Sodium Sulfacetamide, Sulfur

Product NDC: 44523-612
Requested package NDC: 44523-612-60
11-digit product format: 445230612
Labeler code: 44523
Product ID: 44523-612_ef1aa01c-586e-6350-e053-2995a90aca46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM SULFACETAMIDE, SULFUR
Dosage form: CLOTH
Route: TOPICAL
Labeler: BioComp Pharma, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2009-01-01
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	44523-612	44523-612-60	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 1 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	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
44523-612-60	2024-01-30	C162847	48780-1	1030e365-1e4a-111a-e063-dadaa90a10e2	Sodium Sulfacetamide 10% and Sulfur 4% Cleansing Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44523-612-60	Sodium Sulfacetamide, Sulfur	60 in 1 CARTON	CLOTH	60		4
44523-612-60	Sodium Sulfacetamide, Sulfur	3.7 g in 1 PACKET	CLOTH	3.7		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44523-612-60	EA - Each	44523-612	ce6d2d0f-4355-42b4-896c-f8b1faebb105	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFACETAMIDE SODIUM	ACTIVE INGREDIENT	4NRT660KJQ	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
SULFACETAMIDE	ACTIVE MOIETY	4965G3J0F5	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
SULFUR	ACTIVE MOIETY	70FD1KFU70	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
LAPONITE	INACTIVE INGREDIENT	D703131383	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
SODIUM ALUMINIUM SILICATE	INACTIVE INGREDIENT	058TS43PSM	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
SODIUM THIOSULFATE	INACTIVE INGREDIENT	HX1032V43M	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44523-612	SODIUM SULFACETAMIDE, SULFUR CLOTH [BIOCOMP PHARMA, INC.]	4	Legacy NDC, 2 package rows	20221206_1ac372ac-5ded-08b1-e054-00144ff8d46c.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
1000946	sulfacetamide sodium 10 % / sulfur 4 % Medicated Pad	PSN	1ac372ac-5ded-08b1-e054-00144ff8d46c	4
1000946	sulfacetamide sodium 100 MG/ML / sulfur 40 MG/ML Medicated Pad	SCD	1ac372ac-5ded-08b1-e054-00144ff8d46c	4
1000946	sulfacetamide sodium 10 % / sulfur 4 % Medicated Pad	SY	1ac372ac-5ded-08b1-e054-00144ff8d46c	4
1000946	sulfacetamide sodium 10 % / sulfur 4 % Topical Swab	SY	1ac372ac-5ded-08b1-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44523-612-60	44523061260	60 PACKET in 1 CARTON (44523-612-60) > 3.7 g in 1 PACKET	60 packet	2009-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Sulfacetamide 10% and Sulfur 4% Cleansing Pads	BioComp Pharma, Inc.	2022-12-05	HUMAN PRESCRIPTION DRUG LABEL	4