Acne Treatment

Product NDC
82165-108
11-digit product format
821650108
Labeler code
82165
Product ID
82165-108_e3499b17-5329-9237-e053-2a95a90ac5c0
Type
HUMAN OTC DRUG
Nonproprietary name
Dermaline Sulfur
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dermaline USA corp
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-04-15
Marketing end
0000-00-00
Substance
SULFUR
Active strength
10 g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82165-108IInactivated by FDA2026-10-20
excluded packagepackage82165-10882165-108-02IInactivated by FDA2026-10-20

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 · 30 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 packagepackage82165-108-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage82165-108-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage82165-108-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage82165-108-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage82165-108-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage82165-108-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage82165-108-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82165-108-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82165-108-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage82165-108-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage82165-108-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage82165-108-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage82165-108-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage82165-108-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage82165-108-021332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82165-108-022024-01-30C16284748780-11030e365-5df5-111a-e063-dadaa90a10e2Dermaline Sulfur

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82165-108-02Acne Treatment70.9 g in 1 JAROINTMENT70.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82165-108ACNE TREATMENT (DERMALINE SULFUR) OINTMENT [DERMALINE USA CORP]2Legacy NDC, 1 package rows20220709_e273a835-0ef2-6228-e053-2995a90afb04.zip

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 47 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Oil-Free Acne Wash Salicylic AcidSALICYLIC ACIDWalgreen Company9f311567-caa2-4302-9cf8-8c341917d16e2024-06-03WarningsExact identifier
application number: M006
Walgreens Maximum Strength Acne Treatment Acne medicationBENZOYL PEROXIDEWalgreen Company72ca0ddd-9292-48c9-9189-532a1768c9b72024-06-03WarningsExact identifier
application number: M006
Derma E Acne Matte MoisturizerSALICYLIC ACIDderma e48fd8477-b880-4a31-9227-095d38a7eac52024-05-31WarningsExact identifier
application number: M006
LACTO-S ACNE TREATMENTSALICYLIC ACIDNoon Aesthetics M.R. Ltdea0c7fda-30a0-48df-8a1b-4d6098c0081e2024-05-31WarningsExact identifier
application number: M006
Derma E Acne Cleansing PadsSALICYLIC ACIDderma ec749a11f-daa1-4d76-b818-cd6509efaceb2024-05-28WarningsExact identifier
application number: M006
ULTA All Clear SERUMSALICYLIC ACIDAPR BEAUTY GROUP INC199a96c1-94b8-3de6-e063-6394a90ab4782024-05-28WarningsExact identifier
application number: M006
Crystal Clear Acne Treatment PadsSALICYLIC ACIDSkin Pharm, LLC0469b1ab-5cfb-416a-b34b-7dc6fef611ff2024-05-22WarningsExact identifier
application number: M006
Anti-Aging Blemish Control Peel PadsSALICYLIC ACIDJune Jacobs Labs, LLC18fa83ab-1712-398c-e063-6394a90a6b792024-05-21WarningsExact identifier
application number: M006
Peace Out AcneSALICYLIC ACIDPeace Out LLC.efa796e8-62a8-6c20-e053-2a95a90aef6f2024-05-20WarningsExact identifier
application number: M006
Peace Out AcneSALICYLIC ACIDPeace Out LLC.eac771e2-4c1a-3808-e053-2995a90ac5fc2024-05-20WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Pore Clearing Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.fc3abc75-5d9a-4b77-9b61-e6beba8a5cfe2024-05-09WarningsExact identifier
application number: M006
Walgreens Creamy Acne Face Wash Acne MedicationBENZOYL PEROXIDEWalgreen Company13e5396b-839b-4c08-a98f-f0a36c9a0bff2024-05-09WarningsExact identifier
application number: M006
Bubble Knock Out Acne Spot TreatmentSALICYLIC ACIDBUBBLE BEAUTY17cf44cf-55f1-86a5-e063-6294a90a35d22024-05-06WarningsExact identifier
application number: M006
Bubble Super Clear Blemish Prevention SerumSALICYLIC ACIDBUBBLE BEAUTY1790ad12-c947-ddc0-e063-6394a90a85692024-05-03WarningsExact identifier
application number: M006
Walgreens Daily Acne Cleanser- Sensitive Skin FormulaBENZOYL PEROXIDEWalgreen Companyacae5006-e647-4f00-b93a-2c0bceee14cb2024-05-01WarningsExact identifier
application number: M006
Derma E Acne Blemish Control Treatment SerumSALICYLIC ACIDderma ebf5f489d-07c6-47b8-ae76-701e7ad92e8d2024-04-30WarningsExact identifier
application number: M006
Pacifica Clear Mist Facial AcneSALICYLIC ACIDPacifica Beauty, LLC16ee1a80-d523-1d02-e063-6394a90a94592024-04-25WarningsExact identifier
application number: M006
Benzoyl PeroxideBENZOYL PEROXIDEBurel Pharmaceuticals, LLC0617d42d-511d-4c1a-a919-b37abbc14efc2024-04-24WarningsExact identifier
application number: M006
Blemish DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.f3cd004d-32f1-4888-8129-d355a4750b252024-03-24WarningsExact identifier
application number: M006
Lacura Blemish Dots Conceal and TreatSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.15c447b5-0e51-43e7-b697-683bc0e686c02024-03-20WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313148sulfur 10 % Topical OintmentPSNe273a835-0ef2-6228-e053-2995a90afb042
313148sulfur 0.1 MG/MG Topical OintmentSCDe273a835-0ef2-6228-e053-2995a90afb042
313148sulfur 10 % Topical OintmentSYe273a835-0ef2-6228-e053-2995a90afb042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82165-108-028216501080270.9 g in 1 JAR (82165-108-02) 70.9 g2022-04-150000-00-00NoNoCurrent