FDA.reportPublic FDA data

EradiKate ACNE TREATMENT

Product NDC
43479-106
11-digit product format
434790106
Labeler code
43479
Product ID
43479-106_2b826d62-b44e-974d-e063-6394a90a109d
Type
HUMAN OTC DRUG
Nonproprietary name
SULFUR
Dosage form
LIQUID
Route
TOPICAL
Labeler
Kate Somerville Skincare, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-15
Substance
SULFUR
Active strength
10 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43479-106-510efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43479-106-51ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43479-106-51367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43479-106-51557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43479-106-518af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43479-106-51834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43479-106-511332a3947898…d4bfe170f9cd…

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
EradiKate ACNE TREATMENT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198869Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
713093d9-29c3-44c9-b90f-ee7448c5063eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43479-106-512025-01-12C16284748780-11030e365-1aad-111a-e063-dadaa90a10e2Kate Somerville (as PLD) - EradiKate Acne Treatment (43479-106)
43479-106-512024-01-30C16284748780-11030e365-1aad-111a-e063-dadaa90a10e2Kate Somerville (as PLD) - EradiKate Acne Treatment (43479-106)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43479-106-11EradiKate ACNE TREATMENT30 mL in 1 BOTTLE, GLASSLIQUID308
43479-106-51EradiKate ACNE TREATMENT1 in 1 BOXLIQUID18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU70ERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
SULFURACTIVE MOIETY70FD1KFU70ERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941ERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5HERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43479-106ERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]8Current NDC, Legacy NDC, 2 package rows20250113_713093d9-29c3-44c9-b90f-ee7448c5063e.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 12 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne TreatmentBENZOYL PEROXIDETopco Associates LLC8d5e7e40-5e61-470a-b8ff-0b2dca3cabb02026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDETopco Associates LLC8474d917-7ee4-4d1d-8499-3520f771d2fd2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Body WashSALICYLIC ACIDTopco Associates LLC1b16b978-70e0-4bba-a8d7-a77d7e1f896a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDTopco Associates LLCe98a8184-c5a8-4306-9fff-9dc77e9d2d442026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic AcidASTRINGENTTopco Associates LLC7d15560f-d8d1-4dfe-8eca-b16bb529ad872026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Topco Associates LLC3149260c-b92b-43a7-8f57-897517102fa82026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEWalgreen Co.07721aa6-867a-436f-8c88-ab135f02a6b52026-02-12Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDAmazon.com Services LLC06339296-14e7-4179-aa2f-538bae921a8b2026-02-11Warnings, Adverse reactionsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC3af85c98-f14d-5857-e063-6394a90aed132026-02-10WarningsExact identifier
application number: M006
ACNE TREATMENTTREATBio Clarity LLC4a7e40c1-7421-a0c7-e063-6294a90a4d6b2026-02-10WarningsExact identifier
application number: M006
HerbaGlow Baiwooxia Anti-Acne GelSALICYLIC ACID GELKungpo Health Care & Herbal Center Inc010029a3-8c1a-4f29-a162-a8ba4f9390582026-02-10WarningsExact identifier
application number: M006
Acne CleanserBENZOYL PEROXIDEWalmart, Inc.04514cbb-6041-4bd5-9ab9-31312b0d8f192026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic acidSALICYLIC ACIDTopco Associates LLC4a28800d-14ef-d841-e063-6394a90a692b2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDRetail Business Services, LLC1942bd34-a152-450e-a5c5-46488da66b3d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%American Sales Company613f0a91-32d3-4a1e-9c9f-f0167481b5112026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
ACNE DOTS (Skin Care Multi-Pack)SALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.4a0dc951-07ce-2030-e063-6294a90ab2ea2026-02-05WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Publix Super Markets, Inc.169eaaa4-308d-44ba-ad93-3205e0dd9ae12026-02-05Warnings, Adverse reactionsExact identifier
application number: M006
SPOTLESS Daily Acne WashBENZOYL PEROXIDERodan & Fields8f7bb793-3c60-4014-954e-514ef87a44fb2026-02-04WarningsExact identifier
application number: M006
SPOTLESS Acne Clearing TreatmentBENZOYL PEROXIDERodan & Fields3d4ef4ce-9be3-436a-9f93-c01caa93d1a82026-02-04WarningsExact identifier
application number: M006
SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTSBENZOYL PEROXIDERodan & Fields8b2c187d-4b66-4872-8243-4365ea2e8b592026-02-04WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198869sulfur 10 % Topical SolutionPSN713093d9-29c3-44c9-b90f-ee7448c5063e8
198869sulfur 100 MG/ML Topical SolutionSCD713093d9-29c3-44c9-b90f-ee7448c5063e8
198869sulfur 10 % Topical SolutionSY713093d9-29c3-44c9-b90f-ee7448c5063e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43479-106-114347901061130 mL in 1 BOTTLE, GLASS30 mlHistorical
43479-106-51434790106511 BOTTLE, GLASS in 1 BOX (43479-106-51) / 30 mL in 1 BOTTLE, GLASS (43479-106-11) 2014-06-150000-00-00NoNoCurrent