Home NDC 0187-0994 Zovirax
Product NDC 0187-0994
11-digit product format 001870994
Labeler code 0187
Product ID 0187-0994_beac4f87-cacc-4345-be9e-b105f6db7ee2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acyclovir
Dosage form CREAM
Route TOPICAL
Labeler Bausch Health US, LLC
Application NDA021478
Marketing category NDA
Marketing start 2002-12-30
Substance ACYCLOVIR
Active strength 50 mg/g
Pharmacologic classes 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N021478-001 ZOVIRAX ACYCLOVIR 5% CREAM / TOPICAL AB RLD 2002-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021478-001 AB
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 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD, RS 2002-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD, RS 2002-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD, RS 2002-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD, RS 2002-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021478-001 ZOVIRAX 5% CREAM / TOPICAL AB RLD 2002-12-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zovirax
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X4HES1O11F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 141859 Internal RxNorm lookup 825321 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 0187-0994 ZOVIRAX (ACYCLOVIR) CREAM [BAUSCH HEALTH US, LLC] 10 Current NDC, Legacy NDC, 4 package rows 20210420_125dbe4e-94ba-45bd-a714-f9c4b8e8b5c2.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 · 2 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 0187-0994-20 00187099420 1 in 1 CARTON Historical 0187-0994-45 00187099445 1 TUBE in 1 CARTON (0187-0994-45) / 5 g in 1 TUBE 1 tube 2002-12-30 0000-00-00 No No Current