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 136 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rugby Capsaicin External Analgesic CAPSAICIN Proficient Rx LP 7c733a30-5002-49e7-a6bd-7737a1d2461e 2024-02-01 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Proficient Rx LP ccb62898-b614-45b9-95ea-23e5e31893a8 2024-02-01 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE Proficient Rx LP 0b26d92f-9d0e-46d4-a8bc-75d6da5f6199 2024-02-01 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Proficient Rx LP c57d5f8e-5934-4cbb-999a-cdd55e5b105f 2024-02-01 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Proficient Rx LP 47e9fe84-bd0c-40ea-85de-e950bcacc557 2024-02-01 Warnings Exact identifier application number: M017 Joint and Muscle Pain MENTHOL Shaklee Corporation 3943824f-1f4f-4d6f-bd73-0b1be02162a5 2024-01-30 Warnings Exact identifier application number: M017 Mirakel Pain Relief Roll-On LIDOCAINE HCL Sanvio, Inc. 102f3618-13ad-37e3-e063-6294a90a8086 2024-01-30 Warnings Exact identifier application number: M017 Blistex Lip Medex PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOL Blistex Inc. 8ad39005-9419-4f1a-a1ae-2f76d212455e 2024-01-26 Warnings Exact identifier application number: M017 Point Relief Cold Spot Pain Relieving MENTHOL Fabrication Enterprises ad5d6f04-15e6-4548-95c2-32271c186bc1 2024-01-25 Warnings Exact identifier application number: M017 MIND BODY MATRIX PAIN RELIEF MENTHOL Functional Energetic, Inc. 3667dd0d-942e-4101-ba98-cb013ae77cf5 2024-01-25 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS e6d27df5-118c-4c6d-86e8-7b4401a39c76 2024-01-23 Warnings Exact identifier application number: M017 Burn First Aid BURN FIRST AID Dynarex Corporation 826e08be-dffa-5a27-e053-2a91aa0a8701 2024-01-22 Warnings Exact identifier application number: M017 Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On MENTHOL TARGET CORPORATION 0f95fc55-8665-9e89-e063-6394a90a7891 2024-01-22 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief Plus Menthol LIDOCAINE, MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 77978069-a1b4-473e-83c9-8320e00eea89 2024-01-19 Warnings Exact identifier application number: M017 ZIMS MAX FREEZE LEG CRAMPS CAMPHOR, MENTHOL KOBAYASHI Healthcare International, Inc. ba26635d-95d3-4d88-93cc-1fd4fd29fd79 2024-01-18 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health e95ebdac-9789-41c2-97da-2307e4538794 2024-01-18 Warnings Exact identifier application number: M017 Medi-First Hydrocortisone 1% HYDROCORTISONE ACETATE Unifirst First Aid Corporation bd216f5d-f304-7d8d-e053-2a95a90aa9ce 2024-01-17 Warnings Exact identifier application number: M017 Green Guard Hydrocortisone 1% HYDROCORTISONE Unifirst First Aid Corporation bd348e2a-57b1-3f17-e053-2a95a90a8bdc 2024-01-17 Warnings Exact identifier application number: M017 Pain Relief LIDOCAINE, MENTHOL HUMN Pharmaceuticals Inc 6c96f94a-e724-eab3-e053-2991aa0aab88 2024-01-17 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief LIDOCAINE Natural Essentials, Inc. 52e82e70-53b7-4ecb-be39-fe10c94cc444 2024-01-17 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