Acne wash facial cleanser Tea tree oil

Product NDC
57337-081
Requested package NDC
57337-081-01
11-digit product format
573370081
Labeler code
57337
Product ID
57337-081_2c6b3ecc-03e4-48d0-e063-6394a90afac2
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Rejoice International Corp.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-01
Substance
SALICYLIC ACID
Active strength
2 g/200mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-08157337-081-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-08157337-081-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Acne wash facial cleanser Tea tree oil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/200mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038982Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
39043ea1-6552-717a-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-081-01Acne wash facial cleanser Tea tree oil200 mL in 1 BOTTLELIQUID2007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-081ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) LIQUID [REJOICE INTERNATIONAL CORP.]7Current NDC, Legacy NDC, 1 package rows20250125_39043ea1-6552-717a-e054-00144ff8d46c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 45 of 54 · 1,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AL00761 Alba Botanica Acnedote Face and Body ScrubSALICYLIC ACIDThe Hain Celestial Group, Inc.c55efca6-5a5b-134b-e053-2a95a90a82452024-07-31WarningsExact identifier
application number: M006
Gly-Sal 5-2SALICYLIC ACIDTopiderm, Inc.a75e4cee-678f-4e44-9e5e-bafae1c23f9b2024-07-31WarningsExact identifier
application number: M006
Face Reality Advanced Acne MedBENZOYL PEROXIDEFace Realitye1eb8496-0611-4dbc-befb-fb43ec1644332024-07-26WarningsExact identifier
application number: M006
Face Reality 5% Advanced Acne MedBENZOYL PEROXIDEFace Reality0e52972d-b4d9-43f8-8dbb-2eec0782e0f72024-07-26WarningsExact identifier
application number: M006
Face Reality 10% Advanced Acne MedBENZOYL PEROXIDEFace Realitya214ea15-6346-4729-ba84-fbc842faf92a2024-07-26WarningsExact identifier
application number: M006
Replenix Gly-Sal 2-2SALICYLIC ACIDTopiderm, Inc.6c6bbedc-e2ee-46a0-8800-e356bdd262b02024-07-25WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Double Action Acne SerumSALICYLIC ACIDL'Oreal USA Products Incf9daadf9-a9d3-4f2d-af07-5f0b70f7803f2024-07-17WarningsExact identifier
application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.c7164d75-75e7-494a-9595-028ecbf262762024-07-14WarningsExact identifier
application number: M006
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.286f642f-7359-41b9-9daf-e866a87fbefa2024-07-14WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc74c49388-3314-47e8-80b1-19c09e6ea1f92024-07-14WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION873de079-8b8d-45cd-8c7c-4645818f5aaa2024-07-14WarningsExact identifier
application number: M006
Dr. Zenovia Clear ComplexionSALICYLIC ACIDTopiderm, Inc.4ff9b26d-3cd9-4539-b389-edd2df24a4662024-06-28WarningsExact identifier
application number: M006
LEROSETT Botanical Acne CleanserSALICYLIC ACIDGUNILLA OF SWEDEN, INC.8b31d155-c257-4452-9e22-0c69fa36173e2024-06-27WarningsExact identifier
application number: M006
SkinCeuticals Silymarin CF Acne Treatment AntioxidantSALICYLIC ACIDCosmetique Active Productionfcc3c44b-3090-45b5-91e4-e591c92a08c82024-06-24WarningsExact identifier
application number: M006
Peace Out Early Stage Acne DotSALICYLIC ACIDPeace Out LLC.0632d458-d326-ade4-e063-6294a90af3ba2024-06-20WarningsExact identifier
application number: M006
Replenix BP AcneBENZOYL PEROXIDETopiderm, Inc.f449e020-a4d8-4a1b-82eb-4dc59e99b8d42024-06-18WarningsExact identifier
application number: M006
b pure Pressed Powder for Acne Prone Skin FairSALICYLIC ACIDFourstar Group USA, Inc.ecf22bd1-4fc3-4455-ae01-13f97f53dc342024-06-17WarningsExact identifier
application number: M006
b pure Pressed Powder for Acne Prone Skin TanSALICYLIC ACIDFourstar Group USA, Inc.1158f6c2-2b59-4ed3-8d28-73b6da885a5d2024-06-17WarningsExact identifier
application number: M006
Gly-Sal 10-2SALICYLIC ACIDTopiderm, Inc.661cc58b-9360-4b96-b405-afdc2e3783972024-06-13WarningsExact identifier
application number: M006
BLAIR and JACK Anti-Bump Acne TreatmentBENZOYL PEROXIDEBlair + Jackaa8df86a-639c-4416-aadf-4b58566ed9f12024-06-11WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038982salicylic acid 1 % Medicated Liquid SoapPSN39043ea1-6552-717a-e054-00144ff8d46c7
1038982salicylic acid 10 MG/ML Medicated Liquid SoapSCD39043ea1-6552-717a-e054-00144ff8d46c7
1038982salicylic acid 1 % Medicated Liquid SoapSY39043ea1-6552-717a-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-081-0157337008101200 mL in 1 BOTTLE (57337-081-01) 200 ml2016-08-010000-00-00NoNoCurrent