FDA.reportPublic FDA data

ZOVIRAX

Product NDC
42254-149
11-digit product format
422540149
Labeler code
42254
Product ID
42254-149_0da14760-1131-4936-9a42-c40fc4db5cd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
NDA021478
Marketing category
NDA
Marketing start
2004-10-29
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-149-052019-09-24C16284748780-19350213a-3c26-c013-e053-90daa90a1393ZOVIRAX ® (acyclovir) Cream 5% USE ONLY FOR COLD SORES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-149-05ZOVIRAX5 g in 1 TUBECREAM51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-149-05GM - Gram42254-149763eb6bf-b592-4ffe-8867-12cb9622317512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FZOVIRAX (ACYCLOVIR) CREAM [REBEL DISTRIBUTORS CORP]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FZOVIRAX (ACYCLOVIR) CREAM [REBEL DISTRIBUTORS CORP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SZOVIRAX (ACYCLOVIR) CREAM [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPZOVIRAX (ACYCLOVIR) CREAM [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UZOVIRAX (ACYCLOVIR) CREAM [REBEL DISTRIBUTORS CORP]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ZOVIRAX (ACYCLOVIR) CREAM [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZOVIRAX (ACYCLOVIR) CREAM [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZOVIRAX (ACYCLOVIR) CREAM [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RZOVIRAX (ACYCLOVIR) CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-149ZOVIRAX (ACYCLOVIR) CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120411_0da14760-1131-4936-9a42-c40fc4db5cd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141859acyclovir 5 % Topical CreamPSN0da14760-1131-4936-9a42-c40fc4db5cd01
825321Zovirax 5 % Topical CreamPSN0da14760-1131-4936-9a42-c40fc4db5cd01
825321acyclovir 50 MG/ML Topical Cream [Zovirax]SBD0da14760-1131-4936-9a42-c40fc4db5cd01
141859acyclovir 50 MG/ML Topical CreamSCD0da14760-1131-4936-9a42-c40fc4db5cd01
141859acyclovir 5 % Topical CreamSY0da14760-1131-4936-9a42-c40fc4db5cd01
141859acycycloguanosine 50 MG/ML Topical CreamSY0da14760-1131-4936-9a42-c40fc4db5cd01
825321acycycloguanosine 50 MG/ML Topical Cream [Zovirax]SY0da14760-1131-4936-9a42-c40fc4db5cd01
825321Zovirax 5 % Topical CreamSY0da14760-1131-4936-9a42-c40fc4db5cd01
825321Zovirax 50 MG/ML Topical CreamSY0da14760-1131-4936-9a42-c40fc4db5cd01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-149-05422540149055 g in 1 TUBE5 gHistorical