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 42 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cortizone 10 Fast Acting Itch Relief Cooling HYDROCORTISONE Chattem, Inc. 01cd77e3-380f-4487-ae6e-3ac45355d8a4 2026-01-14 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Padagis Israel Pharmaceuticals Ltd 0174411c-1b10-4298-b820-87b24065b118 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing for Eczema HYDROCORTISONE Chattem, Inc. 31dc0f1f-ddd8-41dc-b669-b24655634d55 2026-01-14 Warnings Exact identifier application number: M017 Cortisone 10 Overnight Creme HYDROCORTISONE Chattem, Inc. ef2eda7e-d6a8-47e3-9d80-6074af6773dc 2026-01-14 Warnings Exact identifier application number: M017 CVS Pain Relief Lavender Scent MENTHOL 4% CVS 484b0833-9f8a-f155-e063-6294a90a1869 2026-01-13 Warnings Exact identifier application number: M017 EARTHS CARE ANTI-ITCH CAMPHOR (NATURAL), MENTHOL DLC Laboratories, Inc. d1eabb5f-7086-4ff0-a398-3703c9ecd441 2026-01-13 Warnings Exact identifier application number: M017 HealthWise Cold Therapy Menthol Pain Relief MENTHOL Veridian Healthcare 25e3d9cd-6ba3-4e06-8853-324b9d669248 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. 1ac2ed54-194c-4de2-8e7f-6e74ca32aa40 2026-01-13 Warnings Exact identifier application number: M017 Pain Release Joint and Arthritis Cream MENTHOL Saje Natural Business Inc. 18b24d75-17f7-1a35-e063-6394a90a55e0 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. a32b0950-3467-4e37-988d-104836af5971 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. 92eec6e7-0367-43c6-bd28-1762390a7114 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. 481a493b-0620-46ac-8228-e9964b7eb24b 2026-01-13 Warnings Exact identifier application number: M017 Restoral MENTHOL Saje Natural Business Inc. 5b6176c1-9ed9-1950-e053-2a91aa0a434e 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme Lidocaine with Eucalyptus Essential Oil LIDOCAINE HCL Chattem, Inc. 03e247b4-a2e2-4354-a018-880f1bc987fd 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme Lidocaine Foot (Diabetic) LIDOCAINE HYDROCHLORIDE Chattem, Inc. 2c33d15e-5032-46d9-bd98-5abc7df3bbe5 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Essential Oils Rosemary Mint LIDOCAINE Chattem, Inc. 9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab 2026-01-13 Warnings Exact identifier application number: M017 Capzasin HP Arthritis Pain Relief CAPSAICIN Chattem, Inc. 345c9159-0efe-436b-9068-3b717678936b 2026-01-13 Warnings Exact identifier application number: M017 Capzasin Quick Relief CAPSAICIN AND MENTHOL Chattem, Inc. d6c313a3-8dc6-4231-95b6-ac9399e1c1be 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme Pain Relieving TROLAMINE SALICYLATE Chattem, Inc. 97dd587b-ecc3-4b4b-a116-6355d3c6ea6d 2026-01-13 Warnings Exact identifier application number: M017 Dr Wellskin Numbing Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 482f25cc-dee3-c3b6-e063-6294a90a8674 2026-01-12 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