FDA.reportPublic FDA data

Drs. ACNE SPOT TREATMENT

Product NDC
80489-357
Requested package NDC
80489-357-01
11-digit product format
804890357
Labeler code
80489
Product ID
80489-357_56368d1e-55eb-bf6c-e063-6294a90a4a90
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
OL PHARMA TECH, LLC Drs. PHARMACY
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-01
Substance
SALICYLIC ACID
Active strength
20 mg/g
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
Drs. ACNE SPOT TREATMENT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID20 mg/g

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
161b2306-364a-e1b8-e063-6394a90a6c88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
80489-357-01161b2306-364a-e1b8-e063-6394a90a6c88
80489-357-01161b2306-364a-e1b8-e063-6394a90a6c88
80489-357-02161b2306-364a-e1b8-e063-6394a90a6c88
80489-357-02161b2306-364a-e1b8-e063-6394a90a6c88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-357-01Drs. ACNE SPOT TREATMENT1 in 1 CARTONGEL12
80489-357-01Drs. ACNE SPOT TREATMENT20 g in 1 TUBE, WITH APPLICATORGEL202
80489-357-02Drs. ACNE SPOT TREATMENT1 in 1 CARTONGEL12
80489-357-02Drs. ACNE SPOT TREATMENT30 g in 1 TUBE, WITH APPLICATORGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-357DRS. ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [OL PHARMA TECH, LLC DRS. PHARMACY]2Current NDC, 4 package rows20240417_161b2306-364a-e1b8-e063-6394a90a6c88.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 4 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4c3bfa-32ec-c0dd-e063-6394a90ab15c2026-07-21WarningsExact identifier
application number: M006
OURUI ONE FACIAL BUMP REFINING ESSENCESALICYLIC ACID 0.25% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4959bb67-063f-ffa4-e063-6394a90aa01f2026-07-20WarningsExact identifier
application number: M006
Beilloso FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4a461a7a-f5cf-6544-e063-6294a90a00f22026-07-20WarningsExact identifier
application number: M006
Lepnuns MILIA REMOVERDIDECYL DIMETHYL AMMONIUM CHLORIDE 0.025% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD497ed53c-2562-b370-e063-6294a90a5ba12026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Molecules, LLC44fa9eda-0910-7d70-e063-6394a90af3a72026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Moleculesdec189a2-5f93-7c3e-e053-2a95a90af9882026-07-20WarningsExact identifier
application number: M006
Clean and Clear Essentials Acne TonerSALICYLIC ACIDKenvue Brands LLC06cd03e3-6146-65d8-e063-6294a90a17012026-07-17WarningsExact identifier
application number: M006
24 Hour Acne SerumBENZOYL PEROXIDEDrmtlgy, LLC55507941-dbdf-4e5f-a74d-4da6f67b6a1f2026-07-17WarningsExact identifier
application number: M006
PCA Skin Acne Control Prebiotic CleanserSALICYLIC ACIDCP Skin Health Group, Inc.56bca675-3e59-815a-e063-6294a90a1d872026-07-16WarningsExact identifier
application number: M006
Acne patchesACNE PATCHESShenzhen Hengdasheng Technology Co., Ltd5664b9c4-6ae3-4f64-e063-6294a90a825a2026-07-14WarningsExact identifier
application number: M006
Zmztuhua Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.567ceafc-b75a-9777-e063-6394a90ae1602026-07-13WarningsExact identifier
application number: M006
Magnilife Eczema CareSULFUR, GRAPHITE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS WHOLEThe Magni Group, Inc.8e3fc743-4c82-4a03-a963-2d5f93a1bc262026-07-13WarningsExact identifier
application number: M006
PHYLA ACNE PHAGE SERUMSALICYLIC ACIDCOSMAX USA, CORP564abe82-c983-6a98-e063-6394a90a14a02026-07-10WarningsExact identifier
application number: M006
GOOD MOLECULE MAXIMUM STRENGHT ACNESALICYLIC ACIDCOSMAX USA, CORP564aafc0-1a06-1cba-e063-6294a90ae7382026-07-10WarningsExact identifier
application number: M006
Touch Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEDiractions Capital LLC1ae4e081-b04a-407d-992d-cd398f3afc542026-07-10WarningsExact identifier
application number: M006
Drs. ACNE SPOT TREATMENTSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACY161b2306-364a-e1b8-e063-6394a90a6c882026-07-09WarningsExact identifier
application number: M006
ndc (package): 80489-357-01
ndc (product): 80489-357
ndc11 (package): 80489035701
Proactiv Acne Body WashSALICYLIC ACIDAlchemee, LLC36aef223-6a4a-433f-b292-631e6068b17f2026-07-08WarningsExact identifier
application number: M006
LadovernaBENZOYL PEROXIDE CREAMGuangzhou Oupeng Cosmetics Co., Ltd.55b0f9fd-9055-6969-e063-6294a90a1a7d2026-07-07WarningsExact identifier
application number: M006
L BRI KlearawaySALICYLIC ACIDL'BRI Health & Beautyb9aa1c48-b767-47b0-bb98-efb7e860ab362026-07-06WarningsExact identifier
application number: M006
L BRI Deep Clean TonerSALICYLIC ACIDL'BRI Health & Beauty607fb6d0-ae49-472c-9224-0673af934bd22026-07-06WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSN161b2306-364a-e1b8-e063-6394a90a6c882
346298salicylic acid 0.02 MG/MG Topical GelSCD161b2306-364a-e1b8-e063-6394a90a6c882
346298salicylic acid 2 % Topical GelSY161b2306-364a-e1b8-e063-6394a90a6c882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80489-357-01804890357011 TUBE, WITH APPLICATOR in 1 CARTON (80489-357-01) / 20 g in 1 TUBE, WITH APPLICATOR2024-04-13NoNoCurrent