FDA.reportPublic FDA data

Biore

Product NDC
10596-184
11-digit product format
105960184
Labeler code
10596
Product ID
10596-184_f05bd0e7-d43c-4f5a-e053-2a95a90a00de
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
Kao USA Inc.
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-12-01
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
1 g/127g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10596-184DDiscontinued by firm2026-10-15
excluded packagepackage10596-18410596-184-10DDiscontinued by firm2026-10-15
excluded packagepackage10596-18410596-184-45DDiscontinued by firm2026-10-15
excluded packagepackage10596-18410596-184-56DDiscontinued by firm2026-10-15

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 · 48 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 packagepackage10596-184-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10596-184-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10596-184-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10596-184-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10596-184-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10596-184-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10596-184-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10596-184-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10596-184-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10596-184-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10596-184-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10596-184-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10596-184-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10596-184-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10596-184-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10596-184-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10596-184-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10596-184-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10596-184-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10596-184-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10596-184-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10596-184-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10596-184-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10596-184-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10596-184-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10596-184-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10596-184-560efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10596-184-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10596-184-45ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10596-184-56ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10596-184-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10596-184-45367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10596-184-56367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10596-184-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10596-184-45557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10596-184-56557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

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 32 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zitlox Salicylic AcneSALICYLIC ACIDASA Universal Inc. dba: SONAGE4b833d7a-f957-4e65-be5b-1771493149582025-01-06WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin CleanserGLO SKIN BEAUTY CLEAR SKIN CLEANSERHayden Caleel LLC07f51d83-e956-442c-9afa-aa987a66ae9e2025-01-05WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin Spot TreatmentGLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENTHayden Caleel LLC9f33ffc7-2727-491e-a361-7f130c81d1b12025-01-05WarningsExact identifier
application number: M006
Acne Defense Face WashSALICYLIC ACIDPacifica Beauty, LLCf43590c7-84c0-6eb8-e053-2a95a90a01a72025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body ScrubSALICYLIC ACIDPacifica Beauty, LLCf44a4fc5-3358-5966-e053-2995a90add562025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body WashSALICYLIC ACIDPacifica Beauty, LLCf45b4c77-45a3-f480-e053-2995a90a36be2025-01-03WarningsExact identifier
application number: M006
Acne Warrior Clearing AstringentSALICYLIC ACIDPacifica Beauty, LLCf44bcd96-dbf8-5718-e053-2a95a90adc342025-01-03WarningsExact identifier
application number: M006
Dry It Out Acne Spot TreatmentSALICYLIC ACIDPacifica Beauty, LLCf44c0be7-9565-0068-e053-2a95a90a97052025-01-03WarningsExact identifier
application number: M006
Pacifica Bacne WarriorSALICYLIC ACIDPacifica Beauty, LLCf2b77c4f-f181-76cb-e053-2995a90a6cc12025-01-03WarningsExact identifier
application number: M006
Clarifying BacneSALICYLIC ACIDDermalogica, LLC.eb13bf93-2554-4666-bd74-637b2eed7b502025-01-02WarningsExact identifier
application number: M006
CLN ACNE CLEANSERSALICYLIC ACID 0.5% LIQUIDTopMD Skin Care, Inc.1b2f4718-b174-9b50-e063-6394a90ac2f42025-01-02WarningsExact identifier
application number: M006
Biore Witch Hazel Pore Clarifying CleanserSALICYLIC ACIDKao USA Inc.7c107414-457b-1ab0-e053-2991aa0af55a2025-01-01WarningsExact identifier
application number: M006
Biore Blemish Fighting Ice CleanserSALICYLIC ACIDKao USA Inc.e105ed47-d161-4563-a05f-f2e245659aee2025-01-01WarningsExact identifier
application number: M006
CLENZIDERM PORE THERAPY ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC08c1a55e-a376-4cd6-896f-0ad2068a1fc02025-01-01WarningsExact identifier
application number: M006
CLENZIDERM THERAPEUTIC MOISTURIZERGLYCERINObagi Cosmeceuticals LLCd60e22e3-831e-4787-a82c-e7763c2875532025-01-01WarningsExact identifier
application number: M006
CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC268bf278-3f18-4410-b552-25baadb9f96c2025-01-01WarningsExact identifier
application number: M006
CLENZIDERM THERAPEUTICBENZOYL PEROXIDEObagi Cosmeceuticals LLCf0ad29b6-38b0-4118-a711-3c668ac801ec2025-01-01WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a932c8f-3a48-dfcd-e063-6394a90ac20b2024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a9315ce-f4da-6a1e-e063-6294a90a8f422024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a92bd47-0d91-00b9-e063-6294a90ae1d62024-12-31WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10596-184-101059601841028 g in 1 TUBE (10596-184-10) 28 g2016-12-010000-00-00NoNoCurrent
10596-184-4510596018445127 g in 1 TUBE (10596-184-45) 127 g2016-12-010000-00-00NoNoCurrent
10596-184-5610596018456159 g in 1 TUBE (10596-184-56) 159 g2016-12-010000-00-00NoNoCurrent