Zovirax

Product NDC
0187-0993
11-digit product format
001870993
Labeler code
0187
Product ID
0187-0993_e880f5a1-cf2f-4ace-87b3-e79c59490440
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA018604
Marketing category
NDA
Marketing start
1982-03-29
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018604-001ZOVIRAXACYCLOVIR5%OINTMENT / TOPICALABRLD, RS1982-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018604-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-293f01610625f2…
2019-09-15 20:21 UTC2019-09N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018604-001ZOVIRAX5%OINTMENT / TOPICALABRLD, RS1982-03-29e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018604-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018604-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018604-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018604-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018604-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018604-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018604-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018604-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018604-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018604-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018604-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018604-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018604-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018604-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018604-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018604-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018604-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018604-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018604-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018604-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018604-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018604-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018604-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018604-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018604-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018604-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018604-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018604-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018604-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018604-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018604-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018604-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018604-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018604-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018604-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018604-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018604-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018604-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018604-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018604-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Zovirax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X4HES1O11FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197312Internal RxNorm lookup
209977Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50278e0e-da1e-45ee-9fcb-672b2a219911Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-0993-95Zovirax30 g in 1 TUBEOINTMENT306
0187-0993-95Zovirax1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0993-95GM - Gram0187-0993323acc94-47ca-4835-ad60-3c6dc40d67da12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
acyclovirACTIVE INGREDIENTX4HES1O11FZOVIRAX (ACYCLOVIR) OINTMENT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
acyclovirACTIVE MOIETYX4HES1O11FZOVIRAX (ACYCLOVIR) OINTMENT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AZOVIRAX (ACYCLOVIR) OINTMENT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0993ZOVIRAX (ACYCLOVIR) OINTMENT [BAUSCH HEALTH US, LLC]6Current NDC, Legacy NDC, 2 package rows20210112_50278e0e-da1e-45ee-9fcb-672b2a219911.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRACTAVIS PHARMA, INC.b360a808-a24d-4f3c-89a7-9941422d17d62020-10-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 018604
application number: NDA018604
ZoviraxACYCLOVIRBausch Health US, LLC50278e0e-da1e-45ee-9fcb-672b2a2199112020-10-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 018604
application number: NDA018604
ndc (product): 0187-0993

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSN50278e0e-da1e-45ee-9fcb-672b2a2199116
209977Zovirax 5 % Topical OintmentPSN50278e0e-da1e-45ee-9fcb-672b2a2199116
209977acyclovir 0.05 MG/MG Topical Ointment [Zovirax]SBD50278e0e-da1e-45ee-9fcb-672b2a2199116
197312acyclovir 0.05 MG/MG Topical OintmentSCD50278e0e-da1e-45ee-9fcb-672b2a2199116
197312acyclovir 5 % Topical OintmentSY50278e0e-da1e-45ee-9fcb-672b2a2199116
197312acyclovir 50 MG per 1 GM Topical OintmentSY50278e0e-da1e-45ee-9fcb-672b2a2199116
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY50278e0e-da1e-45ee-9fcb-672b2a2199116
209977acycycloguanosine 0.05 MG/MG Topical Ointment [Zovirax]SY50278e0e-da1e-45ee-9fcb-672b2a2199116
209977Zovirax 0.05 MG/MG Topical OintmentSY50278e0e-da1e-45ee-9fcb-672b2a2199116
209977Zovirax 5 % Topical OintmentSY50278e0e-da1e-45ee-9fcb-672b2a2199116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-0993-95001870993951 TUBE in 1 CARTON (0187-0993-95) / 30 g in 1 TUBE1 tube1982-03-290000-00-00NoNoCurrent