FDA.reportPublic FDA data

OvacePlus

Product NDC
0178-0495
11-digit product format
001780495
Labeler code
0178
Product ID
0178-0495_3c3321a2-fd6d-24eb-e063-6394a90ab4dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM
Dosage form
CREAM
Route
TOPICAL
Labeler
Mission Pharmacal Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-15
Substance
SULFACETAMIDE SODIUM
Active strength
100 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0178-04950178-0495-02DDiscontinued 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
OvacePlus PlusSULFACETAMIDE SODIUMMission Pharmacal Company06876575-edf2-4844-8f20-3eb6e74ccc8e2025-08-12Warnings, Adverse reactionsExact identifier
ndc (product): 0178-0495

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 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
1006683Internal RxNorm lookup
1006684Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
06876575-edf2-4844-8f20-3eb6e74ccc8eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0178-0495-02OvacePlusPlus57 g in 1 BOTTLE, PLASTICCREAM579
0178-0495-02OvacePlusPlus1 in 1 CARTONCREAM19
0178-0495-04OvacePlusPlus4 g in 1 TUBECREAM49
0178-0495-04OvacePlusPlus10 in 1 CARTONCREAM109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0495-02GM - Gram0178-04954b12849d-006d-48aa-b1a5-a8282a94121e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
SULFACETAMIDEACTIVE MOIETY4965G3J0F5OVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999ROVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATEINACTIVE INGREDIENT395MHJ5PUROVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
WATERINACTIVE INGREDIENT059QF0KO0ROVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEOVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0495OVACEPLUS PLUS (SULFACETAMIDE SODIUM) CREAM [MISSION PHARMACAL COMPANY]8Current NDC, Legacy NDC, 4 package rows20230926_06876575-edf2-4844-8f20-3eb6e74ccc8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006684Ovace Plus 10 % Topical CreamPSN06876575-edf2-4844-8f20-3eb6e74ccc8e9
1006683sulfacetamide sodium 10 % Topical CreamPSN06876575-edf2-4844-8f20-3eb6e74ccc8e9
1006684sulfacetamide sodium 100 MG/ML Topical Cream [Ovace]SBD06876575-edf2-4844-8f20-3eb6e74ccc8e9
1006683sulfacetamide sodium 100 MG/ML Topical CreamSCD06876575-edf2-4844-8f20-3eb6e74ccc8e9
1006684Ovace 100 MG/ML Topical CreamSY06876575-edf2-4844-8f20-3eb6e74ccc8e9
1006684Ovace Plus 10 % Topical CreamSY06876575-edf2-4844-8f20-3eb6e74ccc8e9
1006683sulfacetamide sodium 10 % Topical CreamSY06876575-edf2-4844-8f20-3eb6e74ccc8e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0495-020017804950257 g in 1 BOTTLE, PLASTIC (0178-0495-02) 57 g2011-09-150000-00-00NoNoCurrent
0178-0495-040017804950410 TUBE in 1 CARTON (0178-0495-04) / 4 g in 1 TUBE10 tube2011-09-150000-00-00YesNoCurrent