OVACE

Product NDC
0178-0630
11-digit product format
001780630
Labeler code
0178
Product ID
0178-0630_47e8083a-60e5-b517-e063-6294a90ac104
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Mission Pharmacal Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-07
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OVACE
Brand name suffix
PLUS
Listing expiration
2027-12-31

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
48018b8f-b5bd-4cb8-9577-905211c7d53bAvailable 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
0178-0630-16OVACEPLUS473 mL in 1 BOTTLE, PLASTICLIQUID4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0630-16ML - Milliliter0178-063024ddffe1-2c14-49d8-b33a-34c90ab04b5f12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQOVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5OVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SOVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXOVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUOVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4OVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
PEG-150 PENTAERYTHRITYL TETRASTEARATEINACTIVE INGREDIENT8L4OOQ76AMOVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATEINACTIVE INGREDIENT395MHJ5PUROVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
PEG-60 ALMOND GLYCERIDESINACTIVE INGREDIENT4Y0E651N0FOVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MOVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0OVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MOVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0ROVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0630OVACE PLUS (SODIUM SULFACETAMIDE) LIQUID [MISSION PHARMACAL COMPANY]4Current NDC, Legacy NDC, 1 package rows20230830_48018b8f-b5bd-4cb8-9577-905211c7d53b.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 PLUSSODIUM SULFACETAMIDEMission Pharmacal Company48018b8f-b5bd-4cb8-9577-905211c7d53b2026-01-08Warnings, Adverse reactionsExact identifier
ndc (product): 0178-0630

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006110OVACE 10 % Medicated Liquid SoapPSN48018b8f-b5bd-4cb8-9577-905211c7d53b5
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSN48018b8f-b5bd-4cb8-9577-905211c7d53b5
1006110sulfacetamide sodium 100 MG/ML Medicated Liquid Soap [Ovace]SBD48018b8f-b5bd-4cb8-9577-905211c7d53b5
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCD48018b8f-b5bd-4cb8-9577-905211c7d53b5
1006110Ovace 10 % Medicated Liquid SoapSY48018b8f-b5bd-4cb8-9577-905211c7d53b5
1006110Ovace 100 MG/ML Medicated Liquid SoapSY48018b8f-b5bd-4cb8-9577-905211c7d53b5
1006110Ovace Plus 10 % Topical WashSY48018b8f-b5bd-4cb8-9577-905211c7d53b5
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSY48018b8f-b5bd-4cb8-9577-905211c7d53b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0630-1600178063016473 mL in 1 BOTTLE, PLASTIC (0178-0630-16) 473 ml2011-09-070000-00-00NoNoCurrent