Cream
- Product NDC
- 78518-010
- 11-digit product format
- 785180010
- Labeler code
- 78518
- Product ID
- 78518-010_e923676f-3d94-e2a0-e053-2995a90af0ef
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- MONAT GLOBAL CORP
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-09-12
- Marketing end
- 0000-00-00
- Substance
- ZINC OXIDE
- Active strength
- 19 mg/100mg
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 78518-010 | D | Discontinued by firm | 2026-10-28 | ||
| excluded package | package | 78518-010 | 78518-010-01 | D | Discontinued by firm | 2026-10-28 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 78518-010-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 78518-010-01 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78518-010-01 | 2024-01-11 | C162847 | 48780-1 | 0191ceaa-690b-198a-e063-dbdaa90aec3e | BB Cream SPF 40 Broad-Spectrum Moisturizer (Vanilla) |
| 78518-010-01 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-690b-198a-e063-dbdaa90aec3e | BB Cream SPF 40 Broad-Spectrum Moisturizer (Vanilla) |
DailyMed Dashboard NDC Coverage#
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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 78518-010-01 | 78518001001 | 1 TUBE in 1 CARTON (78518-010-01) > 35 mg in 1 TUBE | 1 tube | 2022-09-12 | 0000-00-00 | No | No | Current |