FDA.reportPublic FDA data

Clear Skin Acne Treatment Cleanser

Product NDC
64990-609
Requested package NDC
64990-609-11
11-digit product format
649900609
Labeler code
64990
Product ID
64990-609_4a113558-166d-4891-b16b-3444837ac9f1
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Isomers Laboratories Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-04-25
Marketing end
2022-12-22
Substance
SALICYLIC ACID
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64990-60964990-609-11DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
64990-609-092021-12-229d75b9d0-b530-f424-e053-dadaa90a57ceDRUG FACTS
64990-609-102021-12-229d75b9d0-302b-f424-e053-dadaa90a57ceDRUG FACTS
64990-609-092020-01-319d75b9d0-b530-f424-e053-dadaa90a57ceDRUG FACTS
64990-609-102020-01-319d75b9d0-302b-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
Salicylic AcidACTIVE MOIETYO414PZ4LPZCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438UCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KXCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
Glyceryl OleateINACTIVE INGREDIENT4PC054V79PCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
Lauryl GlucosideINACTIVE INGREDIENT76LN7P7UCUCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
Sorbic AcidINACTIVE INGREDIENTX045WJ989BCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
WaterINACTIVE INGREDIENT059QF0KO0RCLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) SOLUTION [ISOMERS LABORATORIES INC.]16
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]5
Salicylic AcidACTIVE MOIETYO414PZ4LPZISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]5
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KXISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]5
Glyceryl MonooleateINACTIVE INGREDIENT4PC054V79PISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]5
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]5
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]5
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]5
Sorbic AcidINACTIVE INGREDIENTX045WJ989BISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]5
WaterINACTIVE INGREDIENT059QF0KO0RISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]5
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]2
Salicylic AcidACTIVE MOIETYO414PZ4LPZISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]2
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KXISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]2
Glyceryl MonooleateINACTIVE INGREDIENT4PC054V79PISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]2
Sorbic AcidINACTIVE INGREDIENTX045WJ989BISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]2
WaterINACTIVE INGREDIENT059QF0KO0RISOMERS CLEAR SKIN ACNE TREATMENT CLEANSER (SALICYLIC ACID) LIQUID [ISOMERS LABORATORIES INC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64990-609-1164990060911240 mL in 1 BOTTLE (64990-609-11) 240 ml2019-09-042022-12-22NoNoCurrent