FDA.reportPublic FDA data

TOME Clearing Treatment

Product NDC
87609-104
Requested package NDC
87609-104-01
11-digit product format
876090104
Labeler code
87609
Product ID
87609-104_5bcb4312-6647-32ca-e063-6294a90aa7f7
Type
HUMAN OTC DRUG
Nonproprietary name
0.5% Salicylic Acid Wipe with Bioneedle Mask
Dosage form
KIT
Route
TOPICAL
Labeler
Dermata Therapeutics, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-10
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
TOME Clearing Treatment
Listing expiration
2027-12-31

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 38 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear System Clarifying Gel CleanserSALICYLIC ACIDBentley Laboratories, LLC08248e40-aa71-4dfb-8a75-af8886ccb9762024-12-04WarningsExact identifier
application number: M006
DermaClear BHA CleanserSALICYLIC ACIDAllure Labs Incbfeced33-a630-4f1d-9ecf-33450bd26ae92024-12-03WarningsExact identifier
application number: M006
PCA SKIN Intensive Clarity TreatmentSALICYLIC ACIDCP Skin Health Group, Inc.7bd6edc0-941e-492d-8b3c-4e8b3425f9292024-12-03WarningsExact identifier
application number: M006
PCA SKIN BPO CleanserBENZOYL PEROXIDECP Skin Health Group, Inc.eb55cc26-cf47-4e9e-b7a8-23ef82aecce22024-12-03WarningsExact identifier
application number: M006
PCA SKIN AcneBENZOYL PEROZIDECP Skin Health Group, Inc.257bd9dd-93f9-4996-8478-8198be3ef6832024-12-03WarningsExact identifier
application number: M006
PCA GelSALICYLIC ACIDCP Skin Health Group, Inc396b4675-451f-48b2-b139-19508434e0fe2024-12-03WarningsExact identifier
application number: M006
CliniCalmHYDROCORTISONECP Skin Health Group, Inc.febcf7e8-668c-a5c9-e053-6394a90aec392024-12-03WarningsExact identifier
application number: M006
Alumier MD Acne Clarifying CleanserSALICYLIC ACIDAlumier Labs87747f82-9018-ab34-e053-2995a90a68082024-12-01WarningsExact identifier
application number: M006
Acne Control Face WashSALICYLIC ACIDBentley Laboratories, LLC068c5fef-cdc5-49f4-9372-9cfdd07508b82024-11-28WarningsExact identifier
application number: M006
Acne Control Body WashSALICYLIC ACIDBentley Laboratories, LLC3db0f885-4c08-4678-8533-ba2025bf7d482024-11-28WarningsExact identifier
application number: M006
Neutrogena Stubborn Blackheads Daily SerumSALICYLIC ACIDKenvue Brands LLCc0992ceb-5f7a-4c8f-a43f-7a300bd6bbf12024-11-26WarningsExact identifier
application number: M006
Neutrogena Stubborn Acne Spot DryingSULFURKenvue Brands LLCdffe9bf4-a8a2-4fa0-e053-2995a90abcb32024-11-26WarningsExact identifier
application number: M006
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87609-104-01876090104014 BOX in 1 BOX (87609-104-01) / 1 PACKET in 1 BOX / 1 KIT in 1 PACKET * 3 mL in 1 TUBE * 3.66 g in 1 PACKET * 1 g in 1 CUP4 box2026-09-10NoNoCurrent