SUMADAN XLT

Product NDC: 43538-192
11-digit product format: 435380192
Labeler code: 43538
Product ID: 43538-192_2d87dff1-085d-4497-850e-ea782effde19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sulfacetamide sodium, sulfur, avobenzone, octinoxate, and octisalate
Dosage form: KIT
Labeler: Medimetriks Pharmaceuticals Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2013-12-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
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	43538-192		D	Discontinued by firm		2026-10-16
excluded package	package	43538-192	43538-192-16	D	Discontinued by firm		2026-10-16

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 · 32 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43538-192-16	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43538-192-16	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43538-192-16	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43538-192-16	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43538-192-16	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43538-192-16	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43538-192-16	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43538-192-16	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43538-192-16	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43538-192-16	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43538-192-16	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43538-192-16	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43538-192-16	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43538-192-16	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43538-192-16	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43538-192-16	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

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
43538-192-16	2023-12-14	C162847	48780-1	ba0f9c33-101b-a910-e053-dadaa90a0b85	Sumadan ® (Sodium Sulfacetamide 9% & Sulfur 4.5%) WASH In a Moisturizing Novasome ® Vehicle
43538-192-16	2021-01-29	C162847	48780-1	ba0f9c33-101b-a910-e053-dadaa90a0b85	Sumadan ® (Sodium Sulfacetamide 9% & Sulfur 4.5%) WASH In a Moisturizing Novasome ® Vehicle

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43538-192-16	GM - Gram	43538-192	2b0161b2-b10a-4f5c-9a8d-d913aa9da184	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
octisalate	ACTIVE INGREDIENT	4X49Y0596W	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
sulfacetamide sodium	ACTIVE INGREDIENT	4NRT660KJQ	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
sulfur	ACTIVE INGREDIENT	70FD1KFU70	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
avobenzone	ACTIVE MOIETY	G63QQF2NOX	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
octinoxate	ACTIVE MOIETY	4Y5P7MUD51	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
octisalate	ACTIVE MOIETY	4X49Y0596W	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
sulfacetamide	ACTIVE MOIETY	4965G3J0F5	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
sulfur	ACTIVE MOIETY	70FD1KFU70	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
Alkyl (C12-15) Benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
butyloctyl salicylate	INACTIVE INGREDIENT	2EH13UN8D3	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
C13-14 isoparaffin	INACTIVE INGREDIENT	E4F12ROE70	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
caprylyl glycol	INACTIVE INGREDIENT	00YIU5438U	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
ceteth-10 phosphate	INACTIVE INGREDIENT	4E05O5N49G	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
cholesterol	INACTIVE INGREDIENT	97C5T2UQ7J	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
dihexadecyl phosphate	INACTIVE INGREDIENT	2V6E5WN99N	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
disodium oleamido MIPA-sulfosuccinate	INACTIVE INGREDIENT	0MBZ20845F	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
glyceryl stearate SE	INACTIVE INGREDIENT	FCZ5MH785I	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
green tea leaf	INACTIVE INGREDIENT	W2ZU1RY8B0	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
hexylene glycol	INACTIVE INGREDIENT	KEH0A3F75J	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
isododecane	INACTIVE INGREDIENT	A8289P68Y2	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
laureth-7	INACTIVE INGREDIENT	Z95S6G8201	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
lemon oil	INACTIVE INGREDIENT	I9GRO824LL	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
magnesium aluminum silicate	INACTIVE INGREDIENT	6M3P64V0NC	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
magnesium chloride	INACTIVE INGREDIENT	02F3473H9O	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
magnesium nitrate	INACTIVE INGREDIENT	77CBG3UN78	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
methylchloroisothiazolinone	INACTIVE INGREDIENT	DEL7T5QRPN	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
methylisothiazolinone	INACTIVE INGREDIENT	229D0E1QFA	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
niacinamide	INACTIVE INGREDIENT	25X51I8RD4	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
nonoxynol-20	INACTIVE INGREDIENT	60ZT1XYO5N	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
octoxynol-5	INACTIVE INGREDIENT	TJ327E1R1V	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
PEG-100 stearate	INACTIVE INGREDIENT	YD01N1999R	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
sodium methyl cocoyl taurate	INACTIVE INGREDIENT	JVL98CG53G	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
sodium thiosulfate	INACTIVE INGREDIENT	HX1032V43M	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	SUMADAN XLT (SULFACETAMIDE SODIUM, SULFUR, AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUMADAN XLT	Medimetriks Pharmaceuticals Inc. \| IGI Laboratories	2017-12-22	HUMAN PRESCRIPTION DRUG LABEL	2