Home NDC 13709-317 Hydrocortisone with aloe
Product NDC 13709-317
11-digit product format 137090317
Labeler code 13709
Product ID 13709-317_1ce25285-5f43-da63-e063-6394a90ab690
Type HUMAN OTC DRUG
Nonproprietary name hydrocortisone with Aloe Anti Itch
Dosage form CREAM
Route TOPICAL
Labeler NeilMed Pharmaceuticals Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-18
Substance HYDROCORTISONE
Active strength 10.2 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 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 with aloe
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10.2 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII 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 13709-317-01 Hydrocortisone with aloe 28 g in 1 TUBE CREAM 28 4 13709-317-01 Hydrocortisone with aloe 1 in 1 CARTON CREAM 1 4 13709-317-02 Hydrocortisone with aloe 1 in 1 CARTON CREAM 1 4 13709-317-02 Hydrocortisone with aloe 56 g in 1 TUBE CREAM 56 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13709-317 HYDROCORTISONE WITH ALOE (HYDROCORTISONE WITH ALOE ANTI ITCH) CREAM [NEILMED PHARMACEUTICALS INC.] 4 Current NDC, 4 package rows 20240711_032b9f58-5f64-04dd-e063-6294a90a6bb9.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 13709-317-01 13709031701 1 TUBE in 1 CARTON (13709-317-01) / 28 g in 1 TUBE 1 tube 2023-08-18 No No Current 13709-317-02 13709031702 1 TUBE in 1 CARTON (13709-317-02) / 56 g in 1 TUBE 1 tube 2023-08-18 No No Current