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#

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 21 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne CleanserSALICYLIC ACIDCurology44730f63-1f22-27a5-e063-6294a90a63c22025-11-25WarningsExact identifier
application number: M006
Ayadara Cystic Acne Spot TreatmentSULFURLeiluna LLC3cc17e7a-34d4-4789-a387-40e4d781091b2025-11-25WarningsExact identifier
application number: M006
Shaant Pore Purifying Face ScrubSALICYLIC ACIDCodex Labs Corporationd806e749-ea2c-4db4-af65-a1f8afce1b0e2025-11-21WarningsExact identifier
application number: M006
Shaant Spot Hero Drying Acne TreatmentSULFURCodex Labs Corporation24fa844b-e4ce-46de-a2d6-e9e863888a552025-11-21WarningsExact identifier
application number: M006
Shaant Hydrating Body ScrubSALICYLIC ACIDCodex Labs Corporation64a176a1-7dc4-44f8-8b3d-4349460a17b02025-11-21WarningsExact identifier
application number: M006
CAVOREAL Plus Salicylic Acid Anti Acne with BHA HASALICYLIC ACIDGuangzhou Meijiao Medical Biotechnology Co., Ltd.4401fff2-725f-8ff0-e063-6294a90ae9ba2025-11-20WarningsExact identifier
application number: M006
CAVOREAL Plus Salicylic Acid Anti Acne with BHA HASALICYLIC ACIDGuangzhou Meijiao Medical Biotechnology Co., Ltd.440a3a73-7136-f8b2-e063-6394a90a744d2025-11-20WarningsExact identifier
application number: M006
Acne Defense Spot Treatment Merle NormanSALICYLIC ACIDMerle Norman Cosmetics, Incc6296d3a-fabe-4a8f-91e8-cac2ae6ff9262025-11-18WarningsExact identifier
application number: M006
Perricone MD Acne Relief Calming and Soothing Clay MaskSALICYLIC ACIDTHG Beauty USA LLC23a3d093-e89b-ddaf-e063-6394a90aaa6a2025-11-14WarningsExact identifier
application number: M006
Daily MedsSALICYLIC ACIDBioelements, Inc.3ffb6cd0-c529-4420-8da8-de52838d8a642025-11-14WarningsExact identifier
application number: M006
Naturium Encapsulated Salicylic Acid Moisturizer 0.75%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a4a0de1-6feb-bf9a-e063-6394a90a32d92025-11-14WarningsExact identifier
application number: M006
Naturium Salicylic Acid Body 2%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a5b80fb-caec-eb56-e063-6294a90a238b2025-11-14WarningsExact identifier
application number: M006
Naturium Salicylic Acid Serum 2%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a28640e-37f8-9a74-e063-6294a90a15b72025-11-14WarningsExact identifier
application number: M006
Naturium Sulfur Spot Treatment 8%SULFURe.l.f. Cosmetics, Inc0a4a9aed-5eeb-f648-e063-6394a90a1d762025-11-14WarningsExact identifier
application number: M006
Acne Spot TreatmentSALICYLIC ACID ACNE TREATMENTCosMedical Technologies23bd8842-5237-4131-e054-00144ff8d46c2025-11-13WarningsExact identifier
application number: M006
Overnight Spot TreatmentACNE TREATMENTCosMedical Technologies23bde802-d84a-1ecc-e054-00144ff88e882025-11-13WarningsExact identifier
application number: M006
Personox Ultimate Scrub CleanserSALICYLIC ACIDStonebridge Consultants LLC2b8b5134-ad05-3345-e063-6294a90a87512025-11-12WarningsExact identifier
application number: M006
Clinicians ComplexSULFURCosmed Dermaceuticals, Inc.256e3e4e-2219-45f8-ab78-a6a541767de82025-11-11WarningsExact identifier
application number: M006
CLEARSYNERGYSALICYLIC ACIDSRL ENTERPRISES LLCdf0a4398-4c21-421a-a7dd-92149b1dc8a62025-11-11WarningsExact identifier
application number: M006
Clinicians ComplexSULFURSkinSx.com, Inc.0f13770a-774b-49ad-8417-02928371682a2025-11-11WarningsExact 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