FDA.reportPublic FDA data

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

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
Rxcui141859, 825321

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
0187-0994-20Zovirax1 in 1 CARTONCREAM110
0187-0994-20Zovirax0.9 g in 1 TUBECREAM0.910
0187-0994-45Zovirax5 g in 1 TUBECREAM510
0187-0994-45Zovirax1 in 1 CARTONCREAM110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0994-45GM - Gram0187-0994a62ee96a-7db5-4f2e-98a7-3e08ce52b70612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
acyclovirACTIVE INGREDIENTX4HES1O11FZOVIRAX (ACYCLOVIR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]4
acyclovirACTIVE MOIETYX4HES1O11FZOVIRAX (ACYCLOVIR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]4
Cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SZOVIRAX (ACYCLOVIR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]4
Mineral oilINACTIVE INGREDIENTT5L8T28FGPZOVIRAX (ACYCLOVIR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]4
PetrolatumINACTIVE INGREDIENT4T6H12BN9UZOVIRAX (ACYCLOVIR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]4
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2ZOVIRAX (ACYCLOVIR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]4
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JZOVIRAX (ACYCLOVIR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]4
WaterINACTIVE INGREDIENT059QF0KO0RZOVIRAX (ACYCLOVIR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0994ZOVIRAX (ACYCLOVIR) CREAM [BAUSCH HEALTH US, LLC]10Current NDC, Legacy NDC, 4 package rows20210420_125dbe4e-94ba-45bd-a714-f9c4b8e8b5c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141859acyclovir 5 % Topical CreamPSN125dbe4e-94ba-45bd-a714-f9c4b8e8b5c210
825321Zovirax 5 % Topical CreamPSN125dbe4e-94ba-45bd-a714-f9c4b8e8b5c210
825321acyclovir 50 MG/ML Topical Cream [Zovirax]SBD125dbe4e-94ba-45bd-a714-f9c4b8e8b5c210
141859acyclovir 50 MG/ML Topical CreamSCD125dbe4e-94ba-45bd-a714-f9c4b8e8b5c210
141859acyclovir 5 % Topical CreamSY125dbe4e-94ba-45bd-a714-f9c4b8e8b5c210
141859acycycloguanosine 50 MG/ML Topical CreamSY125dbe4e-94ba-45bd-a714-f9c4b8e8b5c210
825321acycycloguanosine 50 MG/ML Topical Cream [Zovirax]SY125dbe4e-94ba-45bd-a714-f9c4b8e8b5c210
825321Zovirax 5 % Topical CreamSY125dbe4e-94ba-45bd-a714-f9c4b8e8b5c210
825321Zovirax 50 MG/ML Topical CreamSY125dbe4e-94ba-45bd-a714-f9c4b8e8b5c210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-0994-20001870994201 in 1 CARTONHistorical
0187-0994-45001870994451 TUBE in 1 CARTON (0187-0994-45) / 5 g in 1 TUBE1 tube2002-12-300000-00-00NoNoCurrent