Blemfree

Product NDC
53228-003
11-digit product format
532280003
Labeler code
53228
Product ID
53228-003_46333478-c4a3-5191-e063-6394a90a4a27
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acide
Dosage form
LOTION
Route
TOPICAL
Labeler
Equibal, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-17
Substance
SALICYLIC ACID
Active strength
1500 mg/29000mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 24 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 packagepackage53228-003-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53228-003-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53228-003-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53228-003-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53228-003-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53228-003-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53228-003-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53228-003-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53228-003-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53228-003-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53228-003-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53228-003-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Blemfree
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID1500 mg/29000mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
424dba97-0d40-4801-9fec-4b80ab60f900Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53228-003-01Blemfree29000 mg in 1 TUBELOTION290007

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 36 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phisoderm Anti-Blemish Gel CleanserSALICYLIC ACIDThe Mentholatum Company9fd851bf-1113-488b-ad16-1a3ce52a87d52024-12-17WarningsExact identifier
application number: M006
Clear Proof Clarifying Cleansing Gel Acne MedicationSALICYLIC ACIDMary Kay Inc.e06a0132-cd30-4cec-ba2e-d29a120dc17a2024-12-17WarningsExact identifier
application number: M006
NAS TonerSALICYLIC ACIDBURT'S BEES, INC.bc1d65ef-2ed9-4124-e053-2a95a90acbe32024-12-17WarningsExact identifier
application number: M006
Clear Proof Blemish Control Toner Acne MedicationSALICYLIC ACIDMary Kay Inc.22ead982-2073-4df2-bc18-a2389f9425dd2024-12-17WarningsExact identifier
application number: M006
Clear Proof Acne System The Go SetBENZOYL PEROXIDE AND SALICYLIC ACIDMary Kay Inc.3ca40242-5d92-44be-9ddc-961d569bc3302024-12-17WarningsExact identifier
application number: M006
Clear Proof Acne SystemBENZOYL PEROXIDE AND SALICYLIC ACIDMary Kay Inc.fc1b28a4-a27e-4ae5-b4ac-58927d6411682024-12-17WarningsExact identifier
application number: M006
Stridex MaximumSALICYLIC ACIDBlistex Inc.a3b16d52-76a5-438b-a120-bb59ce062cc12024-12-16WarningsExact identifier
application number: M006
Dermisa Acne TreatmentBENZOYL PEROXIDEMontani Cosmetics Incd61a6354-8194-da19-e053-2995a90a7e222024-12-15WarningsExact identifier
application number: M006
OXY ADVANCED CARE 3 in 1 RETEXTURIZING CLEANSING PADSSALICYLIC ACIDThe Mentholatum Companyc36f7012-6fc7-4141-8492-6a20d3cf48682024-12-13WarningsExact identifier
application number: M006
OXY ADVANCED CARE MAXIMUM STRENGTH 3-in-1 ACNE PADSSALICYLIC ACIDThe Mentholatum Company99874117-b1f5-48bf-a1b1-3a2af9d9ae272024-12-13WarningsExact identifier
application number: M006
OXY Advanced Care Sensitive Skin Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company4967f854-d1e4-4fb6-84c7-1293f5f906302024-12-13WarningsExact identifier
application number: M006
OXY Advanced Care Soothing Cream Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company4171b8a9-7ebf-4c02-a086-87038b6c68c42024-12-13WarningsExact identifier
application number: M006
Oxy Advanced Care Rapid Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Companye613e8a6-ffed-49bc-bdc0-87606c51ffa32024-12-13WarningsExact identifier
application number: M006
OXY Advanced Care Soothing Cream Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company76fddd7e-8323-4046-8c90-2edafc3e09372024-12-13WarningsExact identifier
application number: M006
pHisoderm Clear Confidence Face ScrubSALICYLIC ACIDThe Mentholatum Companyb3213f88-9496-4c89-ab1b-225bd81891c22024-12-13WarningsExact identifier
application number: M006
pHisoderm CLEAN ANTI-BLEMISH FACIAL CLEANSERSALICYLIC ACIDThe Mentholatum Companyd2799f22-5684-4510-9141-073acf4b15342024-12-13WarningsExact identifier
application number: M006
pHisoderm CLEAN ANTI-BLEMISH BODY WASHSALICYLIC ACIDThe Mentholatum Company6c337b14-6779-4d98-b61b-c210b0fdd9262024-12-13WarningsExact identifier
application number: M006
pHisoderm CLEAN ANTI-BLEMISH BODY WASHSALICYLIC ACIDThe Mentholatum Companyd3baf470-9528-4a6d-b354-5ebe640b77742024-12-13WarningsExact identifier
application number: M006
Oxy Total Care Clarifying MoisturizerBENZOYL PEROXIDEThe Mentholatum Company4568b5d1-efde-4b2f-b7cc-8d227d05dfa12024-12-13WarningsExact identifier
application number: M006
Oxy Total Care Vitamin C SerumSALICYLIC ACIDThe Mentholatum Company29b34faa-7c74-4e79-ad47-1660a3e701a72024-12-13WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53228-003-015322800030129000 mg in 1 TUBE (53228-003-01) 29000 mg2025-12-170000-00-00NoNoCurrent