Home NDC 83107-015 pramosone
Product NDC 83107-015
11-digit product format 831070015
Labeler code 83107
Product ID 83107-015_4d4fc681-e948-f9f1-e063-6294a90a673f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone acetate and pramoxine hydrochloride
Dosage form OINTMENT
Route TOPICAL
Labeler Legacy Pharma USA Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-03-18
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 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83107-015-01 pramosone 28.4 g in 1 TUBE OINTMENT 28.4 1
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 Legacy Pharma USA Inc. 4d4fb647-0304-f4ac-e063-6294a90af513 2026-03-18 Adverse reactions Exact identifier ndc (product): 83107-015
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83107-015-01 83107001501 28.4 g in 1 TUBE (83107-015-01) 28.4 g 2026-03-18 No No Current