FDA.reportPublic FDA data

GOODBYE ACNE THERAPEUTIC SULFUR MASK

Product NDC
54031-107
11-digit product format
540310107
Labeler code
54031
Product ID
54031-107_308ec305-dbf4-c6f9-e063-6294a90a14ec
Type
HUMAN OTC DRUG
Nonproprietary name
SULFUR
Dosage form
PASTE
Route
TOPICAL
Labeler
PETER THOMAS ROTH, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
SULFUR
Active strength
14.458 g/144.58g
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
GOODBYE ACNE THERAPEUTIC SULFUR MASK
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR14.458 g/144.58g

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
2708845Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
308ec305-dbf3-c6f9-e063-6294a90a14ecAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54031-107-02GOODBYE ACNE THERAPEUTIC SULFUR MASK144.58 g in 1 CARTONPASTE144.581
54031-107-14GOODBYE ACNE THERAPEUTIC SULFUR MASK144.58 g in 1 JARPASTE144.581
54031-107-16GOODBYE ACNE THERAPEUTIC SULFUR MASK48.19 g in 1 JARPASTE48.191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54031-107GOODBYE ACNE THERAPEUTIC SULFUR MASK (SULFUR) PASTE [PETER THOMAS ROTH, LLC]1Current NDC, 3 package rows20250321_308ec305-dbf3-c6f9-e063-6294a90a14ec.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 54 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Studio Done With Zit Acne Treatment Clearing GelSALICYLIC ACIDAccess Business Group LLC7a9bb4a0-c463-44e8-90a3-12bd58829f9d2023-10-21WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDChina Ningbo Shangge Cosmetics Technology Corp.074079cd-866d-0af0-e063-6394a90a72142023-10-09WarningsExact identifier
application number: M006
Skin Laundry. Clean Slate Exfoliating 2 Salicylic Acid Treatment Gel Cleanser Cleanse ExfoliateSALICYLIC ACIDSkin Laundry Holdings, Inc.07100fe5-3884-0948-e063-6294a90a6ec72023-10-06WarningsExact identifier
application number: M006
NAS PORE REFINING SCRUBSALICYLIC ACIDBURT'S BEES, INC.bc2c6b1e-999c-91a7-e053-2a95a90a9d1a2023-10-05WarningsExact identifier
application number: M006
NAS Targeted Spot TreatmentSALICYLIC ACIDBurt's Beesbc193e1f-c2bd-6415-e053-2995a90ae6eb2023-10-05WarningsExact identifier
application number: M006
ACNE AND LINE CORRECTING SERUMSALICYLIC ACIDCLINIQUE LABORATORIES LLCb03bdef4-a099-4543-8673-85466bd649612023-10-05WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDERejoice International Corp.06de40a2-45bf-bf4b-e063-6294a90a586c2023-10-04WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDRejoice International Corp.06df07f7-e4c5-ccef-e063-6394a90a9f3c2023-10-04WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDEChina Ningbo Shangge Cosmetics Technology Corp.06e07266-6483-e7ef-e063-6294a90a93952023-10-04WarningsExact identifier
application number: M006
Acne ControlCREAMWalgreenfc60cccb-405b-e49e-e053-6394a90a5a122023-09-11WarningsExact identifier
application number: M006
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
application number: M006
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
application number: M006
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
application number: M006
ACNE CLEANSINGSALICYLIC ACIDCLINIQUE LABORATORIES LLC7bae5802-cf51-4b41-9d7c-d72f1eb4c4af2023-08-30WarningsExact identifier
application number: M006
Gly-Sal 2-2 PadsSALICYLIC ACIDTopiderm, Inc.a92a9ffb-5c5b-43a4-b669-04667324920b2023-02-16WarningsExact identifier
application number: M006
Derma E Acne Clarifying MaskSULFURderma e55df8fb4-abc3-43fe-b89b-6e7d638b27a62023-02-14WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2708845sulfur 10 % PastePSN308ec305-dbf3-c6f9-e063-6294a90a14ec1
2708845sulfur 0.1 MG/MG PasteSCD308ec305-dbf3-c6f9-e063-6294a90a14ec1
2708845sulfur 10 % PasteSY308ec305-dbf3-c6f9-e063-6294a90a14ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54031-107-0254031010702144.58 g in 1 CARTON (54031-107-02) 144.58 g2024-08-01NoNoCurrent
54031-107-1454031010714144.58 g in 1 JAR (54031-107-14) 144.58 g2024-08-01NoNoCurrent
54031-107-165403101071648.19 g in 1 JAR (54031-107-16) 48.19 g2024-02-01NoNoCurrent