SODIUM SULFACETAMIDE, SULFUR

Product NDC: 42808-110
11-digit product format: 428080110
Labeler code: 42808
Product ID: 42808-110_c9566966-0df9-4c60-a42e-522b429ca4b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM SULFACETAMIDE, SULFUR
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Exact-Rx, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-08-01
Marketing end: 0000-00-00
Substance: SULFACETAMIDE SODIUM; SULFUR
Active strength: 100 mg/g; mg/g
Pharmacologic classes: Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42808-110		I	Inactivated by FDA	2026-10-05
excluded package	package	42808-110	42808-110-06	I	Inactivated by FDA	2026-10-05
excluded package	package	42808-110	42808-110-12	I	Inactivated by FDA	2026-10-05

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 2 · 66 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	42808-110-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42808-110-12	`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	42808-110-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42808-110-12	`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	42808-110-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42808-110-12	`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	42808-110-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42808-110-12	`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	42808-110-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42808-110-12	`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	42808-110-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42808-110-12	`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	42808-110-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42808-110-12	`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	42808-110-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42808-110-12	`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	42808-110-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42808-110-12	`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	42808-110-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42808-110-12	`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	42808-110-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42808-110-12	`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	42808-110-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42808-110-12	`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	42808-110-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42808-110-12	`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	42808-110-06	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42808-110-12	`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	42808-110-06	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42808-110-12	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42808-110-12	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42808-110-06	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42808-110-12	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42808-110-06	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42808-110-12	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42808-110-06	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42808-110-12	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42808-110-06	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42808-110-12	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42808-110-06	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4073022c-5d5d-48f5-82ed-091ad146a4b2	Product name	1	20171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5	Product name	1	20150828
0304b7d2-7a07-d53b-750f-36012ae6612e	Product name	1	20140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42808-110-06	2019-11-13	C162847	48780-1	97449f38-c7e8-f6ea-e053-dbdaa90aa703	Sodium Sulfacetamide 10% and Sulfur 5% Cleanser Rx only
42808-110-12	2019-11-13	C162847	48780-1	97449f38-c7e8-f6ea-e053-dbdaa90aa703	Sodium Sulfacetamide 10% and Sulfur 5% Cleanser Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42808-110-06	SODIUM SULFACETAMIDE, SULFUR	170 g in 1 TUBE	SOLUTION	170	1
42808-110-12	SODIUM SULFACETAMIDE, SULFUR	2 in 1 CARTON	SOLUTION	2	1
42808-110-12	SODIUM SULFACETAMIDE, SULFUR	170 g in 1 TUBE	SOLUTION	170	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42808-110-06	GM - Gram	42808-110	2aff59d6-33fd-4084-9743-46a2ee43df15	1	2012-07-24
42808-110-12	GM - Gram	42808-110	84e8e26c-5103-4b40-bb94-1b770d3b7f06	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFACETAMIDE SODIUM	ACTIVE INGREDIENT	4NRT660KJQ	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
SULFACETAMIDE	ACTIVE MOIETY	4965G3J0F5	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
SULFUR	ACTIVE MOIETY	70FD1KFU70	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
DISODIUM LAURETH SULFOSUCCINATE	INACTIVE INGREDIENT	D6DH1DTN7E	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
SODIUM COCOYL ISETHIONATE	INACTIVE INGREDIENT	518XTE8493	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
SODIUM LAURYL SULFOACETATE	INACTIVE INGREDIENT	D0Y70F2B9J	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
SODIUM THIOSULFATE	INACTIVE INGREDIENT	HX1032V43M	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42808-110	SODIUM SULFACETAMIDE, SULFUR SOLUTION [EXACT-RX, INC.]	1	Legacy NDC, 3 package rows	20111020_c9566966-0df9-4c60-a42e-522b429ca4b5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4NRT660KJQ	SULFACETAMIDE SODIUM	6209-17-2	SULFACETAMIDE SODIUM
70FD1KFU70	SULFUR	7704-34-9	SULFUR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
999613	sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid Soap	PSN	c9566966-0df9-4c60-a42e-522b429ca4b5	1
999613	sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid Soap	SCD	c9566966-0df9-4c60-a42e-522b429ca4b5	1
999613	sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid Soap	SY	c9566966-0df9-4c60-a42e-522b429ca4b5	1
999613	sulfacetamide sodium 10 % / sulfur 5 % Topical Cleanser	SY	c9566966-0df9-4c60-a42e-522b429ca4b5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42808-110-06	42808011006	170 g in 1 TUBE	170 g	Historical
42808-110-12	42808011012	2 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Sulfacetamide 10% and Sulfur 5% Cleanser Rx only	Exact-Rx, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	1