FDA.reportPublic FDA data

SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENT

Product NDC
58411-615
11-digit product format
584110615
Labeler code
58411
Product ID
58411-615_47ac27e9-02d8-dfb3-e063-6294a90ad76d
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
SALICYLIC ACID
Active strength
.1 g/20mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID.1 g/20mL

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
252296Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b584705-21a8-4e37-96cc-f9c8058db5c4Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-615-60SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENT1 in 1 CARTONGEL13
58411-615-60SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENT20 mL in 1 TUBEGEL203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-615SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENT (SALICYLIC ACID) GEL [SHISEIDO AMERICAS CORPORATION]2Current NDC, Legacy NDC, 2 package rows20240113_3b584705-21a8-4e37-96cc-f9c8058db5c4.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 3 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Free Free 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939847a-72eb-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006
Terminator 10BENZOYL PEROXIDEAcneFree, LLCc06778b6-0ed6-7d82-e053-2a95a90a2ef82026-07-31WarningsExact identifier
application number: M006
Acne Free Oil Free Acne Cleanser 2.5 Benzoyl PeroxideBENZOYL PEROXIDEAcneFree LLCc939847a-72cc-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006
Benzoyl Peroxide Deep Cleansing Foaming WashBENZOYL PEROXIDEAcneFree, LLCfe2d0e24-8c68-b2ea-e053-6294a90ad72c2026-07-31WarningsExact identifier
application number: M006
Salicylic AcidSALICYLIC ACIDAcne Free, LLC1097fc73-fa47-0f14-e063-6294a90aa4992026-07-31WarningsExact identifier
application number: M006
Even and Clear CleanserSALICYLIC ACIDAmbi Enterprises LLCbff537cf-aa79-5250-e053-2995a90a388a2026-07-31WarningsExact identifier
application number: M006
Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne CleanserBENZOYL PEROXIDEAcneFree, LLCc7a675fa-b6c0-6237-e053-2a95a90a04062026-07-31WarningsExact identifier
application number: M006
Acne Free SEVERE ACNE 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939681e-ea93-31ce-e053-2a95a90a8c702026-07-31WarningsExact identifier
application number: M006
Acne Free SENSITIVE SKIN 24 HR Acne Clearing SystemSALICYLIC ACID, BENZOYL PEROXIDEAcneFree LLCc9397a25-8fed-48d0-e053-2a95a90ab4952026-07-31WarningsExact identifier
application number: M006
sulfur acne treatmentSULFURAcne Free105545d8-974c-5a9a-e063-6294a90aecc42026-07-31WarningsExact identifier
application number: M006
24 Hour Sensitive Skin Acne Clearing SystemSALICYLIC ACIDAcne Free LLC39ea674d-ff6e-a8c6-e063-6394a90a06562026-07-31WarningsExact identifier
application number: M006
cardae FOLLICULITIS CreamMICONAZOLE NITRATE 2% FOLLICULITIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57e0be6a-3141-f3b6-e063-6394a90a15202026-07-30WarningsExact identifier
application number: M006
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENTSALICYLIC ACIDGold Inti Trade Corporation57a7c929-31f5-ef82-e063-6394a90ab9af2026-07-28WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.4a1591e8-6135-4b22-b54c-5553c2dc05402026-07-28WarningsExact identifier
application number: M006
amberglow BLEMISH PATCHESSALICYLIC ACIDPearl World Inc.12054430-25ff-4b72-8f64-822b27abb4432026-07-27WarningsExact identifier
application number: M006
RFA BPO Acne Treatment 2.5%BENZOYL PEROXIDETopiderm, Inc.c5053e9e-7608-45d9-9b9b-9b93210eb9172026-07-27WarningsExact identifier
application number: M006
ACNO Solution ACNE TREATMENTSALICYLIC ACIDNoon Aesthetics M.R. Ltd4a267e44-03d9-471f-9708-a5c60ff690972026-07-24WarningsExact identifier
application number: M006
DERMFREE MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c8a6e-b02d-3a87-e063-6294a90a14ff2026-07-23WarningsExact identifier
application number: M006
salicylic acidSALICYLIC ACIDChain Drug Marketing Association4dc96074-50a1-baa8-e063-6294a90a5aab2026-07-22Warnings, Adverse reactionsExact identifier
application number: M006
SYLVIRENE MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a3751f8-2365-1b34-e063-6394a90acf742026-07-21WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252296salicylic acid 0.5 % Topical GelPSN3b584705-21a8-4e37-96cc-f9c8058db5c43
252296salicylic acid 0.005 MG/MG Topical GelSCD3b584705-21a8-4e37-96cc-f9c8058db5c43
252296salicylic acid 0.5 % Topical GelSY3b584705-21a8-4e37-96cc-f9c8058db5c43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-615-60584110615601 TUBE in 1 CARTON (58411-615-60) / 20 mL in 1 TUBE1 tube2021-01-010000-00-00NoNoCurrent