Hydrocortisone
- Product NDC
- 68016-909
- 11-digit product format
- 680160909
- Labeler code
- 68016
- Product ID
- 68016-909_e46315b4-ba46-424c-8e11-9af25ffbe933
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- part348
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2021-05-07
- Marketing end
- 0000-00-00
- Substance
- HYDROCORTISONE
- Active strength
- 1 g/100g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- 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 | 68016-909 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 68016-909 | 68016-909-01 | 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 |
|---|---|---|---|---|---|---|---|---|
| 68016-909-01 | 68016090901 | 1 TUBE in 1 CARTON (68016-909-01) > 28 g in 1 TUBE | 1 tube | 2021-05-07 | 0000-00-00 | No | No | Current |