GENTLE ACNE SERUM

Product NDC
83286-016
11-digit product format
832860016
Labeler code
83286
Product ID
83286-016_366deecd-d084-4fd1-b670-7458029ec00c
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Drmtlgy, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-02
Substance
SALICYLIC ACID
Active strength
.5 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
GENTLE ACNE SERUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
252296Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8e41339-3f3b-44ad-9b2f-1962d5f66f3dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83286-016-01GENTLE ACNE SERUM59 mL in 1 TUBEGEL591

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 25 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
humane acne washBENZOLY PEROXIDEBanner 1 LLC7674be57-7a8c-449e-9f48-2b772c58c88b2025-09-24WarningsExact identifier
application number: M006
HUMANE Maximum Strength Acne Wash 10 Benzoyl PeroxideBENZOYL PEROXIDEBanner 1 LLCf5b4d25c-af21-4698-bfa3-732ca19d40f52025-09-24WarningsExact identifier
application number: M006
HUMANE Acne Wash 5BENZOYL PEROXIDEBanner 1 LLC9e3f0fa5-9c34-4eff-93a0-606a79847b052025-09-24WarningsExact identifier
application number: M006
glo SKIN BEAUTY Spot Treat ConcealerGLO SKIN BEAUTY SPOT TREAT CONCEALERHayden Caleel LLC3f631228-484e-ff5b-e063-6394a90aca2c2025-09-22WarningsExact identifier
application number: M006
Killa Extra Strength 4 packSALICYLIC ACIDZitSticka, Inc.fce9e5fb-2a98-da4f-e053-6294a90ac9ae2025-09-18WarningsExact identifier
application number: M006
Neutrogena Evenly Clear Acne Cleansing MaskBENZOYL PEROXIDEKenvue Brands LLC3e9833b2-1814-789d-e063-6294a90abf842025-09-17WarningsExact identifier
application number: M006
Derm Solutions Salicylic Acid TreatmentSALICYLIC ACIDBCM Cosmetique SAS3ebbf1c5-4656-0239-e063-6294a90aac9e2025-09-14WarningsExact identifier
application number: M006
Curology Acne-Clearing Gel SerumSALICYLIC ACIDCurology, Inc.3e636042-56a9-142b-e063-6394a90a98592025-09-09WarningsExact identifier
application number: M006
Salicylic Acid 2% SolutionSALICYLIC ACIDDeciem39fa19ee-9cc8-8fbc-e063-6394a90a96df2025-09-09WarningsExact identifier
application number: M006
Ology Acne SpotSALICYLIC ACIDWalgreens Co.59a97686-04c0-4d53-9efd-19a1c3ece2d82025-09-05WarningsExact identifier
application number: M006
RoyceDerm Rosacea Treatment Cream.SULPHUR 1X HPUS(10%)RoyceDerm LLC3df717fc-cf2f-8a9a-e063-6394a90ae4e22025-09-04WarningsExact identifier
application number: M006
PHOFAY Salicylic Acid Acne Treatment EssenceSALICYLIC ACIDHangzhou Jingshen Trading Co., Ltd.1a03c857-1040-44ea-817d-7b472160ba6b2025-09-04WarningsExact identifier
application number: M006
BioreSALICYLIC ACIDKao USA Inc.2e1e1aa2-5d41-baa4-e063-6394a90ac3f22025-08-31WarningsExact identifier
application number: M006
Biore Pore Unclogging ScrubSALICYLIC ACIDKao USA Inc.5667307e-0bab-41c3-a2d6-5ca8605468332025-08-28WarningsExact identifier
application number: M006
PHOFAY ACNE SPOTTREATMENT CreamSALICYLIC ACIDHangzhou Jingshen Trading Co., Ltd.3d40c687-7110-46b1-e063-6394a90a84162025-08-26WarningsExact identifier
application number: M006
PHOFAY ACNE SPOT TREATMENT CreamSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd.3d0511f6-168b-5377-e063-6294a90a3ca92025-08-23WarningsExact identifier
application number: M006
PAPATUI Acne Fighting BodySALICYLIC ACIDPAPATUI, LLC3cf9ec1a-4ac3-fceb-e063-6294a90a21a02025-08-22WarningsExact identifier
application number: M006
PAPATUI Acne Fighting Facial CleanserSALICYLIC ACIDPAPATUI, LLC3cfadbb6-fc5e-5696-e063-6394a90a21f42025-08-22WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Stress Control Power Clear ScrubSALICYLIC ACIDKenvue Brands LLC3cc657cd-ad68-505a-e063-6394a90a41b22025-08-20WarningsExact identifier
application number: M006
Neutrogena Body Clear Body Wash Pink GrapefruitSALICYLIC ACIDKenvue Brands LLC3cc7eeb1-972c-25ec-e063-6294a90ae9292025-08-20WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252296salicylic acid 0.5 % Topical GelPSNa8e41339-3f3b-44ad-9b2f-1962d5f66f3d1
252296salicylic acid 0.005 MG/MG Topical GelSCDa8e41339-3f3b-44ad-9b2f-1962d5f66f3d1
252296salicylic acid 0.5 % Topical GelSYa8e41339-3f3b-44ad-9b2f-1962d5f66f3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83286-016-018328600160159 mL in 1 TUBE (83286-016-01) 59 ml2025-09-02NoNoCurrent