FDA.reportPublic FDA data

Ouai Anti-Dandruff

Product NDC
83058-0140
Requested package NDC
83058-0140-4
11-digit product format
830580140
Labeler code
83058
Product ID
83058-0140_edfb5cc4-b100-48b1-9794-81da599b2746
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
United Beauty Brands, LLC
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-11-17
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 mg/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage83058-014083058-0140-4IInactivated by FDA2026-09-14

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83058-0140-12026-01-29C16284748780-149896155-bcf2-586f-e063-e6dba90add90Ouai Anti-Dandruff Shampoo
83058-0140-42026-01-29C16284748780-149896155-bcf2-586f-e063-e6dba90add90Ouai Anti-Dandruff Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83058-0140-1Ouai Anti-Dandruff300 mL in 1 BOTTLE, PLASTICSHAMPOO3002
83058-0140-4Ouai Anti-Dandruff30 mL in 1 TUBESHAMPOO302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83058-0140OUAI ANTI-DANDRUFF (SALICYLIC ACID) SHAMPOO [UNITED BEAUTY BRANDS, LLC]2Legacy NDC, 2 package rows20240119_10d146c2-7108-43c0-9f10-726d14cc9433.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83058-0140-48305801400430 mL in 1 TUBE (83058-0140-4) 30 ml2022-11-170000-00-00NoNoCurrent