FDA.reportPublic FDA data

Ovace

Product NDC
0178-0620
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#

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 packagepackage0178-06200178-0620-02DDiscontinued by firm2026-08-03
excluded packagepackage0178-06200178-0620-94DDiscontinued by firm2026-08-03

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
Ovace PlusSULFACETAMIDE SODIUMMission Pharmacal Company073a44cd-f679-48bd-b90d-cf06f32ff07d2025-08-13Warnings, Adverse reactionsExact identifier
ndc (product): 0178-0620

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

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
0178-0620-040017806200410 TUBE in 1 CARTON (0178-0620-04) / 4 g in 1 TUBE10 tube2011-09-150000-00-00NoNoCurrent
0178-0620-9400178062094113 g in 1 BOTTLE, PLASTIC113 gHistorical