Home NDC 0394-0859 Hydrocortisone
Product NDC 0394-0859
11-digit product format 003940859
Labeler code 0394
Product ID 0394-0859_4d3f087b-6bc1-f6b1-e063-6394a90a9047
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form LOTION
Route TOPICAL
Labeler Mericon Industries
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-12
Substance HYDROCORTISONE
Active strength 1.14 g/114g
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 Hydrocortisone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 1.14 g/114g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 103403 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 0394-0859-32 Hydrocortisone 12 in 1 BOX LOTION 12 3 0394-0859-32 Hydrocortisone 114 g in 1 BOTTLE, DISPENSING LOTION 114 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0394-0859 HYDROCORTISONE LOTION [MERICON INDUSTRIES] 2 Current NDC, 2 package rows 20241228_8f351b04-8f6d-4353-9100-13a8a80d656a.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 121 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Pain Relieving Plus Turmeric Analgesic TROLAMINE SALICYLATE Walgreen Company f3a121bc-7572-49a4-9822-2b6d858c19d2 2024-10-31 Warnings Exact identifier application number: M017 dg health hydrocortisone HYDROCORTISONE Dolgencorp, LLC 27dc9e09-fc4f-4b66-a303-177725f3a513 2024-10-31 Warnings Exact identifier application number: M017 basic care hydrocortisone HYDROCORTISONE Amazon.com Services LLC f5419859-3f9f-43ff-9a3f-6aa81af044f0 2024-10-31 Warnings Exact identifier application number: M017 ARCTIC RELIEF MENTHOL, UNSPECIFIED FORM STRATUS PHARMACEUTICALS INC d27fbc17-46b7-4d52-ba29-c99b6c63144a 2024-10-31 Warnings Exact identifier application number: M017 Pain Relief Gel-Patch LIDOCAINE, MENTHOL R & Y Group, LLC fe0478d8-2f06-cd56-e053-6294a90a58e5 2024-10-30 Warnings Exact identifier application number: M017 JOINT-RITIS PAIN RELIEVING ROLL-ON MENTHOL Lifeline Naturals of America, Inc. ec5d99c4-6bba-45d1-84e0-12fb7cb31495 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving with Turmeric Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 317ec4fb-cff0-461d-9ca0-299527a3686d 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Analgesic CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Walgreen Company 3215a676-104c-43c3-aa36-b30d5b67799a 2024-10-30 Warnings Exact identifier application number: M017 Ultra-Strength Pain Relief Analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM TARGET CORPORATION 159c5a84-bf68-41dd-a2d3-bc2402037244 2024-10-30 Warnings Exact identifier application number: M017 DG Health Cold n Hot Pain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM Dolgencorp Inc 8fe13b85-ab74-42f8-a664-d3d2959921ac 2024-10-30 Warnings Exact identifier application number: M017 DEBACHERE Butt Balm After Care Antiseptic Pain Relief BENZOCAINE, BENZALKONIUM CHLORIDE DE.BACHERE USA LLC 8ba42864-69bf-455c-98d4-7f4ff94edceb 2024-10-29 Warnings Exact identifier application number: M017 Signature Care Hydrocortisone HYDROCORTISONE Safeway beefab66-b056-4bf1-b047-0780704ab87e 2024-10-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE H E B 15eb4676-5f6e-4c28-b5b9-4e45412dc37a 2024-10-29 Warnings Exact identifier application number: M017 Rael PAIN RELIEF ROLL-ON Analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM Rael, Inc. e6c49606-7c13-4dc6-a22d-ba54173ba788 2024-10-28 Warnings Exact identifier application number: M017 Monistat Care Instant Itch Relief BENZOCAINE Insight Pharmaceuticals LLC 4e9dc791-419f-4c79-aed4-760f8c17a5dd 2024-10-25 Warnings Exact identifier application number: M017 ZYLOTROL PAIN RELIEVING LIDOCAINE HCL, MENTHOL Asclemed USA, Inc. 1553351c-aee8-4c40-9548-35cce246bda9 2024-10-25 Warnings Exact identifier application number: M017 Outgro BENZOCAINE Medtech Products Inc. d6be8a1d-aca7-42b1-86da-881d42ffe8d5 2024-10-25 Warnings Exact identifier application number: M017 Monistat Complete Care Instant Itch Relief HYDROCORTISONE Insight Pharmaceuticals LLC a0f40504-6183-4f32-8d17-6586b3f386a6 2024-10-25 Warnings Exact identifier application number: M017 Boil Ease BENZOCAINE Insight Pharmaceuticals LLC bf108934-5e1a-4059-9dcf-008f52a83fab 2024-10-25 Warnings Exact identifier application number: M017 Dermarest Eczema Medicated HYDROCORTISONE Insight Pharmaceuticals LLC 0292ab62-5088-45fa-a056-70c2fcc19ef7 2024-10-25 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0394-0859-32 00394085932 12 BOTTLE, DISPENSING in 1 BOX (0394-0859-32) / 114 g in 1 BOTTLE, DISPENSING 2023-06-12 No No Current