Home NDC 0187-0002 Bryhali
Product NDC 0187-0002
11-digit product format 001870002
Labeler code 0187
Product ID 0187-0002_e14757d5-86ff-41a8-8bde-14065af6899e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name halobetasol propionate
Dosage form LOTION
Route TOPICAL
Labeler Bausch Health US, LLC
Application NDA209355
Marketing category NDA
Marketing start 2018-11-06
Substance HALOBETASOL PROPIONATE
Active strength .1 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 42 .
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 N209355-001 BRYHALI HALOBETASOL PROPIONATE 0.01% LOTION / TOPICAL RLD, RS 2018-11-06
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209355-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 N209355-001 11839656 2031-11-02 U-2625 2024-01-05 N209355-001 11957753 2031-11-02 Drug product 2024-05-10 N209355-001 11986527 2031-11-02 U-2625 2024-06-13 N209355-001 12076403 2031-11-02 Drug product 2024-09-24 N209355-001 8809307 2031-11-02 Drug product 2019-05-13
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 · 42 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 2026-08-18 06:07:40 2026-07 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209355-001 BRYHALI 0.01% LOTION / TOPICAL RLD, RS 2018-11-06 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 4 · 146 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209355-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209355-001 11839656 2031-11-02 U-2625 2024-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209355-001 11957753 2031-11-02 Drug product 2024-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209355-001 11986527 2031-11-02 U-2625 2024-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209355-001 12076403 2031-11-02 Drug product 2024-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209355-001 8809307 2031-11-02 Drug product 2019-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209355-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209355-001 11839656 2031-11-02 U-2625 2024-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209355-001 11957753 2031-11-02 Drug product 2024-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209355-001 11986527 2031-11-02 U-2625 2024-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209355-001 12076403 2031-11-02 Drug product 2024-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209355-001 8809307 2031-11-02 Drug product 2019-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209355-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209355-001 11839656 2031-11-02 U-2625 2024-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209355-001 11957753 2031-11-02 Drug product 2024-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209355-001 11986527 2031-11-02 U-2625 2024-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209355-001 12076403 2031-11-02 Drug product 2024-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209355-001 8809307 2031-11-02 Drug product 2019-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209355-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209355-001 11839656 2031-11-02 U-2625 2024-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209355-001 11957753 2031-11-02 Drug product 2024-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209355-001 11986527 2031-11-02 U-2625 2024-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209355-001 12076403 2031-11-02 Drug product 2024-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209355-001 8809307 2031-11-02 Drug product 2019-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209355-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209355-001 11839656 2031-11-02 U-2625 2024-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209355-001 11957753 2031-11-02 Drug product 2024-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209355-001 11986527 2031-11-02 U-2625 2024-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209355-001 12076403 2031-11-02 Drug product 2024-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209355-001 8809307 2031-11-02 Drug product 2019-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209355-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209355-001 11839656 2031-11-02 U-2625 2024-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209355-001 11957753 2031-11-02 Drug product 2024-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209355-001 11986527 2031-11-02 U-2625 2024-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209355-001 12076403 2031-11-02 Drug product 2024-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209355-001 8809307 2031-11-02 Drug product 2019-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209355-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209355-001 11839656 2031-11-02 U-2625 2024-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209355-001 11957753 2031-11-02 Drug product 2024-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209355-001 11986527 2031-11-02 U-2625 2024-06-13 03ed91905a0d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Bryhali
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOBETASOL PROPIONATE .1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 91A0K1TY3Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2101710 Internal RxNorm lookup 2101715 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 0187-0002 BRYHALI (HALOBETASOL PROPIONATE) LOTION [BAUSCH HEALTH US, LLC] 4 Current NDC, Legacy NDC, 6 package rows 20200805_d4bbb66a-3f9d-4091-b1b0-1cbc908432d3.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.
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 0187-0002-01 00187000201 1 TUBE in 1 CARTON (0187-0002-01) / 100 g in 1 TUBE 1 tube 2018-11-06 0000-00-00 No No Current 0187-0002-03 00187000203 1 TUBE in 1 CARTON (0187-0002-03) / 3 g in 1 TUBE 1 tube 2018-11-06 0000-00-00 Yes No Current 0187-0002-60 00187000260 1 TUBE in 1 CARTON (0187-0002-60) / 60 g in 1 TUBE 1 tube 2018-11-06 0000-00-00 No No Current