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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	82165-108		I	Inactivated by FDA		2026-10-12
excluded package	package	82165-108	82165-108-02	I	Inactivated by FDA		2026-10-12

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82165-108-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82165-108-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82165-108-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82165-108-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82165-108-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82165-108-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82165-108-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82165-108-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82165-108-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82165-108-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82165-108-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82165-108-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	82165-108-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	82165-108-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	82165-108-02	`1332a3947898…`	`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
NDC	Effective	Action	Document	Indexing SPL	Related label
82165-108-02	2024-01-30	C162847	48780-1	1030e365-5df5-111a-e063-dadaa90a10e2	Dermaline Sulfur

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82165-108-02	Acne Treatment	70.9 g in 1 JAR	OINTMENT	70.9		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82165-108	ACNE TREATMENT (DERMALINE SULFUR) OINTMENT [DERMALINE USA CORP]	2	Legacy NDC, 1 package rows	20220709_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 2 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BellamiLuxx Butt Acne Treatment Cream	SALICYLIC ACID 2%	BellamiLuxx LLC	42f3367f-40a2-5d97-e063-6294a90a6e33	2026-08-13	Warnings	Exact identifier application number: M006
Folliculitis Cream	MICONAZOLE NITRATE	Beautivity LLC	3155dd5e-621b-358e-e063-6294a90a90f8	2026-08-13	Warnings	Exact identifier application number: M006
WART REMOVER	SALICYLIC ACID	Shengnan (Guangzhou) Cosmetics Co., LTD	58d245c3-c685-5784-e063-6294a90a1e23	2026-08-12	Warnings	Exact identifier application number: M006
24 PK BLEMISH DOT	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	66e0a0a5-22b5-4c89-a949-e996071a585b	2026-08-12	Warnings	Exact identifier application number: M006
24 PK BLEMISH DOT	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	13b5a729-e265-47fd-b082-2557805d08bc	2026-08-12	Warnings	Exact identifier application number: M006
24 PK BLEMISH DOT	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	9339d7ed-6e8a-48d2-a5dd-76d395e8d265	2026-08-12	Warnings	Exact identifier application number: M006
Spot Correction	SULFUR	HydroPeptide LLC	45ec40ff-7134-085b-e054-00144ff8d46c	2026-08-12	Warnings	Exact identifier application number: M006
CLERIVY MICRODART ACNE	SALICYLIC ACID	Guhada Co., Ltd.	555e0963-025e-3731-e063-6394a90a679d	2026-08-11	Warnings	Exact identifier application number: M006
Benzoyl Peroxide	BENZOYL PEROXIDE	Malezia LLC	b1304464-bd7e-fb5d-e053-2995a90a54c4	2026-08-11	Warnings	Exact identifier application number: M006
Proactiv 10% BPO Wash	BENZOYL PEROXIDE	Alchemee, LLC	58e195bd-f062-00b8-e063-6294a90aee60	2026-08-10	Warnings	Exact identifier application number: M006
SUZANOBAGIMD Acne Cleansing Wipes	SALICYLIC ACID	Obagi Cosmeceuticals LLC	91517c5a-1653-41f3-8dfb-a9dea620765c	2026-08-10	Warnings	Exact identifier application number: M006
APUREE Prorevive Maximum Strength Antifungal	COLLOIDAL SULFUR	Guangzhou Meixi Biotechnology Co., Ltd.	58860baa-070a-7b73-e063-6294a90acdf0	2026-08-08	Warnings	Exact identifier application number: M006
DG Health Athletes Foot	TOLNAFTATE	Dolgencorp, LLC	42eb14a8-d5e0-42e1-a5a2-3f65bbfa6f3f	2026-08-07	Warnings	Exact identifier application number: M006
Acne Control Cleanser	SALICYLIC ACID	CVS Health	07cb1c7c-5188-49d5-916e-e2161b5ca3b0	2026-08-06	Warnings	Exact identifier application number: M006
PIMPLE PATCHES	PIMPLE PATCHES	Shenzhen Hengdasheng Technology Co., Ltd	584d3833-4593-94db-e063-6294a90ad3ff	2026-08-05	Warnings	Exact identifier application number: M006
ProBliva Acne Clarifying Body Wash	SALICYLIC ACID 1%	CAVTECH HOLDING LLC	57e3989f-f4f5-8b5d-e063-6394a90ac4f3	2026-07-31	Warnings	Exact identifier application number: M006
Acne Clearing Sulfur Mask	SULFUR	AcneFree, LLC	c0675282-ff00-edba-e053-2995a90ace68	2026-07-31	Warnings	Exact identifier application number: M006
Sulfur Acne Foaming Cleanser	SULFUR	Acne Free, LLC	feb82a3d-cda3-c62a-e053-6394a90ad9bb	2026-07-31	Warnings	Exact identifier application number: M006
Acne Free BLACKHEAD REMOVING SCRUB 2 Salicylic Acid with Charcoal	SALICYLIC ACID	AcneFree LLC	c9393340-8a5f-6b7c-e053-2995a90afcd9	2026-07-31	Warnings	Exact identifier application number: M006
AMBI Even and Clear Exfoliating Wash Acne Treatment	SALICYLIC ACID	AMBI ENTERPRISES, LLC	43a4712d-9a6d-4bfc-abe4-f6e81dca3549	2026-07-31	Warnings	Exact identifier application number: M006

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
70FD1KFU70	SULFUR	7704-34-9	SULFUR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313148	sulfur 10 % Topical Ointment	PSN	e273a835-0ef2-6228-e053-2995a90afb04	2
313148	sulfur 0.1 MG/MG Topical Ointment	SCD	e273a835-0ef2-6228-e053-2995a90afb04	2
313148	sulfur 10 % Topical Ointment	SY	e273a835-0ef2-6228-e053-2995a90afb04	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82165-108-02	82165010802	70.9 g in 1 JAR (82165-108-02)	70.9 g	2022-04-15	0000-00-00	No	No	Current