Home NDC 47682-397 Hydrocortisone
Product NDC 47682-397
11-digit product format 476820397
Labeler code 47682
Product ID 47682-397_3e4ef6bb-27cd-4a16-e063-6394a90a1e03
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Unifirst First Aid Corporation
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-04-15
Substance HYDROCORTISONE
Active strength 10 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 10 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106258 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47682-397 HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION] 13 Current NDC, Legacy NDC, 8 package rows 20240118_69d6645e-db3c-4dc0-a9a5-e2bc963e2f28.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 135 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Leader Cooling Pain Relief Topical Analgesic MENTHOL, UNSPECIFIED FORM Cardinal Health, 110 dba LEADER fd06d17f-4dff-42a9-a84f-904809ceb981 2024-03-13 Warnings Exact identifier application number: M017 MENTHOL, CAMPHOR MENTHOL, CAMPHOR EROS GLOBAL b3495c95-ba4b-9459-e053-2a95a90a710f 2024-03-12 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 1369e70f-7a61-7078-e063-6394a90a9a88 2024-03-11 Warnings Exact identifier application number: M017 Pain Reliever Cream MENTHOL 10%, METHYL SALICYLATE 15% Trifecta Pharmaceuticals USA, LLC. 130665d6-3de8-cb91-e063-6294a90a2083 2024-03-06 Warnings Exact identifier application number: M017 Dermachange Aid Anti-Itch DIPHENHYDRAMINE HCL Private Label Beauty and Wellness 12ed906c-d028-0ff7-e063-6394a90aaa52 2024-03-05 Warnings Exact identifier application number: M017 Dermachange Cold Therapy MENTHOL Private Label Beauty and Wellness 12ef7dd8-3da3-9c87-e063-6394a90ac924 2024-03-05 Warnings Exact identifier application number: M017 Dermachange Arthritis Relief TROLAMIN SALICYLATE Private Beauty Label and Wellness 12dbfa50-1b97-f988-e063-6394a90a662c 2024-03-04 Warnings Exact identifier application number: M017 Analgesic MENTHOL Safetec of America, Inc. b0f4010c-995f-40e1-aa40-92760e697a61 2024-03-02 Warnings Exact identifier application number: M017 Icy Hot Advanced Relief CAMPHOR AND MENTHOL Chattem, Inc. 9979ff36-415b-44e4-bb10-6bf682cd00f9 2024-03-01 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC 5051b650-18a4-481e-a8d7-d41d4ae51efd 2024-02-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 2999fecb-cb15-4023-ade4-ab5822b094d5 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8 MENTHOL Amish Origins Management, LLC aaad56d5-6737-4edc-af0e-8e207695c0ec 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC b120404f-5a07-4182-bb50-d943418622da 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC 437491ca-60ff-4508-b408-f97e7152f638 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC ffe15aed-ea90-4db8-aace-d691a81c05ae 2024-02-29 Warnings Exact identifier application number: M017 LidoPro Patch LIDOCAINE, MENTHOL, AND METHYL SALICYLATE Advanced Rx Pharmacy of Tennessee, LLC 128d0ba9-bc9d-af16-e063-6394a90af5ef 2024-02-29 Warnings Exact identifier application number: M017 Leader Roll-On Cooling Pain Relief Topical Analgesic MENTHOL, UNSPECIFIED FORM Cardinal Health, 110 dba LEADER e86cba40-6b10-454d-98b3-6b547456eaad 2024-02-29 Warnings Exact identifier application number: M017 Maximum Strength Scalp Itch Relief Anti-itch HYDROCORTISONE Rite Aid 55569563-fc38-4f97-8e74-9f96e3173384 2024-02-28 Warnings Exact identifier application number: M017 Walgreens Eczema Relief HYDROCORTISONE ACETATE Walgreen Co. 4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c 2024-02-28 Warnings Exact identifier application number: M017 meijer Cold Therapy Pain Relieving analgesic MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc fb163112-d84d-418d-a410-3214c0ee4b5a 2024-02-28 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 47682-397-12 47682039712 10 in 1 BOX Historical 47682-397-35 47682039735 144 PACKET in 1 BAG (47682-397-35) / .9 g in 1 PACKET 144 packet 2017-06-30 0000-00-00 No No Current 47682-397-71 47682039771 0.9 g in 1 PACKET 0.9 g Historical 47682-397-73 47682039773 25 PACKET in 1 BOX (47682-397-73) / .9 g in 1 PACKET (47682-397-99) 25 packet 2016-06-06 0000-00-00 No No Current 47682-397-99 47682039799 0.9 g in 1 PACKET 0.9 g Historical