OVACE

Product NDC: 0178-0499
11-digit product format: 001780499
Labeler code: 0178
Product ID: 0178-0499_47e771ab-b852-724f-e063-6394a90ac63c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SULFACETAMIDE SODIUM
Dosage form: LIQUID
Route: TOPICAL
Labeler: Mission Pharmacal Company
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-09-15
Substance: SULFACETAMIDE SODIUM
Active strength: 100 mg/mL
Pharmacologic classes: Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 package	package	0178-0499	0178-0499-12	D	Discontinued by firm		2026-08-17
excluded package	package	0178-0499	0178-0499-16	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0178-0499-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0178-0499-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0178-0499-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0178-0499-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0178-0499-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0178-0499-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0178-0499-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0178-0499-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0178-0499-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0178-0499-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0178-0499-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0178-0499-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0178-0499-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0178-0499-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0178-0499-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0178-0499-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0178-0499-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0178-0499-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0178-0499-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0178-0499-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0178-0499-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0178-0499-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0178-0499-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0178-0499-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: OVACE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULFACETAMIDE SODIUM	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4NRT660KJQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1006107	Internal RxNorm lookup
1006110	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
a77aed6c-355f-44ed-ae95-78b4d1549c2b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0178-0499-06	OVACE	180 mL in 1 BOTTLE, PLASTIC	LIQUID	180	10
0178-0499-12	OVACE	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355	10
0178-0499-16	OVACE	480 mL in 1 BOTTLE, PLASTIC	LIQUID	480	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0178-0499-06	ML - Milliliter	0178-0499	671cfa0f-fed4-4410-8634-011457fef0b8	1	2013-07-02
0178-0499-12	ML - Milliliter	0178-0499	37ef293f-d09d-488c-a90f-2c9d0bda5fa2	1	2013-02-13
0178-0499-16	ML - Milliliter	0178-0499	a7863d99-5da7-40e9-bd48-dd8048df2aa7	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFACETAMIDE SODIUM	ACTIVE INGREDIENT	4NRT660KJQ	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4
SULFACETAMIDE	ACTIVE MOIETY	4965G3J0F5	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4
PEG-150 PENTAERYTHRITYL TETRASTEARATE	INACTIVE INGREDIENT	8L4OOQ76AM	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES	INACTIVE INGREDIENT	GO50W2HWO8	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4
PEG-60 ALMOND GLYCERIDES	INACTIVE INGREDIENT	4Y0E651N0F	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4
SODIUM THIOSULFATE	INACTIVE INGREDIENT	HX1032V43M	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0178-0499	OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]	9	Current NDC, Legacy NDC, 3 package rows	20230908_a77aed6c-355f-44ed-ae95-78b4d1549c2b.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OVACE	SULFACETAMIDE SODIUM	Mission Pharmacal Company	a77aed6c-355f-44ed-ae95-78b4d1549c2b	2026-01-08	Warnings, Adverse reactions	Exact identifier ndc (product): 0178-0499

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4NRT660KJQ	SULFACETAMIDE SODIUM	6209-17-2	SULFACETAMIDE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1006110	OVACE 10 % Medicated Liquid Soap	PSN	a77aed6c-355f-44ed-ae95-78b4d1549c2b	10
1006107	sulfacetamide sodium 10 % Medicated Liquid Soap	PSN	a77aed6c-355f-44ed-ae95-78b4d1549c2b	10
1006110	sulfacetamide sodium 100 MG/ML Medicated Liquid Soap [Ovace]	SBD	a77aed6c-355f-44ed-ae95-78b4d1549c2b	10
1006107	sulfacetamide sodium 100 MG/ML Medicated Liquid Soap	SCD	a77aed6c-355f-44ed-ae95-78b4d1549c2b	10
1006110	Ovace 10 % Medicated Liquid Soap	SY	a77aed6c-355f-44ed-ae95-78b4d1549c2b	10
1006110	Ovace 100 MG/ML Medicated Liquid Soap	SY	a77aed6c-355f-44ed-ae95-78b4d1549c2b	10
1006110	Ovace Plus 10 % Topical Wash	SY	a77aed6c-355f-44ed-ae95-78b4d1549c2b	10
1006107	sulfacetamide sodium 10 % Medicated Liquid Soap	SY	a77aed6c-355f-44ed-ae95-78b4d1549c2b	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0178-0499-06	00178049906	180 mL in 1 BOTTLE, PLASTIC (0178-0499-06)	180 ml	2011-09-15	0000-00-00	No	No	Current
0178-0499-12	00178049912	355 mL in 1 BOTTLE, PLASTIC	355 ml					Historical
0178-0499-16	00178049916	480 mL in 1 BOTTLE, PLASTIC	480 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OVACE® Wash (sodium sulfacetamide 10%)	Mission Pharmacal Company	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	10