Home NDC 76348-804 HEALING TREE CALMING ANTI-ITCH
Product NDC 76348-804
11-digit product format 763480804
Labeler code 76348
Product ID 76348-804_42f25140-568e-2798-e063-6394a90a602f
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Renu Laboratories, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-26
Substance HYDROCORTISONE
Active strength .59 mg/59mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 76348-804-06 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76348-804-06 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76348-804-06 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76348-804-06 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76348-804-06 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76348-804-06 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76348-804-06 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76348-804-06 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 HEALING TREE CALMING ANTI-ITCH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE .59 mg/59mL
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76348-804-05 HEALING TREE CALMING ANTI-ITCH 59 mL in 1 BOTTLE, PLASTIC CREAM 59 3 76348-804-06 HEALING TREE CALMING ANTI-ITCH 1 in 1 BOX CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76348-804 HEALING TREE CALMING ANTI-ITCH (HYDROCORTISONE) CREAM [RENU LABORATORIES, LLC] 2 Current NDC, 2 package rows 20250515_fc8bcde9-26e8-a35f-e053-6394a90a3300.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 148 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Teeter reNEW MUSCLES Pain Relieving METHYL SALICYLATE, MENTHOL STL International INC ebc777b0-d141-4a62-9366-d14787eaefe0 2023-11-10 Warnings Exact identifier application number: M017 FEELGOOD LAB Natural Pain Cream MENTHOL The Feel Good Lab, LLC 799d464c-aaf1-429a-877b-2a692397bb49 2023-11-10 Warnings Exact identifier application number: M017 HIGHER CONTROL Male Climax Control Lubricating BENZOCAINE Product Max Group Inc 5f5fd127-34c5-403a-aa95-c9874ae79492 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f93076-1f68-58e6-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f9622e-27c7-6a5d-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 FEEL GOOD LAB Natural Pain Cream MENTHOL THE FEEL GOOD LAB, LLC 774a72b1-b719-4217-846e-7f9921fd1b16 2023-11-10 Warnings Exact identifier application number: M017 BODY ACTION PRODUCTS Climax Control Gel BENZOCAINE PRODUCT MAX GROUP INC 53e746cc-0078-4381-bf0b-9c8f98d66904 2023-11-10 Warnings Exact identifier application number: M017 BODY ACTION PRODUCTS Endless Love for Men BENZOCAINE PRODUCT MAX GROUP INC d0fa792d-dc04-4bdf-a22d-dea896beae5b 2023-11-10 Warnings Exact identifier application number: M017 Endless Love For Men BENZOCAINE Body Action Products, Inc 4e89cd3a-ecad-44c3-acb3-6d0810add8c0 2023-11-10 Warnings Exact identifier application number: M017 BODY ACTION PRODUCTS Higher Control Male Climax BENZOCAINE PRODUCT MAX GROUP INC 3c7fa73b-abe8-4a8d-951c-4e785d6e812c 2023-11-10 Warnings Exact identifier application number: M017 Uber Numb LIDOCAINE HYDROCHLORIDE UBERScientific, LLC 65a319a6-89d2-44c9-81d5-30327f9948cb 2023-11-10 Warnings Exact identifier application number: M017 Uber Numb LIDOCAINE HYDROCHLORIDE UBERScientific, LLC 768f3f0e-1add-404f-b869-00a9f35ad34a 2023-11-10 Warnings Exact identifier application number: M017 Zcaine Fast Acting Anesthetic LIDOCAINE PHI, Inc d072243f-6ba6-4ab6-8ebf-a2381fa9c2df 2023-11-09 Warnings Exact identifier application number: M017 Plum Smooth Plumb Numb Gelee LIDOCAINE Universal Companies, Inc. 6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e 2023-11-09 Warnings Exact identifier application number: M017 Sonacaine Topical Anesthetic With Menthol LIDOCAINE Filltech USA, LLC ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a 2023-11-09 Warnings Exact identifier application number: M017 Bed Bug Instant Bite Relief LIDOCAINE P.F. Harris Mfg. Co. LLC 7f472fd0-5605-4cc6-b4b2-1267e815255c 2023-11-09 Warnings Exact identifier application number: M017 Valtrum Aerobic Sports SALICYLIC ACID MENTHOL CAMPHOR (NATURAL) LABORATORIOS QUANTIUM LLC 33f2491e-c1f2-4e5a-acbe-8ace844b88d6 2023-11-09 Warnings Exact identifier application number: M017 Valtrum Topical Analgesic Roll On SALICYLIC ACID MENTHOL CAMPHOR (NATURAL) LABORATORIOS QUANTIUM LLC 28167e2a-9afb-44e7-90c7-9577df9504b6 2023-11-09 Warnings Exact identifier application number: M017 Satohap Cool Type CAMPHOR, MENTHOL, METHYL SALICYLATE Sato Pharmaceutical Co., Ltd. fe07a00a-2699-44d3-887d-bd068948ad7b 2023-11-07 Warnings Exact identifier application number: M017 Hims Delay Wipes BENZOCAINE WIPES Hims Inc. adbead3d-dca0-4919-b688-44c88f779e5a 2023-11-07 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 76348-804-05 76348080405 59 mL in 1 BOTTLE, PLASTIC 59 ml Historical 76348-804-06 76348080406 1 in 1 BOX Historical