OVACE Plus

Product NDC
0178-0490
Requested package NDC
0178-0490-04
11-digit product format
001780490
Labeler code
0178
Product ID
0178-0490_451129de-7294-1c17-e063-6294a90a641b
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
2026-12-31
Current FDA listing
Yes

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
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
eca5fc5d-35d0-4803-990d-1f38f860c52aAvailable 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
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0490-04OVACE Plus4 mL in 1 TUBELIQUID47
0178-0490-04OVACE Plus10 in 1 CARTONLIQUID107
0178-0490-12OVACE Plus355 mL in 1 BOTTLE, PLASTICLIQUID3557

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0490-12ML - Milliliter0178-04908b8bd164-09fa-4317-aaef-bb4160a1fe6e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQOVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
SULFACETAMIDEACTIVE MOIETY4965G3J0F5OVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SOVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXOVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IOVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
PEG-150 PENTAERYTHRITYL TETRASTEARATEINACTIVE INGREDIENT8L4OOQ76AMOVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATEINACTIVE INGREDIENT395MHJ5PUROVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
PEG-6 CAPRYLIC/CAPRIC GLYCERIDESINACTIVE INGREDIENTGO50W2HWO8OVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MOVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0OVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MOVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0ROVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEOVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0490OVACE PLUS (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]6Current NDC, Legacy NDC, 3 package rows20230830_eca5fc5d-35d0-4803-990d-1f38f860c52a.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 Companyeca5fc5d-35d0-4803-990d-1f38f860c52a2025-12-03Warnings, Adverse reactionsExact identifier
ndc (package): 0178-0490-04
ndc (product): 0178-0490
ndc11 (package): 00178049004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006110OVACE 10 % Medicated Liquid SoapPSNeca5fc5d-35d0-4803-990d-1f38f860c52a7
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSNeca5fc5d-35d0-4803-990d-1f38f860c52a7
1006110sulfacetamide sodium 100 MG/ML Medicated Liquid Soap [Ovace]SBDeca5fc5d-35d0-4803-990d-1f38f860c52a7
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCDeca5fc5d-35d0-4803-990d-1f38f860c52a7
1006110Ovace 10 % Medicated Liquid SoapSYeca5fc5d-35d0-4803-990d-1f38f860c52a7
1006110Ovace 100 MG/ML Medicated Liquid SoapSYeca5fc5d-35d0-4803-990d-1f38f860c52a7
1006110Ovace Plus 10 % Topical WashSYeca5fc5d-35d0-4803-990d-1f38f860c52a7
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSYeca5fc5d-35d0-4803-990d-1f38f860c52a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0490-040017804900410 TUBE in 1 CARTON (0178-0490-04) / 4 mL in 1 TUBE10 tube2011-09-150000-00-00YesNoCurrent