FDA.reportPublic FDA data

Ovace

Product NDC
0178-0620
Requested package NDC
0178-0620-02
11-digit product format
001780620
Labeler code
0178
Product ID
0178-0620_3c471b79-c192-f4cd-e063-6394a90a631f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM
Dosage form
LOTION
Route
TOPICAL
Labeler
Mission Pharmacal Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-15
Substance
SULFACETAMIDE SODIUM
Active strength
98 mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0178-06200178-0620-02DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0178-06200178-0620-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0178-06200178-0620-02DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Additional Listing Data#

Finished product
Yes
Brand name base
Ovace
Brand name suffix
Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM98 mg/g

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
1542377Internal RxNorm lookup
1542380Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
073a44cd-f679-48bd-b90d-cf06f32ff07dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0620-02OvacePlus1 in 1 CARTONLOTION110
0178-0620-02OvacePlus57 g in 1 BOTTLE, PLASTICLOTION5710
0178-0620-04OvacePlus10 in 1 CARTONLOTION1010
0178-0620-04OvacePlus4 g in 1 TUBELOTION410
0178-0620-94OvacePlus113 g in 1 BOTTLE, PLASTICLOTION11310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0620-02GM - Gram0178-0620a989f657-2043-44a2-bc39-3a6e1bda436412014-08-01
0178-0620-94GM - Gram0178-062026e7b4cb-afc0-43c5-9699-613b68e0ba6f12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
SULFACETAMIDEACTIVE MOIETY4965G3J0F5OVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999ROVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATEINACTIVE INGREDIENT395MHJ5PUROVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
WATERINACTIVE INGREDIENT059QF0KO0ROVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEOVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0620OVACE PLUS (SULFACETAMIDE SODIUM) LOTION [MISSION PHARMACAL COMPANY]9Current NDC, Legacy NDC, 5 package rows20230926_073a44cd-f679-48bd-b90d-cf06f32ff07d.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ovace PlusSULFACETAMIDE SODIUMMission Pharmacal Company073a44cd-f679-48bd-b90d-cf06f32ff07d2025-08-13Warnings, Adverse reactionsExact identifier
ndc (package): 0178-0620-02
ndc (product): 0178-0620
ndc11 (package): 00178062002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1542380Ovace Plus 9.8 % Topical LotionPSN073a44cd-f679-48bd-b90d-cf06f32ff07d10
1542377sulfacetamide sodium 9.8 % Topical LotionPSN073a44cd-f679-48bd-b90d-cf06f32ff07d10
1542380sulfacetamide sodium 98 MG/ML Topical Lotion [Ovace]SBD073a44cd-f679-48bd-b90d-cf06f32ff07d10
1542377sulfacetamide sodium 98 MG/ML Topical LotionSCD073a44cd-f679-48bd-b90d-cf06f32ff07d10
1542380Ovace 98 MG/ML Topical LotionSY073a44cd-f679-48bd-b90d-cf06f32ff07d10
1542380Ovace Plus 9.8 % Topical LotionSY073a44cd-f679-48bd-b90d-cf06f32ff07d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0620-020017806200257 g in 1 BOTTLE, PLASTIC (0178-0620-02) 57 g2011-09-150000-00-00NoNoCurrent