-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207695-001 9682092 2027-02-16 U-1932 2017-07-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207695-001 8501712*PED 2027-08-16 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207695-001 9682092*PED 2027-08-16 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207695-001 8039451 2029-06-29 Drug substance, Drug product 2017-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207695-001 8039451*PED 2029-12-29 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207695-001 8168614 2030-01-20 U-1932 2017-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207695-001 8168614*PED 2030-07-20 Pediatric extension 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 84 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Eucrisa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CRISABOROLE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q2R47HGR7P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1865957 Internal RxNorm lookup 1865962 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55724-211 EUCRISA (CRISABOROLE) OINTMENT [PFIZER LABORATORIES DIV PFIZER INC] 12 Current NDC, Legacy NDC, 8 package rows 20250110_609b77de-1ca3-4783-b8f5-01a9c0f1d77d.zip
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eucrisa CRISABOROLE Pfizer Laboratories Div Pfizer Inc 609b77de-1ca3-4783-b8f5-01a9c0f1d77d 2025-09-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 207695 application number: NDA207695 ndc (product): 55724-211
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55724-211-11 55724021111 1 TUBE in 1 CARTON (55724-211-11) / 100 g in 1 TUBE 1 tube 2017-01-30 0000-00-00 No No Current 55724-211-21 55724021121 1 TUBE in 1 CARTON (55724-211-21) / 60 g in 1 TUBE 1 tube 2017-01-30 0000-00-00 No No Current 55724-211-23 55724021123 1 TUBE in 1 CARTON (55724-211-23) / 60 g in 1 TUBE 1 tube 2017-01-30 0000-00-00 No No Current 55724-211-42 55724021142 6 TUBE in 1 CARTON (55724-211-42) / 2.5 g in 1 TUBE 6 tube 2017-01-30 0000-00-00 No No Current