Home NDC 54766-763 Pramosone
Product NDC 54766-763
11-digit product format 547660763
Labeler code 54766
Product ID 54766-763_52f9fd33-b349-62c7-e063-6294a90ae7ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone acetate and pramoxine hydrochloride
Dosage form OINTMENT
Route TOPICAL
Labeler Sebela Pharmaceuticals Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-05-26
Substance HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength 10; 10 mg/g; mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pramosone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 10 mg/g PRAMOXINE HYDROCHLORIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X7931PO74 Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234317 Internal RxNorm lookup 1234322 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54766-763 PRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC 20241114_d4d85400-3bb3-11e5-830e-0002a5d5c51b.zip
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pramosone HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE Sebela Pharmaceuticals Inc. d4d85400-3bb3-11e5-830e-0002a5d5c51b 2026-05-29 Adverse reactions Exact identifier ndc (product): 54766-763
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54766-763-04 54766076304 28.4 g in 1 TUBE (54766-763-04) 28.4 g 2015-08-05 0000-00-00 No No Current