FDA.reportPublic FDA data

SUPER SPOT REMOVER ACNE TREATMENT

Product NDC
59427-005
11-digit product format
594270005
Labeler code
59427
Product ID
59427-005_46011cef-0255-9f06-e063-6394a90ad2f4
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
ORIGINS NATURAL RESOURCES INC.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-01
Substance
SALICYLIC ACID
Active strength
15 mg/mL
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59427-005-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59427-005-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59427-005-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
SUPER SPOT REMOVER ACNE TREATMENT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID15 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416212Internal RxNorm lookup
2468334Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0aece76-008b-4af3-be39-13156acc73afAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59427-005-012020-12-10C16284748780-19d75b9d0-5b60-f424-e053-dadaa90a57ceSUPER SPOT REMOVER™ ACNE TREATMENT
59427-005-012020-01-31C16284748780-19d75b9d0-5b60-f424-e053-dadaa90a57ceSUPER SPOT REMOVER™ ACNE TREATMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59427-005-01SUPER SPOT REMOVER ACNE TREATMENT1 in 1 CARTONGEL115
59427-005-01SUPER SPOT REMOVER ACNE TREATMENT10 mL in 1 CONTAINERGEL1015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZSUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0SUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
appleINACTIVE INGREDIENTB423VGH5S9SUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
butylene glycolINACTIVE INGREDIENT3XUS85K0RASUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
caffeineINACTIVE INGREDIENT3G6A5W338ESUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
clove oilINACTIVE INGREDIENT578389D6D0SUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
cucumberINACTIVE INGREDIENTYY7C30VXJTSUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
eugenolINACTIVE INGREDIENT3T8H1794QWSUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXSUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
magnesium ascorbyl phosphateINACTIVE INGREDIENT0R822556M5SUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TSUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
saccharina latissimaINACTIVE INGREDIENT68CMP2MB55SUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
scutellaria baicalensis rootINACTIVE INGREDIENT7J95K7ID2SSUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ISUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
waterINACTIVE INGREDIENT059QF0KO0RSUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1
witch hazelINACTIVE INGREDIENT101I4J0U34SUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59427-005SUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]14Current NDC, Legacy NDC, 2 package rows20240927_a0aece76-008b-4af3-be39-13156acc73af.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
416212salicylic acid 1.5 % Topical GelPSNa0aece76-008b-4af3-be39-13156acc73af15
2468334Super Spot Remover 1.5 % Topical GelPSNa0aece76-008b-4af3-be39-13156acc73af15
2468334salicylic acid 0.015 MG/MG Topical Gel [Super Spot Remover]SBDa0aece76-008b-4af3-be39-13156acc73af15
416212salicylic acid 0.015 MG/MG Topical GelSCDa0aece76-008b-4af3-be39-13156acc73af15
416212salicylic acid 1.5 % Topical GelSYa0aece76-008b-4af3-be39-13156acc73af15
2468334Super Spot Remover 0.015 MG/MG Topical GelSYa0aece76-008b-4af3-be39-13156acc73af15
2468334Super Spot Remover 1.5 % Topical GelSYa0aece76-008b-4af3-be39-13156acc73af15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59427-005-01594270005011 CONTAINER in 1 CARTON (59427-005-01) / 10 mL in 1 CONTAINER1 container2020-11-240000-00-00NoNoCurrent