FDA.reportPublic FDA data

OVACE Plus

Product NDC
0178-0485
11-digit product format
001780485
Labeler code
0178
Product ID
0178-0485_45116f40-1802-b712-e063-6394a90a8712
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM
Dosage form
SHAMPOO
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
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 packagepackage0178-04850178-0485-05DDiscontinued by firm2026-07-31

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 Company6a034465-e600-49cb-91bd-7b9ceee6ffc62025-12-03Warnings, Adverse reactionsExact identifier
ndc (product): 0178-0485

Additional Listing Data#

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

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
832864Internal RxNorm lookup
901038Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a034465-e600-49cb-91bd-7b9ceee6ffc6Available 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
0178-0485-04OVACE Plus10 in 1 CARTONSHAMPOO107
0178-0485-04OVACE Plus4 mL in 1 TUBESHAMPOO47
0178-0485-05OVACE Plus10 in 1 CARTONSHAMPOO107
0178-0485-05OVACE Plus5 mL in 1 PACKETSHAMPOO57
0178-0485-08OVACE Plus237 mL in 1 BOTTLE, PLASTICSHAMPOO2377

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0485-08ML - Milliliter0178-04857658dc20-0fee-42eb-b56c-2b708a20f52012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
SULFACETAMIDEACTIVE MOIETY4965G3J0F5OVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATEINACTIVE INGREDIENT395MHJ5PUROVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0OVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0ROVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0485OVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY]6Current NDC, Legacy NDC, 5 package rows20230818_6a034465-e600-49cb-91bd-7b9ceee6ffc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901038OVACE Plus 10 % Medicated ShampooPSN6a034465-e600-49cb-91bd-7b9ceee6ffc67
832864sulfacetamide sodium 10 % Medicated ShampooPSN6a034465-e600-49cb-91bd-7b9ceee6ffc67
901038sulfacetamide sodium 100 MG/ML Medicated Shampoo [Ovace]SBD6a034465-e600-49cb-91bd-7b9ceee6ffc67
832864sulfacetamide sodium 100 MG/ML Medicated ShampooSCD6a034465-e600-49cb-91bd-7b9ceee6ffc67
901038Ovace 100 MG/ML Medicated ShampooSY6a034465-e600-49cb-91bd-7b9ceee6ffc67
901038Ovace Plus 10 % Medicated ShampooSY6a034465-e600-49cb-91bd-7b9ceee6ffc67
832864sulfacetamide sodium 10 % Medicated ShampooSY6a034465-e600-49cb-91bd-7b9ceee6ffc67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0485-040017804850410 TUBE in 1 CARTON (0178-0485-04) / 4 mL in 1 TUBE10 tube2011-09-150000-00-00YesNoCurrent
0178-0485-050017804850510 in 1 CARTONHistorical
0178-0485-0800178048508237 mL in 1 BOTTLE, PLASTIC (0178-0485-08) 237 ml2011-09-150000-00-00NoNoCurrent