KELSEN - SPF 30
- Product NDC
- 82626-101
- 11-digit product format
- 826260101
- Labeler code
- 82626
- Product ID
- 82626-101_db9f8cc5-b339-3b45-e053-2a95a90a1e23
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- KELSEN PRODUCTS INC
- Application
- part352
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2022-04-01
- Marketing end
- 0000-00-00
- Substance
- ZINC OXIDE
- Active strength
- 10 g/100mL
- 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 | 82626-101 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 82626-101 | 82626-101-11 | D | Discontinued by firm | 2026-10-15 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 82626-101-11 | 82626010111 | 60 mL in 1 TUBE (82626-101-11) | 60 ml | 2022-04-01 | 0000-00-00 | No | No | Current |