Home NDC 0187-5104-01 Xerese
Product NDC 0187-5104
Requested package NDC 0187-5104-01
11-digit product format 001875104
Labeler code 0187
Product ID 0187-5104_a4efb63c-e7bf-43da-bbfe-463f672cb1bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir and Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Bausch Health US LLC
Application NDA022436
Marketing category NDA
Marketing start 2009-07-31
Substance ACYCLOVIR; HYDROCORTISONE
Active strength 50; 10 mg/g; mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
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 1 .
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 N022436-001 XERESE ACYCLOVIR; HYDROCORTISONE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022436-001 XERESE 5%;1% CREAM / TOPICAL RLD, RS 2009-07-31 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022436-001 7223387 2022-11-13 U-1006 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022436-001 7223387 2022-11-13 U-1484 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022436-001 7223387 2022-11-13 U-1006 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022436-001 7223387 2022-11-13 U-1484 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022436-001 7223387 2022-11-13 U-1006 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022436-001 7223387 2022-11-13 U-1484 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022436-001 7223387 2022-11-13 U-1006 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022436-001 7223387 2022-11-13 U-1484 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022436-001 7223387 2022-11-13 U-1484 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022436-001 7223387 2022-11-13 U-1006 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022436-001 7223387 2022-11-13 U-1006 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022436-001 7223387 2022-11-13 U-1484 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022436-001 7223387 2022-11-13 U-1006 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022436-001 7223387 2022-11-13 U-1484 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022436-001 7223387 2022-11-13 U-1006 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022436-001 7223387 2022-11-13 U-1484 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022436-001 7223387 2022-11-13 U-1006 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022436-001 7223387 2022-11-13 U-1484 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022436-001 7223387 2022-11-13 U-1006 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022436-001 7223387 2022-11-13 U-1484 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022436-001 7223387 2022-11-13 U-1006 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022436-001 7223387 2022-11-13 U-1484 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022436-001 7223387 2022-11-13 U-1006 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022436-001 7223387 2022-11-13 U-1484 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022436-001 7223387 2022-11-13 U-1006 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022436-001 7223387 2022-11-13 U-1484 Drug product ea99ee380514…2022-09-29 23:25 UTC 2022-09 N022436-001 7223387 2022-11-13 U-1006 Drug product e64feba35796…2022-09-29 23:25 UTC 2022-09 N022436-001 7223387 2022-11-13 U-1484 Drug product e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022436-001 7223387 2022-11-13 U-1484 Drug product cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022436-001 7223387 2022-11-13 U-1006 Drug product cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Xerese
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 50 mg/g HYDROCORTISONE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X4HES1O11F Internal UNII lookup WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998422 Internal RxNorm lookup 998426 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-5104 XERESE (ACYCLOVIR AND HYDROCORTISONE) CREAM [BAUSCH HEALTH US LLC] 7 Current NDC, Legacy NDC, 4 package rows 20200905_3b6ac164-0f1e-4f36-94a1-1fdb07d710f5.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 0187-5104-01 00187510401 1 TUBE in 1 CARTON (0187-5104-01) / 5 g in 1 TUBE 1 tube 2009-07-31 0000-00-00 No No Current