Nuvileo Skin Perfecting Acne

Product NDC
58133-500
11-digit product format
581330500
Labeler code
58133
Product ID
58133-500_230eff3b-ad49-4729-8b6c-2bd56e15b61b
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosmetic Specialty Labs, Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-30
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58133-500IInactivated by FDA2026-10-21
excluded packagepackage58133-50058133-500-02IInactivated by FDA2026-10-21

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58133-500-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58133-500-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58133-500-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58133-500-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58133-500-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58133-500-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58133-500-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58133-500-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58133-500-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58133-500-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58133-500-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58133-500-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage58133-500-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage58133-500-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage58133-500-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage58133-500-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58133-500-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58133-500-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58133-500-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58133-500-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58133-500-029bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-500-022020-01-31C16284748780-19d75b9d0-f6fa-f424-e053-dadaa90a57ceNuviléo™ Skin Perfecting Acne Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-500-02Nuvileo Skin Perfecting Acne60 mL in 1 TUBECREAM601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Salicylic AcidACTIVE MOIETYO414PZ4LPZNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0NUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
AllantoinINACTIVE INGREDIENT344S277G0ZNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Aloe Vera WholeINACTIVE INGREDIENTKIZ4X2EHYXNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
C13-14 IsoparaffinINACTIVE INGREDIENTE4F12ROE70NUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438UNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Citrus Maxima Fruit Rind OilINACTIVE INGREDIENT8U3877WD44NUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
CyclomethiconeINACTIVE INGREDIENTNMQ347994ZNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Ethylhexyl StearateINACTIVE INGREDIENTEG3PA2K3K5NUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Hydrastis Canadensis WholeINACTIVE INGREDIENTR763EBH88TNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Laureth-7INACTIVE INGREDIENTZ95S6G8201NUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Olive OilINACTIVE INGREDIENT6UYK2W1W1ENUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Panax Quinquefolius WholeINACTIVE INGREDIENT0P067WOA1XNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
Passiflora Incarnata Flowering TopINACTIVE INGREDIENTCLF5YFS11ONUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
TrolamineINACTIVE INGREDIENT9O3K93S3TKNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RNUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-500NUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 1 package rows20150721_731c60f5-8b27-41d6-baaf-1f4723e92aa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658308Nuvileo 2 % Topical CreamPSN731c60f5-8b27-41d6-baaf-1f4723e92aa91
317152salicylic acid 2 % Topical CreamPSN731c60f5-8b27-41d6-baaf-1f4723e92aa91
1658308salicylic acid 20 MG/ML Topical Cream [Nuvileo]SBD731c60f5-8b27-41d6-baaf-1f4723e92aa91
317152salicylic acid 20 MG/ML Topical CreamSCD731c60f5-8b27-41d6-baaf-1f4723e92aa91
1658308Nuvileo 2 % Topical CreamSY731c60f5-8b27-41d6-baaf-1f4723e92aa91
317152salicylic acid 2 % Topical CreamSY731c60f5-8b27-41d6-baaf-1f4723e92aa91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58133-500-025813305000260 mL in 1 TUBE60 mlHistorical