Home NDC 71205-571 hydrocortisone
Product NDC 71205-571
11-digit product format 712050571
Labeler code 71205
Product ID 71205-571_dde90c7b-26a9-4425-89b3-49d5d6092795
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Proficient Rx LP
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-04-13
Substance HYDROCORTISONE
Active strength 1 g/100g
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 g/100g
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71205-571-01 hydrocortisone 28 g in 1 TUBE CREAM 28 3 71205-571-01 hydrocortisone 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-571 HYDROCORTISONE CREAM [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 2 package rows 20240223_47e9fe84-bd0c-40ea-85de-e950bcacc557.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 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Leader Burn Relief LIDOCAINE Cardinal Health f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 2024-02-06 Warnings Exact identifier application number: M017 Pain Relieving Petro Carbo PHENOL J.R. Watkins, LLC. 050cf17d-3be7-45b9-8524-ad82af309a0e 2024-02-06 Warnings Exact identifier application number: M017 White Cream CAMPHOR (NATURAL) AND TURPENTINE OIL J.R. Watkins, LLC. e4de0734-59d5-478c-86ea-66fc2ba003e7 2024-02-05 Warnings Exact identifier application number: M017 Pain Relieving Roll-On MENTHOL, UNSPECIFIED FORM Safetec of America, Inc. 80118260-9c88-402d-9a90-ecfe62b4b54f 2024-02-05 Warnings Exact identifier application number: M017 Pain Relieving MENTHOL, UNSPECIFIED FORM Safetec of America, Inc. df512ce6-ce1b-434d-9571-fb2e1d76e1d0 2024-02-05 Warnings Exact identifier application number: M017 Pain Relieving MENTHOL Safetec of America, Inc. 52ebf64d-095f-467e-bf51-dd8d33b58c7d 2024-02-05 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE Safetec of America, Inc. 4f4c801b-d894-4fa3-b024-6ca41a5f2a95 2024-02-04 Warnings Exact identifier application number: M017 Analgesic MENTHOL Safetec of America, Inc. 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802 2024-02-04 Warnings Exact identifier application number: M017 HAV EZ Penetrating Pain Relief MENTHOL PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC 70006efc-9cc8-4490-b28c-fcb23b1737c4 2024-02-01 Warnings Exact identifier application number: M017 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 ndc (product): 71205-571 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
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 71205-571-01 71205057101 1 TUBE in 1 CARTON (71205-571-01) / 28 g in 1 TUBE 1 tube 2021-06-02 0000-00-00 No No Current