FDA.reportPublic FDA data

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 25 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Curology Acne-Clearing Gel SerumSALICYLIC ACIDCurology, Inc.3e636042-56a9-142b-e063-6394a90a98592025-09-09WarningsExact identifier
application number: M006
Salicylic Acid 2% SolutionSALICYLIC ACIDDeciem39fa19ee-9cc8-8fbc-e063-6394a90a96df2025-09-09WarningsExact identifier
application number: M006
Ology Acne SpotSALICYLIC ACIDWalgreens Co.59a97686-04c0-4d53-9efd-19a1c3ece2d82025-09-05WarningsExact identifier
application number: M006
RoyceDerm Rosacea Treatment Cream.SULPHUR 1X HPUS(10%)RoyceDerm LLC3df717fc-cf2f-8a9a-e063-6394a90ae4e22025-09-04WarningsExact identifier
application number: M006
PHOFAY Salicylic Acid Acne Treatment EssenceSALICYLIC ACIDHangzhou Jingshen Trading Co., Ltd.1a03c857-1040-44ea-817d-7b472160ba6b2025-09-04WarningsExact identifier
application number: M006
BioreSALICYLIC ACIDKao USA Inc.2e1e1aa2-5d41-baa4-e063-6394a90ac3f22025-08-31WarningsExact identifier
application number: M006
Biore Pore Unclogging ScrubSALICYLIC ACIDKao USA Inc.5667307e-0bab-41c3-a2d6-5ca8605468332025-08-28WarningsExact identifier
application number: M006
PHOFAY ACNE SPOTTREATMENT CreamSALICYLIC ACIDHangzhou Jingshen Trading Co., Ltd.3d40c687-7110-46b1-e063-6394a90a84162025-08-26WarningsExact identifier
application number: M006
PHOFAY ACNE SPOT TREATMENT CreamSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd.3d0511f6-168b-5377-e063-6294a90a3ca92025-08-23WarningsExact identifier
application number: M006
PAPATUI Acne Fighting BodySALICYLIC ACIDPAPATUI, LLC3cf9ec1a-4ac3-fceb-e063-6294a90a21a02025-08-22WarningsExact identifier
application number: M006
PAPATUI Acne Fighting Facial CleanserSALICYLIC ACIDPAPATUI, LLC3cfadbb6-fc5e-5696-e063-6394a90a21f42025-08-22WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Stress Control Power Clear ScrubSALICYLIC ACIDKenvue Brands LLC3cc657cd-ad68-505a-e063-6394a90a41b22025-08-20WarningsExact identifier
application number: M006
Neutrogena Body Clear Body Wash Pink GrapefruitSALICYLIC ACIDKenvue Brands LLC3cc7eeb1-972c-25ec-e063-6294a90ae9292025-08-20WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Wash Daily ScrubSALICYLIC ACIDKenvue Brands LLC3ccd4c1b-3784-f767-e063-6294a90a35432025-08-20WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Wash Cream CleanserSALICYLIC ACIDKenvue Brands LLC3c9e91bf-664a-9341-e063-6294a90a7fca2025-08-18WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Stress Control Power-Cream WashSALICYLIC ACIDKenvue Brands LLC3ca05f64-0b97-59b7-e063-6394a90ac5d82025-08-18WarningsExact identifier
application number: M006
Ology Acne Clearing Body MistSALICYLIC ACIDWalgreens Co.33621f58-9df4-a85e-e063-6294a90ae08e2025-08-12WarningsExact identifier
application number: M006
Micro Exfoliating CleanserSALICYLIC ACID SOAPDr. Loretta, LLC7e6855db-a8d5-50ff-e053-2a91aa0a5e172025-08-06WarningsExact identifier
application number: M006
Alumier MD Acne Balancing SerumSALICYLIC ACIDAlumier Labs87eb6adc-c38e-d7df-e053-2a95a90aa7472025-08-06WarningsExact identifier
application number: M006
my beauty spot BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.cf36f10f-015d-491e-b8b9-99e130f67deb2025-08-01WarningsExact 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