Isomers Clear Skin Acne Treatment Gel

Product NDC
64990-601
11-digit product format
649900601
Labeler code
64990
Product ID
64990-601_9532a7db-9aab-44ae-8e35-12d0e74b8f9b
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Isomers Laboratories Inc
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-12-28
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
0 mL/mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64990-601IInactivated by FDA2026-10-05
excluded productproduct64990-601IInactivated by FDA2026-10-05
excluded productproduct64990-601IInactivated by FDA2026-10-05
excluded productproduct64990-601IInactivated by FDA2026-10-05
excluded packagepackage64990-60164990-601-01IInactivated by FDA2026-10-05
excluded packagepackage64990-60164990-601-03IInactivated by FDA2026-10-05
excluded packagepackage64990-60164990-601-04IInactivated by FDA2026-10-05
excluded packagepackage64990-60164990-601-02IInactivated by FDA2026-10-05

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 3 · 176 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64990-601-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64990-601-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64990-601-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64990-601-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64990-601-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64990-601-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64990-601-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64990-601-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64990-601-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64990-601-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64990-601-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64990-601-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64990-601-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64990-601-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64990-601-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64990-601-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64990-601-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64990-601-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64990-601-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64990-601-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64990-601-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64990-601-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64990-601-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64990-601-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64990-601-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64990-601-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64990-601-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64990-601-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64990-601-03Isomers Clear Skin Acne Treatment Gel240 mL in 1 BOTTLEGEL2405
64990-601-04Isomers Clear Skin Acne Spot Treatment30 mL in 1 BOTTLEGEL303
64990-601-01Isomers Clear Skin Acne Treatment Gel60 mL in 1 BOTTLEGEL601
64990-601-02Isomers Clear Skin Acne Treatment Gel120 mL in 1 BOTTLEGEL1201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]5
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]5
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16ISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]5
OPUNTIA FICUS-INDICAINACTIVE INGREDIENT23Z87HTQ6PISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]5
WATERINACTIVE INGREDIENT059QF0KO0RISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]5
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZISOMERS CLEAR SKIN ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZISOMERS CLEAR SKIN ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXISOMERS CLEAR SKIN ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]3
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16ISOMERS CLEAR SKIN ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]3
OPUNTIA FICUS-INDICAINACTIVE INGREDIENT23Z87HTQ6PISOMERS CLEAR SKIN ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TISOMERS CLEAR SKIN ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ISOMERS CLEAR SKIN ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IISOMERS CLEAR SKIN ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]3
WATERINACTIVE INGREDIENT059QF0KO0RISOMERS CLEAR SKIN ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]3
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
Salicylic AcidACTIVE MOIETYO414PZ4LPZISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16ISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16ISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
OPUNTIA FICUS-INDICAINACTIVE INGREDIENT23Z87HTQ6PISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
OPUNTIA FICUS-INDICAINACTIVE INGREDIENT23Z87HTQ6PISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3ISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
WATERINACTIVE INGREDIENT059QF0KO0RISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1
WaterINACTIVE INGREDIENT059QF0KO0RISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64990-601ISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]5Legacy NDC, 1 package rows20100218_7ade773b-ba2f-4f93-9808-d0a06c61faf2.zip
64990-601ISOMERS CLEAR SKIN ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]3Legacy NDC, 1 package rows20100308_bec3eaac-4b48-4fad-9ef7-19a175703673.zip
64990-601ISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1Legacy NDC, 1 package rows20100122_db02b4b0-e439-11de-8a39-0800200c9a66.zip
64990-601ISOMERS CLEAR SKIN ACNE TREATMENT GEL (SALICYLIC ACID) GEL [ISOMERS LABORATORIES INC]1Legacy NDC, 1 package rows20100122_7e955990-e4c9-11de-8a39-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSN7ade773b-ba2f-4f93-9808-d0a06c61faf25
346298salicylic acid 0.02 MG/MG Topical GelSCD7ade773b-ba2f-4f93-9808-d0a06c61faf25
346298salicylic acid 2 % Topical GelSY7ade773b-ba2f-4f93-9808-d0a06c61faf25
346298salicylic acid 2 % Topical GelPSNbec3eaac-4b48-4fad-9ef7-19a1757036733
346298salicylic acid 0.02 MG/MG Topical GelSCDbec3eaac-4b48-4fad-9ef7-19a1757036733
346298salicylic acid 2 % Topical GelSYbec3eaac-4b48-4fad-9ef7-19a1757036733
346298salicylic acid 2 % Topical GelPSN7e955990-e4c9-11de-8a39-0800200c9a661
346298salicylic acid 2 % Topical GelPSNdb02b4b0-e439-11de-8a39-0800200c9a661
346298salicylic acid 0.02 MG/MG Topical GelSCD7e955990-e4c9-11de-8a39-0800200c9a661
346298salicylic acid 0.02 MG/MG Topical GelSCDdb02b4b0-e439-11de-8a39-0800200c9a661
346298salicylic acid 2 % Topical GelSY7e955990-e4c9-11de-8a39-0800200c9a661
346298salicylic acid 2 % Topical GelSYdb02b4b0-e439-11de-8a39-0800200c9a661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64990-601-016499006010160 mL in 1 BOTTLE60 mlHistorical
64990-601-0264990060102120 mL in 1 BOTTLE120 mlHistorical
64990-601-0364990060103240 mL in 1 BOTTLE240 mlHistorical
64990-601-046499006010430 mL in 1 BOTTLE30 mlHistorical