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 32 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HQLSEY QUIT SMOKING PATCHES QUIT SMOKING PATCHES Hansen Pharmaceutical Investment Co., Limited 4ba317fb-714a-05cb-e063-6394a90a382f 2026-02-25 Warnings Exact identifier application number: M017 Advanced Pain Relief Cream With 5 % Natural Menthol MENTHOL Allure Labs 4bab9c43-86d4-dad2-e063-6394a90ac095 2026-02-25 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Patch MENTHOL, CAMPHOR, METHYL SALICYLATE Walgreen Co. 4223c74a-12fb-51a3-e063-6294a90a0deb 2026-02-25 Warnings Exact identifier application number: M017 Advanced Pain Relief Roll-On Gel With 5% Natural Menthol MENTHOL Allure Labs 4bad597f-acb2-a122-e063-6394a90a9fcf 2026-02-25 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy LIDOCAINE InterMed Laboratories Private Limited 4bade8a9-43bd-b649-e063-6294a90a81da 2026-02-25 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Strength MENTHOL EX Healthcare Inc. 4620c41a-2187-00f5-e063-6394a90a613c 2026-02-23 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Sculpt MENTHOL EX Healthcare Inc. 4620d4ca-42e4-eeae-e063-6394a90a5c84 2026-02-23 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Extra Strength MENTHOL EX Healthcare Inc. 4620ca7a-afe6-d063-e063-6394a90ab5db 2026-02-23 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Sportpharm LLC 9578b39e-3df7-4d75-abd7-f1d5524545e5 2026-02-23 Warnings Exact identifier application number: M017 0.5% LIDOCAINE BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. cf723c7b-495d-4bae-942c-561cf28af2d3 2026-02-21 Warnings Exact identifier application number: M017 Swiftalyn Numbing Cream MENTHOL 1% GENUINE INNOVATION LTD 4b2ebff2-2f50-e54b-e063-6294a90aaccb 2026-02-19 Warnings Exact identifier application number: M017 Equate Cold Therapy Pain Relieving MENTHOL Walmart Inc 46a3c9e9-5cd3-4bc4-e063-6394a90a7178 2026-02-19 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL, ZINC ACETATE Meijer, Inc. e11390ec-99a3-4ff1-a3c8-ca909f4f67b5 2026-02-19 Warnings, Adverse reactions Exact identifier application number: M017 Aloe Vera Gel LIDOCAINE HCL, MENTHOL Meijer, Inc. d0cc06c1-c0d5-42f0-82cd-8b704cbe1f46 2026-02-19 Warnings, Adverse reactions Exact identifier application number: M017 MENTHOL, CAMPHOR MENTHOL, CAMPHOR CHEMCO CORPORATION 4b1a0e6f-aa68-421c-e063-6294a90a426e 2026-02-18 Warnings Exact identifier application number: M017 Veiurkiu External Analgesic Cream LIDOCAINE BLOOMWELL GARDENS LLC 40ec5e6f-13dc-de04-e063-6294a90af5d5 2026-02-18 Warnings Exact identifier application number: M017 External Analgesic Cream with Menthol 5% MENTHOL 5% BLOOMWELL GARDENS LLC 402faa27-5305-c73d-e063-6394a90a36f2 2026-02-18 Warnings Exact identifier application number: M017 PAINGEL MENTHOL, METHYL SALICYLATE NACOR BUSINESS GROUP LLC 4b1d55e2-cf83-ffbd-e063-6294a90ad52f 2026-02-18 Warnings Exact identifier application number: M017 Alocane Anti-Itch HYDROCORTISONE 1% Quest Products, LLC 45252043-d41a-3cdd-e063-6394a90aa9e5 2026-02-18 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Medrock Pharmacy LLC 43e00e17-1a48-43db-9589-834568917bbf 2026-02-17 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