Cleanser

Product NDC
61354-068
11-digit product format
613540068
Labeler code
61354
Product ID
61354-068_e5e5624d-3a68-0f30-e053-2a95a90a7609
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Oxygen Development LLC
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-08-25
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 mg/100mg
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61354-068DDiscontinued by firm2026-10-15
excluded packagepackage61354-06861354-068-01DDiscontinued by firm2026-10-15

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61354-068-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61354-068-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61354-068-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61354-068-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61354-068-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61354-068-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61354-068-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61354-068-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61354-068-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61354-068-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61354-068-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61354-068-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 50 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vichy Laboratoires Normaderm SOS Acne Rescue Spot CorrectorSULFURL'Oreal USA Products Inc4907bc52-62e3-4256-b4ca-bcde896a4aab2023-12-27WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula PadsSALICYLIC ACIDL'Oreal USA Products Incbc0d1691-c13d-4c15-8c44-ecee30cb0ae22023-12-27WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula CleanserSALICYLIC ACIDL'Oreal USA Products Inc935a58f0-d9a3-4423-9a5f-65fd19fad3db2023-12-27WarningsExact identifier
application number: M006
All Acne TreatmentSALICYLIC ACIDBlaine Labs Inc.ee85939e-64fc-4b18-af5b-6ebd7e14e5722023-12-21WarningsExact identifier
application number: M006
In the Clear Acne SerumSALICYLIC ACIDThe Honest Company, Incdc9e0545-43af-3d27-e053-2a95a90a52492023-12-19WarningsExact identifier
application number: M006
Spot Stopper Acne Spot TreatmentSALICYLIC ACIDThe Honest Company, Incdc7afebd-e212-b9ff-e053-2a95a90a15a52023-12-19WarningsExact identifier
application number: M006
Get Clarity Foaming Acne CleanserSULFURThe Honest Company, Incdd948b1b-d71c-1a89-e053-2a95a90a87192023-12-19WarningsExact identifier
application number: M006
Acne Med 10%BENZOYL PEROXIDEFace Reality, LLC45ad7429-ccd0-28f6-e054-00144ff88e882023-12-15WarningsExact identifier
application number: M006
Acne Face and BodyBENZOYL PEROXIDEFace Reality, Inc.454983d2-4b00-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Med 5%BENZOYL PEROXIDEFace Reality, LLC454983d2-4b11-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Face and Body WashBENZOYL PEROXIDEFace Reality Skin Care, LLC454983d2-4aec-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Med 2.5%BENZOYL PEROXIDEFace Reality, LLC454983d2-4b0f-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Nighttime ControlBENZOYL PEROXIDECircadia by Dr Pugliese, Inc.fb4cc832-4cfd-4e29-a78e-ab848681a2242023-12-15WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5056320e-e472-44ed-9afd-759ba55f0fd72023-12-13WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION418d480c-4131-4262-bb56-d5b10bbf7dcb2023-12-13WarningsExact identifier
application number: M006
Acne Advanced Clarifying MasqueSALICYLIC ACIDEminence Organic Skin Care Ltd.7916a299-fc90-4eb7-882f-4caa39e2c7aa2023-12-12WarningsExact identifier
application number: M006
Serious Skincare Continuously Clear Acne Medication For Problematic skin Dry Lo Pro All- Over TreatmentSALICYLIC ACIDFlageoli Limitedeb57517c-cf9e-4272-9c00-380385f916e02023-12-12WarningsExact identifier
application number: M006
111MedCo 6% Sulfur Skin Cleansing BarSULFUR111MedCo LLC7a2d647f-f10f-4637-b28b-319fed93677b2023-12-12WarningsExact identifier
application number: M006
111MedCo 2% Salicylic Acid Cleansing BarSALICYLIC ACID111MedCo LLC6ba7dd8f-b59f-4dfb-b55e-c7fe65a54d8a2023-12-12WarningsExact identifier
application number: M006
111 Medco Benzoyl PeroxideBENZOYL PEROXIDE111 Medco8590214e-e5a7-8934-e053-2a91aa0a248b2023-12-12WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61354-068-01613540068011 TUBE in 1 CARTON (61354-068-01) > 1 mg in 1 TUBE1 tube2022-08-250000-00-00NoNoCurrent