Home NDC 51672-5335-2 Hydrocortisone
Product NDC 51672-5335
Requested package NDC 51672-5335-2
11-digit product format 516725335
Labeler code 51672
Product ID 51672-5335_5933787d-8cc1-5959-e063-6394a90a9f80
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone Cream 1/2%
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-31
Substance HYDROCORTISONE
Active strength .5 g/100g
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
Brand name suffix with Aloe
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE .5 g/100g
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 198707 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 53 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Frankincense and Myrrh Arthritis Pain Therapy MENTHOL Wise Consumer Products 2410a199-f4a3-da6c-e063-6394a90aaace 2025-12-17 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE, MENTHOL Vive Health LLC 462d3b24-643e-91da-e063-6394a90a0e1d 2025-12-17 Warnings Exact identifier application number: M017 Teevodar Pain Relieving MENTHOL Sod-e Biotech Ltd 205b0fef-4f00-db2e-e063-6294a90a93b8 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Arthritis Pain Relief MENTHOL WISE CONSUMER PRODUCTS CO. 116045df-891b-f370-e063-6294a90abe42 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Intensive Foot Therapy MENTHOL Wise Consumer Products 23e56c6b-0f2b-721f-e063-6394a90a1ed0 2025-12-17 Warnings Exact identifier application number: M017 Tiger Balm Ultra Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f0561804-e0f7-495d-9768-9b86a208c51e 2025-12-17 Warnings Exact identifier application number: M017 Kwan Loong METHYL SALICYLATE AND MENTHOL Haw Par Healthcare Ltd. 54bcb26e-786a-403e-9330-11ae9e3c013a 2025-12-17 Warnings Exact identifier application number: M017 Magsoothium Body Cooling Formula MENTHOL Ubu/Elements, Inc. f7fb6ac9-a920-a440-e053-6394a90aaa35 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body Lavender MENTHOL Ubu/Elements, Inc. f9b87fbe-b889-67a1-e053-6394a90acbcd 2025-12-16 Warnings Exact identifier application number: M017 Aquaphor Itch Relief HYDROCORTISONE Beiersdorf Inc b1d0333f-ba60-35d8-e053-2995a90af932 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body MENTHOL Ubu/Elements, Inc. 00b2ef34-42d7-523c-e063-6294a90a753d 2025-12-16 Warnings Exact identifier application number: M017 GENTLECARE HAND AND SKIN SANITIZER BENZALKONIUM CHLORIDE PARAGON SOLUTIONS US, INC. 16650277-fa62-485e-9a82-7763d2b50168 2025-12-16 Warnings Exact identifier application number: M017 Welly First Aid Kit Refill HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE Dongguan Shenglian Tins Products Co., Ltd. 4bc93855-4009-4b49-9fb4-e5864054153d 2025-12-16 Warnings Exact identifier application number: M017 LidocainePain pain reliving gel-patch PAIN RELIVING GEL-PATCH Shenzhen Yuetai Electronic Commerce Co., Ltd 461ebbdd-0f26-a333-e063-6394a90a7a3e 2025-12-16 Warnings Exact identifier application number: M017 Zestama CAPSAICIN V2 Pharma LLC c9b46759-b8df-4ff4-815e-8e032c2635c0 2025-12-15 Warnings Exact identifier application number: M017 equate hydrocortisone HYDROCORTISONE Wal-Mart Stores Inc 70f4636d-4137-498b-ab81-0330de883e53 2025-12-15 Warnings Exact identifier application number: M017 SALONPAS-HOT CAPSICUM CAPSAICIN Hisamitsu Pharmaceutical Co., Inc. ef5373aa-9857-4d01-95af-2d7716e54ae4 2025-12-15 Warnings Exact identifier application number: M017 First Aid Burn Cream FIRST AID BURN CREAM ProStat First Aid LLC f70a442e-7ba7-4860-e053-6394a90ac2bd 2025-12-15 Warnings Exact identifier application number: M017 Burn Ease, 3.5g BURN EASE, 3.5G ProStat First Aid LLC 004aa18f-3a97-f454-e063-6394a90afcff 2025-12-15 Warnings Exact identifier application number: M017 PS-3866 Burn Ease, 0.9g PS-3866 BURN EASE, 0.9G ProStat First Aid LLC 004d00a5-9cff-29ff-e063-6294a90aeb8c 2025-12-15 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51672-5335-2 51672533502 1 TUBE in 1 CARTON (51672-5335-2) / 28.4 g in 1 TUBE 1 tube 2026-07-31 No No Current