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 39 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rush Salicylc Acid Complexion PadsSALICYLIC ACIDG.S. COSMECEUTICAL USA, INC.e9c3c3aa-e0e0-45aa-b97c-dc211e2f62b12024-11-26WarningsExact identifier
application number: M006
EVEN BETTER CLINICAL ACNE SOLUTIONSSALICYLIC ACIDCLINIQUE LABORATORIES LLC02e22431-ae2f-1f42-e063-6394a90aa3af2024-11-25WarningsExact identifier
application number: M006
Oxy Hydrating Anti-Blemish Body WashOXY HYDRATING ANTI-BLEMISH BODY WASHThe Mentholatum Company21b64a3f-2c90-1c1a-e063-6294a90a0ea02024-11-23WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Stress Control Power-Cream WashSALICYLIC ACIDKenvue Brands LLCf1d1053e-d863-4f02-9339-843d3d3e630e2024-11-20WarningsExact identifier
application number: M006
Equate Acne Wash Acne medicationBENZOYL PEROXIDEWal-Mart Stores, Inc.3c108488-dfaf-447c-ba26-15fd7cf677612024-11-18WarningsExact identifier
application number: M006
ACNE solutions CLARIFYINGSALICYLIC ACIDCLINIQUE LABORATORIES LLCdc1b2e2e-0e13-4029-bdac-44adb70492fd2024-11-18WarningsExact identifier
application number: M006
Meijer Maximum Strength Foaming Acne Face Wash Acne MedicationBENZOYL PEROXIDEMeijer Distribution, Inc4cfbaa79-ee6c-4946-8f8c-cda71b7a80fd2024-11-15WarningsExact identifier
application number: M006
amazon basics acne blackhead clearing scrub Acne TreatmentSALICYLIC ACIDAMAZON.COM SERVICES LLC8e129137-85c6-423d-936e-4266988506a22024-11-15WarningsExact identifier
application number: M006
AGE INTERVENTION DUALITY MDBENZOYL PEROXIDEG.S. COSMECEUTICAL USA, INC.6d885fe2-8a2d-44d4-84d9-932c48260f792024-11-15WarningsExact identifier
application number: M006
AGE INTERVENTION DUALITYBENZOYL PEROXIDEG.S. COSMECEUTICAL USA, INC.33fb5893-ea63-49a3-bb02-6b98c747c4fe2024-11-15WarningsExact identifier
application number: M006
Amazon Basics Acne Wash Acne treatmentSALICYLIC ACIDAMAZON.COM SERVICES LLC2e41ca5f-127a-4387-a64a-c5a4ab36192a2024-11-15WarningsExact identifier
application number: M006
Meijer Acne Foaming Cleanser Acne TreatmentBENZOYL PEROXIDEMeijer Distribution, Inccbf0587a-29c4-47ce-bd09-2bccaddba3b72024-11-15WarningsExact identifier
application number: M006
e.l.f Plz Clarify Facial OilE.L.F PLZ CLARIFY FACIAL OILZhejiang Ayan Biotech Co., Ltd.25a8a0fe-d09b-3e20-e063-6394a90a51f02024-11-14WarningsExact identifier
application number: M006
amazon basics acne foaming cleanser Acne TreatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLCbdfbaeab-137a-49d5-bdc3-06349b8a05642024-11-14WarningsExact identifier
application number: M006
amazon basics advanced blemish spot treatment Acne medicationSALICYLIC ACIDAMAZON.COM SERVICES LLC67c1ef50-ecae-46a5-924e-1cff194810502024-11-14WarningsExact identifier
application number: M006
Neutrogena SkinClearing Mineral Powder Chestnut 135SALICYLIC ACIDKenvue Brands LLC0d1556d3-d689-c4c1-e063-6394a90adab02024-11-13WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne WashSALICYLIC ACIDKenvue Brands LLC581ea73f-439a-4290-a8c0-98a25b4496dc2024-11-12WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial CleanserSALICYLIC ACIDKenvue Brands LLC2dde181f-d24f-4239-bec5-ded7fdbc98c42024-11-12WarningsExact identifier
application number: M006
Neutrogena deep clean purifying cooling gel scrubSALICYLIC ACIDKenvue Brands LLCda2ce634-36c4-b5b7-e053-2a95a90abefb2024-11-12WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Mattifying Acne MoisturizerSALICYLIC ACIDGalderma Laboratories, L.P.72977030-d9b6-435f-b321-edcbbb7315872024-11-12WarningsExact 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