FDA.reportPublic FDA data

Bensal HP

Product NDC
63801-107
Requested package NDC
63801-107-01
11-digit product format
638010107
Labeler code
63801
Product ID
63801-107_5bed0a42-3787-4b47-b322-67102bbe6d64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Salicylic Acid
Dosage form
OINTMENT
Route
TOPICAL
Labeler
SMG Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1998-10-01
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
30 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage63801-10763801-107-01DDiscontinued 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 · 4 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63801-107-012024-11-20Bensal HP ® TOPICAL OINTMENT
63801-107-152024-11-20Bensal HP ® TOPICAL OINTMENT
63801-107-012024-07-30Bensal HP ® TOPICAL OINTMENT
63801-107-152024-07-30Bensal HP ® TOPICAL OINTMENT
63801-107-012024-01-30Bensal HP ® TOPICAL OINTMENT
63801-107-152024-01-30Bensal HP ® TOPICAL OINTMENT
63801-107-012021-04-08Bensal HP ® TOPICAL OINTMENT
63801-107-152021-04-08Bensal HP ® TOPICAL OINTMENT
63801-107-012021-01-29Bensal HP ® TOPICAL OINTMENT
63801-107-152021-01-29Bensal HP ® TOPICAL OINTMENT

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63801-107-01GM - Gram63801-107f3673167-7742-461a-884e-0857ed3d223712013-02-13
63801-107-09GM - Gram63801-1072999bd0d-af55-49cf-ad0e-2e88f53de57912013-02-13
63801-107-12GM - Gram63801-107f351ffdc-6b1e-46d3-b992-686663fd58ed12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZBENSAL HP (SALICYLIC ACID) OINTMENT [SMG PHARMACEUTICALS, LLC ]2
Salicylic AcidACTIVE MOIETYO414PZ4LPZBENSAL HP (SALICYLIC ACID) OINTMENT [SMG PHARMACEUTICALS, LLC ]2
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMBENSAL HP (SALICYLIC ACID) OINTMENT [SMG PHARMACEUTICALS, LLC ]2
Polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PBENSAL HP (SALICYLIC ACID) OINTMENT [SMG PHARMACEUTICALS, LLC ]2
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQBENSAL HP (SALICYLIC ACID) OINTMENT [SMG PHARMACEUTICALS, LLC ]2
Quercus rubra barkINACTIVE INGREDIENTX26K8566JXBENSAL HP (SALICYLIC ACID) OINTMENT [SMG PHARMACEUTICALS, LLC ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63801-107BENSAL HP (SALICYLIC ACID) OINTMENT [SMG PHARMACEUTICALS, LLC ]9Legacy NDC20241122_4b8ccee9-0f26-416d-a6e5-1261408df899.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63801-107-01638010107011 TUBE in 1 CARTON (63801-107-01) > 30 g in 1 TUBE1 tube1998-10-010000-00-00NoNoCurrent