Pramosone
- Product NDC
- 54766-760
- 11-digit product format
- 547660760
- Labeler code
- 54766
- Product ID
- 54766-760_60636fa0-18a3-3875-e053-2a91aa0acb11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone acetate and pramoxine hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sebela Pharmaceuticals Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2015-04-14
- Marketing end
- 0000-00-00
- Substance
- HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 25 mg/g; mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 54766-760 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 54766-760 | 54766-760-03 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 54766-760 | 54766-760-04 | D | Discontinued by firm | 2026-10-16 |
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 | 54766-760-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 54766-760-03 | 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 | 54766-760-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 54766-760-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 54766-760-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 54766-760-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 54766-760-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 54766-760-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 54766-760-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 54766-760-03 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 54766-760-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 54766-760-03 | cdf11ea48f46… | ba0047e9e063… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54766-760-03 | GM - Gram | 54766-760 | 3fe789f8-a334-49f2-b3b8-d52c47073c36 | 1 | 2015-05-05 |
| 54766-760-04 | GM - Gram | 54766-760 | 68d2d5ed-2157-44dc-ad25-1f5b257c990b | 1 | 2015-05-05 |
DailyMed Socrata Ingredients#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54766-760-03 | 54766076003 | 57 g in 1 TUBE (54766-760-03) | 57 g | 2015-04-14 | 0000-00-00 | No | No | Current |
| 54766-760-04 | 54766076004 | 28.4 g in 1 TUBE (54766-760-04) | 28.4 g | 2015-04-14 | 0000-00-00 | No | No | Current |