Home NDC 61010-5800 Hydrocortisone
Product NDC 61010-5800
11-digit product format 610105800
Labeler code 61010
Product ID 61010-5800_58f3ba80-d594-c121-e063-6294a90a5e2e
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Safetec of America, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-12-15
Substance HYDROCORTISONE
Active strength 10 mg/g
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 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 61010-5800-2 2024-02-13 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-2 2024-02-13 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-3 2024-02-13 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-3 2024-02-13 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-4 2024-02-13 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-4 2024-02-13 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-2 2024-01-30 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-2 2024-01-30 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-3 2024-01-30 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-3 2024-01-30 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-4 2024-01-30 61010-5800,Safetec First Aid 1% Hydrocortisone Cream 61010-5800-4 2024-01-30 61010-5800,Safetec First Aid 1% Hydrocortisone Cream
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-5800-1 Hydrocortisone 0.9 g in 1 POUCH CREAM 0.9 5 61010-5800-2 Hydrocortisone 144 in 1 BOX CREAM 144 5 61010-5800-3 Hydrocortisone 25 in 1 BOX CREAM 25 5 61010-5800-4 Hydrocortisone 10 in 1 BOX CREAM 10 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydrocortisone ACTIVE INGREDIENT WI4X0X7BPJ HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 Hydrocortisone ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 alcohol INACTIVE INGREDIENT 3K9958V90M HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 mineral oil INACTIVE INGREDIENT T5L8T28FGP HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 paraffin INACTIVE INGREDIENT I9O0E3H2ZE HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 PEG-150 distearate INACTIVE INGREDIENT 6F36Q0I0AC HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 petrolatum INACTIVE INGREDIENT 4T6H12BN9U HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 steareth-20 INACTIVE INGREDIENT L0Q8IK9E08 HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5800 HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.] 5 Current NDC, Legacy NDC, 4 package rows 20240214_da2b3b2c-11e0-401b-bbd2-d019271d1b3d.zip 61010-5800 CARE SCIENCE OSHA FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, IBUPROFEN, ACETAMINOPHEN, WATER) KIT [ASO LLC] 2 Current NDC, Legacy NDC 20241107_1cbace4d-fd0a-41d1-aa71-907d43620bf8.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 38 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TheraCare Muscle and Joint Gel Vanishing Scent MENTHOL 2.5% Veridian Healthcare 494d2a85-45a8-12a2-e063-6294a90a391b 2026-01-26 Warnings Exact identifier application number: M017 Lidocaine Pain Relief LIDOCAINE Trifecta Pharmaceuticals USA, LLC. 493c09d0-16d7-7413-e063-6394a90aa052 2026-01-26 Warnings Exact identifier application number: M017 Topcare Medicated Pain Relieving Patch 60ct TOPCARE PAIN RELIEF PATCH EXTRA STRENGTH Topco Associates LLC 4953c12b-ca6d-d21e-e063-6294a90ac990 2026-01-26 Warnings Exact identifier application number: M017 Dr Sabharwals MENTHOL 5% PATCH Dr. Sabharwal's Wound Care 1025b986-a1e5-701d-e063-6294a90a33fd 2026-01-24 Warnings Exact identifier application number: M017 Target Up and Up Pain Relief Menthol Topical Analgesic MENTHOL Target Corporation 4910f32f-c639-0215-e063-6394a90a1c7b 2026-01-23 Warnings Exact identifier application number: M017 Rapidol HYDROCORTISONE Pharmadel LLC 19a1f1e2-bc6b-7153-e063-6294a90ab115 2026-01-23 Warnings Exact identifier application number: M017 CVS 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct Large LIDOCAINE CVS PHARMACY, INC 4914965f-1164-e20e-e063-6294a90ac221 2026-01-23 Warnings Exact identifier application number: M017 THE GOO MEDICATED PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAMPHOR APSM PERFORMANCE, LLC db4c321c-8cdc-5a11-e053-2995a90a91a1 2026-01-23 Warnings Exact identifier application number: M017 Dr Sabharwals LIDOCAINE 4% AND MENTHOL 1% PATCH Dr. Sabharwal's Wound Care 10249d0f-5ee1-6892-e063-6394a90a967e 2026-01-23 Warnings Exact identifier application number: M017 Easment DMSO cream MENTHOL 1.00% Easment LLC 48f5544e-1cfd-864a-e063-6394a90a71f1 2026-01-22 Warnings Exact identifier application number: M017 Aveeno 1% Hydrocortisone Anti-Itch Cream HYDROCORTISONE Kenvue Brands LLC 1ac0ac4e-af76-9a3e-e063-6394a90a1269 2026-01-22 Warnings Exact identifier application number: M017 RAYO ACTIVE ICE MENTHOL, CAMPHOR Quimicas Handal de Centroamerica SA de CV 09e4a36b-020a-c5b1-e063-6394a90a3e31 2026-01-22 Warnings Exact identifier application number: M017 X-Treme Freeze COLD THERAPY GEL Dynarex Corporation 79f0802f-03ad-bf8f-e053-2991aa0ae4b5 2026-01-22 Warnings Exact identifier application number: M017 Anti Itch HYDROCORTISONE HyVee Inc ae31f1f5-db70-45cf-850e-67bfe6860748 2026-01-21 Warnings Exact identifier application number: M017 ULTRA RELIEF MENTHOL, CAMPHOR CHEMCO CORPORATION 48ea80cf-af54-ce5f-e063-6394a90ac493 2026-01-21 Warnings Exact identifier application number: M017 Healthy Back Institute Rub On Relief ANALGESIC Eagle Labs Inc. 17dff3c1-3c0b-16f6-e063-6394a90a3c05 2026-01-21 Warnings Exact identifier application number: M017 Pain Relief ANALGESIC Fullstack Fulfillment 2a433cee-8b6f-c280-e063-6394a90ae25a 2026-01-21 Exact identifier application number: M017 Walgreens Anti Itch Cream ANTI ITCH CREAM Walgreens Company b545553a-283a-48af-adc5-763758a9ff24 2026-01-21 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Lidocaine Pain Relief Cream Plus Menthol LIDOCAINE HCL, MENTHOL CVS Pharmacy 8aaffa3f-f82f-470c-902d-f366f1a66305 2026-01-21 Warnings Exact identifier application number: M017 LIGHTS Instant Sting Relief Pad BENZOCAINE Lights Medical Manufacture Co., Ltd. 28dd82a7-f360-a022-e063-6394a90a3a76 2026-01-21 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 61010-5800-1 61010580001 0.9 g in 1 POUCH 0.9 g Historical 61010-5800-2 61010580002 144 POUCH in 1 BOX (61010-5800-2) / .9 g in 1 POUCH (61010-5800-1) 144 pouch 2010-12-15 0000-00-00 No No Current 61010-5800-3 61010580003 25 POUCH in 1 BOX (61010-5800-3) / .9 g in 1 POUCH (61010-5800-1) 25 pouch 2010-12-15 0000-00-00 No No Current 61010-5800-4 61010580004 10 POUCH in 1 BOX (61010-5800-4) / .9 g in 1 POUCH (61010-5800-1) 10 pouch 2020-04-01 0000-00-00 No No Current