Home NDC 0178-0485 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base OVACE Plus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFACETAMIDE SODIUM 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4NRT660KJQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 832864 Internal RxNorm lookup 901038 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0178-0485-04 OVACE Plus 10 in 1 CARTON SHAMPOO 10 7 0178-0485-04 OVACE Plus 4 mL in 1 TUBE SHAMPOO 4 7 0178-0485-05 OVACE Plus 10 in 1 CARTON SHAMPOO 10 7 0178-0485-05 OVACE Plus 5 mL in 1 PACKET SHAMPOO 5 7 0178-0485-08 OVACE Plus 237 mL in 1 BOTTLE, PLASTIC SHAMPOO 237 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0178-0485 OVACE PLUS (SULFACETAMIDE SODIUM) SHAMPOO [MISSION PHARMACAL COMPANY] 6 Current NDC, Legacy NDC, 5 package rows 20230818_6a034465-e600-49cb-91bd-7b9ceee6ffc6.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OVACE Plus SULFACETAMIDE SODIUM Mission Pharmacal Company 6a034465-e600-49cb-91bd-7b9ceee6ffc6 2025-12-03 Warnings, Adverse reactions Exact identifier ndc (product): 0178-0485
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0178-0485-04 00178048504 10 TUBE in 1 CARTON (0178-0485-04) / 4 mL in 1 TUBE 10 tube 2011-09-15 0000-00-00 Yes No Current 0178-0485-05 00178048505 10 in 1 CARTON Historical 0178-0485-08 00178048508 237 mL in 1 BOTTLE, PLASTIC (0178-0485-08) 237 ml 2011-09-15 0000-00-00 No No Current