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 118 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Strength Pain Relief Gel MENTHOL TELEBRANDS CORP d91b2e09-550e-4968-e053-2995a90ae323 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Cream LIDOCAINE 4% Telebrands Corp c3162ba8-ac2d-5a65-e053-2995a90af246 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief LIDOCAINE TELEBRANDS CORP d91ba9b1-083f-32e9-e053-2a95a90a9bd1 2024-11-20 Warnings Exact identifier application number: M017 DynaRub PAIN RELIEVING CREAM Dynarex Corporation 7f853941-a2d7-ed26-e053-2991aa0aa9ee 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions bcdc0322-bc75-4662-9c5a-d1be1d055252 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 604a30c9-2306-47a1-bd31-94b63639dd90 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 0b489420-3b5c-43c5-aab4-0e3720acf9ce 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions dd906129-a787-4352-856d-d7a915031a6e 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Arthritis Pain Relief Cream HISTAMINE DIHYDROCHLORIDE Walgreens Company 80d3031a-7fa9-4f5b-b85e-c7c6ef314801 2024-11-20 Warnings Exact identifier application number: M017 Anti-Itch Medicated Maximum Strength BENZOCAINE AND RESORCINOL Walgreens Company 7fd86dcb-edef-4d0d-b389-7ecea595fe67 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Pain Relief BENZOCAINE Walgreens Company 7cee7234-32cd-4bf3-8a6c-0882585eec7f 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Advanced Scar Gel ADVANCED SCAR GEL Walgreens Company 2c040475-a124-485c-933e-66b452f5ab46 2024-11-20 Warnings Exact identifier application number: M017 LidoPro Pain Relief CAPSAICIN AND LIDOCAINE Clinic Pharma 274611ea-7fc2-ba3f-e063-6294a90aa50f 2024-11-19 Warnings Exact identifier application number: M017 First Aid Only Sting Relief Pad BENZOCAINE Acme United Corporation 5087cbbd-1bbe-62ed-e054-00144ff8d46c 2024-11-19 Warnings Exact identifier application number: M017 Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL Acme United Corporation 6bb9a782-2394-4c8c-e053-2991aa0a08d4 2024-11-19 Warnings Exact identifier application number: M017 First Aid Only Sting Relief BENZOCAINE Acme United Corporation 697127d1-c02e-16d2-e053-2a91aa0a39fd 2024-11-19 Warnings Exact identifier application number: M017 First Aid Only Hydrocortisone 1% Anti-Itch HYDROCORTISONE Acme United Corporation e5597b11-b08e-99e1-e053-2a95a90a15a5 2024-11-19 Warnings Exact identifier application number: M017 Equate Cold Therapy Pain Relieving Roll-on Analgesic MENTHOL, UNSPECIFIED FORM Wal-Mart Stores, Inc. 4115f0ac-e12a-4e59-94f5-a47dcc7f8766 2024-11-18 Warnings Exact identifier application number: M017 Equate Cold Therapy Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM Wal-Mart Stores, Inc. ac6c2112-8692-4628-97d8-3a5a9f509766 2024-11-18 Warnings Exact identifier application number: M017 Equate Odor-Free Therapy Arthritis Analgesic TROLAMINE SALICYLATE Wal-Mart Stores, Inc. 1d73e7b6-c7f9-4680-b3e3-a954b91e1863 2024-11-18 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