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 20 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermaharmony 10% Sulfur	SULFUR	D3 Development, Inc.	c78ead80-a8ee-0b52-e053-2a95a90ab880	2025-12-01	Warnings	Exact identifier application number: M006
Dermaharmony 10% Sulfur with Tea Tree Oil	SULFUR	D3 Development, Inc.	c79005d4-0c6f-75d0-e053-2995a90a8314	2025-12-01	Warnings	Exact identifier application number: M006
Resurfacing acne swipes	SALICYLIC ACID	Oars And Alps LLC	efe14f46-c947-aea4-e053-2a95a90aad5f	2025-12-01	Warnings	Exact identifier application number: M006
EradiKate ACNE TREATMENT	SULFUR	Rare Beauty Brands Inc	44ebacf3-52c1-4896-e063-6394a90ac447	2025-12-01	Warnings	Exact identifier application number: M006
EradiKate Daily Foaming Cleanser Acne Treatment	SULFUR	Rare Beauty Brands Inc.	44ebc725-796f-71e6-e063-6294a90a69a6	2025-12-01	Warnings	Exact identifier application number: M006
ERADIKATE ACNE MARK FADING	SALICYLIC ACID	Rare Beauty Brands Inc.	44ebe505-1ce8-88cf-e063-6394a90a4baf	2025-12-01	Warnings	Exact identifier application number: M006
Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Guthy-Renker,LLC	76298090-e873-4307-8bdb-19cdab6d9ac2	2025-12-01	Warnings	Exact identifier application number: M006
Asepxia Baking Soda Acne Bar	SALICYLIC ACID	Genomma Lab USA	ded9fe59-9477-4425-8bbb-f9a49118f004	2025-12-01	Warnings	Exact identifier application number: M006
Blemish Buster Solution Acne Treatment	SULFUR	Guthy-Renker LLC	d2b9462d-7897-40a4-9022-eeb04e7d5adf	2025-12-01	Warnings	Exact identifier application number: M006
Anna Guanche MD Miracle Cream The Pimple Cream	SULFUR	Bella Cosmeceuticals, Inc.	b4562cf4-aae3-e9db-e053-2995a90a7210	2025-11-30	Warnings	Exact identifier application number: M006
Vanishing Skincare	VANISHING DRY SERUM MASK, PHASE 3	Vanish Skincare LLC	27f19c03-1a18-6c74-e063-6394a90a6e86	2025-11-28	Warnings	Exact identifier application number: M006
OUHOE CLEARFACE Overnight Acne	SALICYLIC ACID	Shantou Ouhoe Technology Co., Ltd.	2be1e888-e0a4-7db7-e063-6294a90a77d5	2025-11-27	Warnings	Exact identifier application number: M006
EELHOE Acne	SALICYLIC ACID	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	2a88a374-64bc-02a3-e063-6294a90a333e	2025-11-27	Warnings	Exact identifier application number: M006
EELHOE Mole Reduce Essence	SALICYLIC ACID	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	2f80ffc4-c945-71c9-e063-6394a90add8c	2025-11-27	Warnings	Exact identifier application number: M006
JAYSUING ACNE PATCHES	SALICYLIC ACID	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	29fb7bcc-a630-1fba-e063-6294a90a65c1	2025-11-27	Warnings	Exact identifier application number: M006
Relief	COLLOIDAL OATMEAL 1%	Era Organics, Inc.	0ad58a99-e41a-a830-e063-6294a90af9cb	2025-11-27	Warnings	Exact identifier application number: M006
Superbalm	COLLOIDAL OATMEAL 1%	Era Organics, Inc.	f5298e5e-583d-d74c-e053-2995a90affb5	2025-11-27	Warnings	Exact identifier application number: M006
OGEE CLEARGANICS TARGETED BLEMISH TREATMENT	SALICYLIC ACID ACNE MEDICATION	Ogee Inc	162831d3-7e95-62f4-e063-6394a90aef7c	2025-11-26	Warnings	Exact identifier application number: M006
EELHOE Pimple Patches	SALICYLIC ACID	Shantou Ximonth Biotechnology Co., Ltd.	ffd4972a-f9bd-44a4-9d29-cd5722696805	2025-11-26	Warnings	Exact identifier application number: M006
OUHOE PIMPLE	SALICYLIC ACID	Shantou Woodsleep Biotechnology Co., Ltd.	2a374e1c-0d21-e16c-e063-6394a90ab487	2025-11-26	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