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 71 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Signature Care Cold and Hot MENTHOL, AND METHYL SALICYLATE Safeway Inc. ab201023-e3dc-52ec-e053-2995a90a1f18 2025-10-24 Warnings Exact identifier application number: M017 HealthWise Medicated Cold Hot 5% Patch MENTHOL Veridian Healthcare 15aef56f-cd25-05ac-e063-6394a90a07bb 2025-10-23 Warnings Exact identifier application number: M017 Alivio LIDOCAINE Amerise Pharmaceuticals LLC eb3a98f1-c875-4f08-8b4b-44e22626b609 2025-10-23 Warnings Exact identifier application number: M017 Pain Relieveing Gel-Patch LIDOCAINE Bullet point LLC 41d507c4-ad37-2686-e063-6394a90aae5b 2025-10-23 Warnings Exact identifier application number: M017 ActivICE MENTHOL Medline Industries, LP 98fa9a34-0e1e-0997-e053-2a95a90ac77d 2025-10-23 Warnings Exact identifier application number: M017 Coralite Pain Relief Hot MENTHOL AND CAPSAICIN United Exchange Corporation 78eb133d-01bb-6466-e053-2991aa0accc0 2025-10-23 Warnings Exact identifier application number: M017 Americaine BENZOCAINE Insight Pharmaceuticals LLC 4fd14452-0285-40c4-b835-36935c2056b2 2025-10-23 Warnings Exact identifier application number: M017 zourunan PAIN RELIEF PAIN RELIEF Guchutang Biotechnology (Longyan) Co., Ltd 41bc1c0c-63d5-0d41-e063-6394a90a341b 2025-10-22 Warnings Exact identifier application number: M017 zourunan PAIN RELIEF PAIN RELIEF Guchutang Biotechnology (Longyan) Co., Ltd 41bd0769-6ba0-d0d5-e063-6294a90af7c9 2025-10-22 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Knee MENTHOL United Exchange Corp. aa5873bd-af64-41cc-8f16-7714c56bca96 2025-10-22 Warnings Exact identifier application number: M017 Family Care Muscle Rub CAMPHOR, MENTHOL, AND METHYL SALICYLATE United Exchange Corp. 63006bb5-76e8-eb64-e053-2991aa0a95ad 2025-10-22 Warnings Exact identifier application number: M017 Winco Cold and Hot Medicated Patch Large MENTHOL WINCO FOODS, LLC af0d86c4-f74e-2dbe-e053-2a95a90a74c1 2025-10-22 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 064a6149-a0e2-8a73-e063-6394a90a7953 2025-10-22 Warnings Exact identifier application number: M017 Topical Analgesic MENTHOL Youngevity International Inc. b4693947-f5b3-6fd3-e053-2995a90ab581 2025-10-22 Warnings Exact identifier application number: M017 PAIN RELIEVING LIDOCAINE Medhome Pharma Inc 41cb1135-84e0-0c9a-e063-6294a90ada96 2025-10-22 Warnings Exact identifier application number: M017 KINKAN AMMONIA, CAMPHOR (NATURAL), MENTHOL KINKANDO CO., LTD . f2c0f3e1-792b-4798-bf6d-acd1bbefa261 2025-10-21 Warnings Exact identifier application number: M017 Coralite Muscle and Joint Pain Relief CAPSACIN United Exchange Corp. ba9a3d72-db7a-4dd0-9220-f43c9ed87114 2025-10-21 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Wrist MENTHOL United Exchange Corp. ae314478-b8ab-4e90-bd0a-7a882d5c1b2e 2025-10-21 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 85bd7658-e951-7daf-e053-2a91aa0a9f54 2025-10-21 Warnings Exact identifier application number: M017 Family Care Maximum Strength Medicated Anti Itch MENTHOL United Exchange Corp. 430b5753-3087-4cb1-bf54-0eedc3f4b1d5 2025-10-21 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