Home NDC 13709-316 Hydrocortisone
Product NDC 13709-316
11-digit product format 137090316
Labeler code 13709
Product ID 13709-316_1ce22733-8f6f-d7ea-e063-6294a90aa49b
Type HUMAN OTC DRUG
Nonproprietary name Anti Itch
Dosage form OINTMENT
Route TOPICAL
Labeler NeilMed Pharmaceuticals Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-17
Substance HYDROCORTISONE
Active strength .0102 g/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Hydrocortisone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE .0102 g/g
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13709-316-01 Hydrocortisone 28 g in 1 TUBE OINTMENT 28 3 13709-316-01 Hydrocortisone 1 in 1 CARTON OINTMENT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13709-316 HYDROCORTISONE (ANTI ITCH) OINTMENT [NEILMED PHARMACEUTICALS INC] 3 Current NDC, 2 package rows 20240711_031957e1-9b0c-1579-e063-6394a90aaee8.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 18 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 13709-316-01 13709031601 1 TUBE in 1 CARTON (13709-316-01) / 28 g in 1 TUBE 1 tube 2023-08-17 No No Current