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 100 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Reliveing Patch LIDOCAINE 4% simple diagnostics 02ed0b27-bba9-ec0c-e063-6294a90a014d 2025-02-07 Warnings Exact identifier application number: M017 FlexDermal Pain Relieving Roll-On MENTHOL SOLVADERM LLC d4d8050e-0761-4491-8635-39c806701eb5 2025-02-06 Warnings Exact identifier application number: M017 Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE Clarion Brands LLC 2d7e9f6a-0f21-b103-e063-6294a90a912f 2025-02-06 Warnings Exact identifier application number: M017 signature care Hydrocortisone HYDROCORTISONE Safeway 9fe16fc5-77e3-47f5-a943-85bc6565c0d4 2025-02-06 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 2d685602-5cd6-3b36-e063-6394a90a3c5d 2025-02-05 Warnings Exact identifier application number: M017 Lidocore LIDOCAINE iON Pharma, LLC 204c3e50-1ac8-f442-e063-6294a90ae7b5 2025-02-05 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream Extreme MENTHOL 16%, CAMPHOR 11% Telebrands Corp 2d54077e-4c8d-aaae-e063-6394a90adb41 2025-02-04 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN NuCare Pharmaceuticals,Inc. fd90a67d-d60d-a849-e053-6394a90a2cc8 2025-02-04 Warnings Exact identifier application number: M017 Rugby Muscle Rub Cream MUSCLE RUB CREAM NuCare Pharmaceuticals, Inc. 2d58c15a-5ddb-1b16-e063-6294a90a3fbb 2025-02-04 Warnings Exact identifier application number: M017 Cetilar MENTHOL 1.4% PharmaNutra Usa Corp. 2dd14bd4-b4e1-bc7d-e063-6394a90a1e59 2025-02-04 Warnings Exact identifier application number: M017 Stopain Extra Strength Continuous MENTHOL Troy Manufacturing, Inc. 0d199d39-5b47-4c7f-b83a-757f39aa17b6 2025-02-03 Warnings Exact identifier application number: M017 TheraCare Pain Relieving Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 2d42192b-8889-a896-e063-6294a90a4fc8 2025-02-03 Warnings Exact identifier application number: M017 Tiger Balm Pain Relieving Muscle METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) Haw Par Healthcare Ltd. 96b06d3f-8685-4314-ad7d-5d2720f4dde6 2025-02-03 Warnings Exact identifier application number: M017 Icy Hot Medicated No Mess Applicator MENTHOL Chattem, Inc. 4ce2b823-7ef5-4cca-a2d8-2fe781bc958e 2025-02-01 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing Itch Relief Cream HYDROCORTISONE Chattem, Inc. cdbeb825-3152-4f74-9fd1-93bccfc0e31a 2025-02-01 Warnings Exact identifier application number: M017 Cortizone 10 Soothing Aloe Itch Relief HYDROCORTISONE Chattem, Inc. 1962abb3-6ca7-4934-9efe-20287b1c2a5b 2025-02-01 Warnings Exact identifier application number: M017 myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol MENTHOL Inspec Solutions LLC d4276749-eeff-28f7-e053-2a95a90a593d 2025-01-31 Warnings Exact identifier application number: M017 MyDerm Bite Relief BENZOCAINE Inspec Solutions LLC. 88615668-16b5-7840-e053-2a95a90a9208 2025-01-31 Warnings Exact identifier application number: M017 Maximum Strength Blue Emu Pain Relief Blu Emu TROLAMINE SALICYLATE Kingsway Pharmaceuticals dba NFI, LLC 5e02b820-e53a-42cb-abdb-2925617c29ca 2025-01-31 Warnings Exact identifier application number: M017 Sunset Novelties Herquake NUMBING LUBRICANT SUNSET INTIMATES GROUP INC 2ceeca3e-9197-9166-e063-6394a90ae908 2025-01-30 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