FDA.reportPublic FDA data

GOODBYE ACNE Complete treatment gel

Product NDC
54031-069
Requested package NDC
54031-069-01
11-digit product format
540310069
Labeler code
54031
Product ID
54031-069_0a20cdf1-4008-331f-e063-6394a90a04dc
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Peter Thomas Roth, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-15
Substance
SALICYLIC ACID
Active strength
.9638 g/48.19g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GOODBYE ACNE Complete treatment gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID.9638 g/48.19g

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
346298Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
09b88031-f5fe-8ae1-e063-6394a90a8a6aAvailable 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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54031-069-01GOODBYE ACNE Complete treatment gel48.19 g in 1 TUBEGEL48.192
54031-069-02GOODBYE ACNE Complete treatment gel48.19 g in 1 CARTONGEL48.192

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54031-069GOODBYE ACNE COMPLETE TREATMENT GEL (SALICYLIC ACID) GEL [PETER THOMAS ROTH, LLC]2Current NDC, 2 package rows20231115_09b88031-f5fe-8ae1-e063-6394a90a8a6a.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 1 of 55 · 1,083 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PIMPLE PATCHESPIMPLE PATCHESShenzhen Hengdasheng Technology Co., Ltd584d3833-4593-94db-e063-6294a90ad3ff2026-08-05WarningsExact identifier
application number: M006
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
application number: M006
Sulfur Acne Foaming CleanserSULFURAcne Free, LLCfeb82a3d-cda3-c62a-e053-6394a90ad9bb2026-07-31WarningsExact identifier
application number: M006
Acne Free BLACKHEAD REMOVING SCRUB 2 Salicylic Acid with CharcoalSALICYLIC ACIDAcneFree LLCc9393340-8a5f-6b7c-e053-2995a90afcd92026-07-31WarningsExact identifier
application number: M006
AMBI Even and Clear Exfoliating Wash Acne TreatmentSALICYLIC ACIDAMBI ENTERPRISES, LLC43a4712d-9a6d-4bfc-abe4-f6e81dca35492026-07-31WarningsExact identifier
application number: M006
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
BellamiLuxx Butt Acne Treatment CreamSALICYLIC ACID 2%BellamiLuxx LLC42f3367f-40a2-5d97-e063-6294a90a6e332026-07-28WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.4a1591e8-6135-4b22-b54c-5553c2dc05402026-07-28WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSN09b88031-f5fe-8ae1-e063-6394a90a8a6a2
346298salicylic acid 0.02 MG/MG Topical GelSCD09b88031-f5fe-8ae1-e063-6394a90a8a6a2
346298salicylic acid 2 % Topical GelSY09b88031-f5fe-8ae1-e063-6394a90a8a6a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54031-069-015403100690148.19 g in 1 TUBE (54031-069-01) 48.19 g2021-06-15NoNoCurrent