FDA.reportPublic FDA data

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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0178-04990178-0499-12DDiscontinued by firm2026-08-03
excluded packagepackage0178-04990178-0499-16DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 14 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0178-04990178-0499-12DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0178-04990178-0499-16DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0178-04990178-0499-12DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0178-04990178-0499-16DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0178-04990178-0499-12DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0178-04990178-0499-16DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0178-04990178-0499-12DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0178-04990178-0499-16DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0178-04990178-0499-12DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0178-04990178-0499-16DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0178-04990178-0499-12DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0178-04990178-0499-16DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0178-04990178-0499-12DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0178-04990178-0499-16DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OVACESULFACETAMIDE SODIUMMission Pharmacal Companya77aed6c-355f-44ed-ae95-78b4d1549c2b2026-01-08Warnings, Adverse reactionsExact identifier
ndc (product): 0178-0499

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NRT660KJQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1006107Internal RxNorm lookup
1006110Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a77aed6c-355f-44ed-ae95-78b4d1549c2bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0499-06OVACE180 mL in 1 BOTTLE, PLASTICLIQUID18010
0178-0499-12OVACE355 mL in 1 BOTTLE, PLASTICLIQUID35510
0178-0499-16OVACE480 mL in 1 BOTTLE, PLASTICLIQUID48010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0499-06ML - Milliliter0178-0499671cfa0f-fed4-4410-8634-011457fef0b812013-07-02
0178-0499-12ML - Milliliter0178-049937ef293f-d09d-488c-a90f-2c9d0bda5fa212013-02-13
0178-0499-16ML - Milliliter0178-0499a7863d99-5da7-40e9-bd48-dd8048df2aa712014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQOVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4
SULFACETAMIDEACTIVE MOIETY4965G3J0F5OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXOVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4
PEG-150 PENTAERYTHRITYL TETRASTEARATEINACTIVE INGREDIENT8L4OOQ76AMOVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4
PEG-6 CAPRYLIC/CAPRIC GLYCERIDESINACTIVE INGREDIENTGO50W2HWO8OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4
PEG-60 ALMOND GLYCERIDESINACTIVE INGREDIENT4Y0E651N0FOVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MOVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4
WATERINACTIVE INGREDIENT059QF0KO0ROVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0499OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]9Current NDC, Legacy NDC, 3 package rows20230908_a77aed6c-355f-44ed-ae95-78b4d1549c2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006110OVACE 10 % Medicated Liquid SoapPSNa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSNa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006110sulfacetamide sodium 100 MG/ML Medicated Liquid Soap [Ovace]SBDa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCDa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006110Ovace 10 % Medicated Liquid SoapSYa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006110Ovace 100 MG/ML Medicated Liquid SoapSYa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006110Ovace Plus 10 % Topical WashSYa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSYa77aed6c-355f-44ed-ae95-78b4d1549c2b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0499-0600178049906180 mL in 1 BOTTLE, PLASTIC (0178-0499-06) 180 ml2011-09-150000-00-00NoNoCurrent
0178-0499-1200178049912355 mL in 1 BOTTLE, PLASTIC355 mlHistorical
0178-0499-1600178049916480 mL in 1 BOTTLE, PLASTIC480 mlHistorical