Dermarest

Product NDC
63736-312
Requested package NDC
63736-312-24
11-digit product format
637360312
Labeler code
63736
Product ID
63736-312_2ac6b87c-0101-4ec7-8f54-d334656b3bd1
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Insight Pharmaceuticals LLC
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-12-20
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
3 g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63736-31263736-312-24DDiscontinued by firm2026-10-16

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 · 8 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…

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 INGREDIENTO414PZ4LPZDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
Salicylic AcidACTIVE MOIETYO414PZ4LPZDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
Green Tea LeafINACTIVE INGREDIENTW2ZU1RY8B0DERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
PanthenolINACTIVE INGREDIENTWV9CM0O67ZDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
PPG-5-Ceteth-20INACTIVE INGREDIENT4AAN25P8P4DERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
SafflowerINACTIVE INGREDIENT4VBL71TY4YDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
TrolamineINACTIVE INGREDIENT9O3K93S3TKDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1
ZincINACTIVE INGREDIENTJ41CSQ7QDSDERMAREST (SALICYLIC ACID) GEL [INSIGHT PHARMACEUTICALS LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-312-246373603122424 CARTON in 1 CASE (63736-312-24) > 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE24 carton2010-12-200000-00-00NoNoCurrent