Home NDC 54766-760-04 Pramosone
Product NDC 54766-760
Requested package NDC 54766-760-04
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 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.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 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