FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197312, 209977

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

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