OVACE
- Product NDC
- 0178-0499
- 11-digit product format
- 001780499
- Labeler code
- 0178
- Product ID
- 0178-0499_47e771ab-b852-724f-e063-6394a90ac63c
- 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
- 2027-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0178-0499 | 0178-0499-12 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 0178-0499 | 0178-0499-16 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0178-0499 | 0178-0499-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0178-0499 | 0178-0499-16 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0178-0499 | 0178-0499-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0178-0499 | 0178-0499-16 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0178-0499 | 0178-0499-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0178-0499 | 0178-0499-16 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0178-0499 | 0178-0499-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0178-0499 | 0178-0499-16 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0178-0499 | 0178-0499-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0178-0499 | 0178-0499-16 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0178-0499 | 0178-0499-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0178-0499 | 0178-0499-16 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0178-0499 | 0178-0499-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0178-0499 | 0178-0499-16 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| OVACE | SULFACETAMIDE SODIUM | Mission Pharmacal Company | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 2026-01-08 | Warnings, Adverse reactions | 0178-0499 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OVACE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SULFACETAMIDE SODIUM | 100 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4NRT660KJQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a77aed6c-355f-44ed-ae95-78b4d1549c2b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0304b7d2-7a07-d53b-750f-36012ae6612e | Product name | 1 | 20140508 |
| 64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6 | Product name | 1 | 20140508 |
| 9ae74339-0a3d-82e9-5dd1-88bd2607bd6b | Product name | 1 | 20140508 |
| e44e38a9-2d9e-b0e2-cce9-490554639f3d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0178-0499-06 | OVACE | 180 mL in 1 BOTTLE, PLASTIC | LIQUID | 180 | 10 | |
| 0178-0499-12 | OVACE | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 10 | |
| 0178-0499-16 | OVACE | 480 mL in 1 BOTTLE, PLASTIC | LIQUID | 480 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0178-0499-06 | ML - Milliliter | 0178-0499 | 671cfa0f-fed4-4410-8634-011457fef0b8 | 1 | 2013-07-02 |
| 0178-0499-12 | ML - Milliliter | 0178-0499 | 37ef293f-d09d-488c-a90f-2c9d0bda5fa2 | 1 | 2013-02-13 |
| 0178-0499-16 | ML - Milliliter | 0178-0499 | a7863d99-5da7-40e9-bd48-dd8048df2aa7 | 1 | 2014-02-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1006110 | OVACE 10 % Medicated Liquid Soap | PSN | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 10 |
| 1006107 | sulfacetamide sodium 10 % Medicated Liquid Soap | PSN | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 10 |
| 1006110 | sulfacetamide sodium 100 MG/ML Medicated Liquid Soap [Ovace] | SBD | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 10 |
| 1006107 | sulfacetamide sodium 100 MG/ML Medicated Liquid Soap | SCD | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 10 |
| 1006110 | Ovace 10 % Medicated Liquid Soap | SY | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 10 |
| 1006110 | Ovace 100 MG/ML Medicated Liquid Soap | SY | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 10 |
| 1006110 | Ovace Plus 10 % Topical Wash | SY | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 10 |
| 1006107 | sulfacetamide sodium 10 % Medicated Liquid Soap | SY | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0178-0499-06 | 00178049906 | 180 mL in 1 BOTTLE, PLASTIC (0178-0499-06) | 180 ml | 2011-09-15 | 0000-00-00 | No | No | Current |
| 0178-0499-12 | 00178049912 | 355 mL in 1 BOTTLE, PLASTIC | 355 ml | Historical | ||||
| 0178-0499-16 | 00178049916 | 480 mL in 1 BOTTLE, PLASTIC | 480 ml | Historical |