Clear Skin Acne Treatment

Product NDC
64990-610
Requested package NDC
64990-610-10
11-digit product format
649900610
Labeler code
64990
Product ID
64990-610_8db28e7a-1fd7-4ea3-ac5f-8c4efaff1ddb
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LOTION
Route
TOPICAL
Labeler
Isomers Laboratories Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-04-27
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 packagepackage64990-61064990-610-10DDiscontinued by firm2026-10-21

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.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZCLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
Salicylic AcidACTIVE MOIETYO414PZ4LPZCLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
C20-40 Pareth-10INACTIVE INGREDIENTTE3MZI4V3FCLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1SCLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNCLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
Dihexadecyl PhosphateINACTIVE INGREDIENT2V6E5WN99NCLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UCLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TCLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ICLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
TropoloneINACTIVE INGREDIENT7L6DL16P1TCLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12
WaterINACTIVE INGREDIENT059QF0KO0RCLEAR SKIN ACNE TREATMENT (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC.]12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64990-610-1064990061010120 mL in 1 BOTTLE, PLASTIC (64990-610-10) 120 ml2019-09-052022-12-22NoNoCurrent