Renu Laboratories Acne Sulphur L

Product NDC: 76348-450
11-digit product format: 763480450
Labeler code: 76348
Product ID: 76348-450_4616a187-4faa-181d-e063-6294a90ae910
Type: HUMAN OTC DRUG
Nonproprietary name: Acne Sulfur Lotion
Dosage form: SUSPENSION
Route: TOPICAL
Labeler: Renu Laboratories, LLC
Application: M006
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-04-16
Substance: SULFUR
Active strength: 1.4 g/14g
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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76348-450-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76348-450-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76348-450-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76348-450-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76348-450-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76348-450-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76348-450-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76348-450-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76348-450-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Renu Laboratories Acne Sulphur L
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULFUR	1.4 g/14g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
70FD1KFU70	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
240725	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
13de0e4c-b134-41c0-e054-00144ff88e88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-450-02	2025-12-16	C162847	48780-1	2cef2736-7299-d83d-e063-dadaa90ab31f	Sulfur Lotion
76348-450-02	2025-01-30	C162847	48780-1	2cef2736-7299-d83d-e063-dadaa90ab31f	Sulfur Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-450-02	Renu Laboratories Acne Sulphur L	56 g in 1 BOTTLE, GLASS	SUSPENSION	56		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]	2
SULFUR	ACTIVE MOIETY	70FD1KFU70	RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]	2
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]	2
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]	2
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]	2
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-450	RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20220118_13de0e4c-b134-41c0-e054-00144ff88e88.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 4 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SERYNTH MILIA REMOVER	SALICYLIC ACID 1% MILIA REMOVER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c3bfa-32ec-c0dd-e063-6394a90ab15c	2026-07-21	Warnings	Exact identifier application number: M006
OURUI ONE FACIAL BUMP REFINING ESSENCE	SALICYLIC ACID 0.25% FACIAL BUMP REFINING ESSENCE	Jiangxi Yudexi Pharmaceutical Co., LTD	4959bb67-063f-ffa4-e063-6394a90aa01f	2026-07-20	Warnings	Exact identifier application number: M006
Beilloso FACIAL BUMP REFINING ESSENCE	SALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a461a7a-f5cf-6544-e063-6294a90a00f2	2026-07-20	Warnings	Exact identifier application number: M006
Lepnuns MILIA REMOVER	DIDECYL DIMETHYL AMMONIUM CHLORIDE 0.025% MILIA REMOVER	Jiangxi Yudexi Pharmaceutical Co., LTD	497ed53c-2562-b370-e063-6294a90a5ba1	2026-07-20	Warnings	Exact identifier application number: M006
Good Molecules Acne Foaming Cleanser	SALICYLIC ACID	Good Molecules, LLC	44fa9eda-0910-7d70-e063-6394a90af3a7	2026-07-20	Warnings	Exact identifier application number: M006
Good Molecules Acne Foaming Cleanser	SALICYLIC ACID	Good Molecules	dec189a2-5f93-7c3e-e053-2a95a90af988	2026-07-20	Warnings	Exact identifier application number: M006
Clean and Clear Essentials Acne Toner	SALICYLIC ACID	Kenvue Brands LLC	06cd03e3-6146-65d8-e063-6294a90a1701	2026-07-17	Warnings	Exact identifier application number: M006
24 Hour Acne Serum	BENZOYL PEROXIDE	Drmtlgy, LLC	55507941-dbdf-4e5f-a74d-4da6f67b6a1f	2026-07-17	Warnings	Exact identifier application number: M006
PCA Skin Acne Control Prebiotic Cleanser	SALICYLIC ACID	CP Skin Health Group, Inc.	56bca675-3e59-815a-e063-6294a90a1d87	2026-07-16	Warnings	Exact identifier application number: M006
Acne patches	ACNE PATCHES	Shenzhen Hengdasheng Technology Co., Ltd	5664b9c4-6ae3-4f64-e063-6294a90a825a	2026-07-14	Warnings	Exact identifier application number: M006
Zmztuhua Folliculitis Treatment Cream	BENZOYL PEROXIDE	Guangzhou Hechuang Commercial Service Co.,Ltd.	567ceafc-b75a-9777-e063-6394a90ae160	2026-07-13	Warnings	Exact identifier application number: M006
Magnilife Eczema Care	SULFUR, GRAPHITE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS WHOLE	The Magni Group, Inc.	8e3fc743-4c82-4a03-a963-2d5f93a1bc26	2026-07-13	Warnings	Exact identifier application number: M006
PHYLA ACNE PHAGE SERUM	SALICYLIC ACID	COSMAX USA, CORP	564abe82-c983-6a98-e063-6394a90a14a0	2026-07-10	Warnings	Exact identifier application number: M006
GOOD MOLECULE MAXIMUM STRENGHT ACNE	SALICYLIC ACID	COSMAX USA, CORP	564aafc0-1a06-1cba-e063-6294a90ae738	2026-07-10	Warnings	Exact identifier application number: M006
Touch Acne Treatment Benzoyl Peroxide	BENZOYL PEROXIDE	Diractions Capital LLC	1ae4e081-b04a-407d-992d-cd398f3afc54	2026-07-10	Warnings	Exact identifier application number: M006
Drs. ACNE SPOT TREATMENT	SALICYLIC ACID	OL PHARMA TECH, LLC Drs. PHARMACY	161b2306-364a-e1b8-e063-6394a90a6c88	2026-07-09	Warnings	Exact identifier application number: M006
Proactiv Acne Body Wash	SALICYLIC ACID	Alchemee, LLC	36aef223-6a4a-433f-b292-631e6068b17f	2026-07-08	Warnings	Exact identifier application number: M006
Ladoverna	BENZOYL PEROXIDE CREAM	Guangzhou Oupeng Cosmetics Co., Ltd.	55b0f9fd-9055-6969-e063-6294a90a1a7d	2026-07-07	Warnings	Exact identifier application number: M006
L BRI Klearaway	SALICYLIC ACID	L'BRI Health & Beauty	b9aa1c48-b767-47b0-bb98-efb7e860ab36	2026-07-06	Warnings	Exact identifier application number: M006
L BRI Deep Clean Toner	SALICYLIC ACID	L'BRI Health & Beauty	607fb6d0-ae49-472c-9224-0673af934bd2	2026-07-06	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
240725	sulfur 10 % Topical Lotion	PSN	13de0e4c-b134-41c0-e054-00144ff88e88	6
240725	sulfur 100 MG/ML Topical Lotion	SCD	13de0e4c-b134-41c0-e054-00144ff88e88	6
240725	sulfur 10 % Topical Lotion	SY	13de0e4c-b134-41c0-e054-00144ff88e88	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76348-450-02	76348045002	56 g in 1 BOTTLE, GLASS (76348-450-02)	56 g	2015-04-16	0000-00-00	No	No	Current