Home NDC 50967-357-60 PROCORT
Product NDC 50967-357
Requested package NDC 50967-357-60
11-digit product format 509670357
Labeler code 50967
Product ID 50967-357_33de5899-7f16-c8d3-e063-6394a90a27b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name 1.85% hydrocortisone acetate - 1.15% pramoxine hci cream
Dosage form CREAM
Route TOPICAL
Labeler Womens Choice Pharmaceuticals LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-06-30
Substance HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength 18.5; 11.5 mg/g; mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base PROCORT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 18.5 mg/g PRAMOXINE HYDROCHLORIDE 11.5 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 1114854 Internal RxNorm lookup 1115730 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50967-357-60 PROCORT 1 in 1 TUBE, WITH APPLICATOR CREAM 1 6 50967-357-60 PROCORT 1 in 1 CARTON CREAM 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50967-357 PROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC] 6 Current NDC, Legacy NDC, 2 package rows 20250430_9e899b72-a16e-4b55-93b5-ab5baec37d50.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50967-357-60 50967035760 1 TUBE, WITH APPLICATOR in 1 CARTON (50967-357-60) / 1 TUBE, WITH APPLICATOR in 1 TUBE, WITH APPLICATOR / 60 g in 1 TUBE, WITH APPLICATOR 2011-06-30 0000-00-00 No No Current