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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	76348-804	76348-804-06	D	Discontinued by firm		2026-10-05

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fc8bcde9-26e8-a35f-e053-6394a90a3300	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-05-14	HEALING TREE CALMING ANTI-ITCH CREAM
2025-05-14	HEALING TREE CALMING ANTI-ITCH CREAM
2025-01-30	HEALING TREE CALMING ANTI-ITCH CREAM
2025-01-30	HEALING TREE CALMING ANTI-ITCH CREAM

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 9 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DERMFREE PAIN RELIEF	ARNICA MONTANA HPUS 7% PAIN RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4bb74112-c4e7-7988-e063-6394a90ae3f1	2026-07-24	Warnings	Exact identifier application number: M017
SERYNTH HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4c667f3d-1238-2f02-e063-6394a90ab742	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4ca7222b-d754-9861-e063-6294a90a1b7b	2026-07-24	Warnings	Exact identifier application number: M017
REINREUDE BACK PAIN THERAPY	CAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPY	Jiangxi Yudexi Pharmaceutical Co., LTD	4ca7d0ca-6407-1fed-e063-6394a90aaccc	2026-07-24	Warnings	Exact identifier application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AID	NICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AID	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5821f9-605e-5391-e063-6294a90afcd2	2026-07-24	Warnings	Exact identifier application number: M017
REINREUDE BACK PAIN THERAPY	CAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPY	Jiangxi Yudexi Pharmaceutical Co., LTD	4dfc77bb-11dd-e0f0-e063-6294a90a4e9c	2026-07-24	Warnings	Exact identifier application number: M017
DRAVYNOR QUIT SMOKING Patches	NICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHES	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5768631f-d517-5b43-e063-6294a90a8f46	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE NUMBING	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5b47ce-2bf1-42c7-e063-6294a90af09f	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE WART CORN REMOVER	SALICYLIC ACID 40% WART CORN REMOVER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5c63b3-44de-8736-e063-6394a90ac21a	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE Anti-itch	HYDROCORTISONE1% ANTI-ITCH	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5af4c6-555a-e74c-e063-6394a90aa6ce	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5d0e79-d620-0147-e063-6294a90a3103	2026-07-23	Warnings	Exact identifier application number: M017
MAG 5 PT WARMING FORMULA	MENTHOL	RENU LABORATORIES, LLC	a499ac9b-0e8e-e23f-e053-2a95a90abe9a	2026-07-23	Warnings	Exact identifier application number: M017
Icy Hot Performance Cream Pain Relief	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	73f7a113-ef11-4932-bf4d-4e62863f7941	2026-07-23	Warnings	Exact identifier application number: M017
Numbing Pain Relief	LIDOCAINE 4%	Walgreen Company	2425badb-e196-e9f8-e063-6294a90a7bf4	2026-07-22	Warnings	Exact identifier application number: M017
Cooling Pain Relief	MENTHOL 4.5%	Walgreen Company	24345ccf-c96f-31b0-e063-6294a90a82b5	2026-07-22	Warnings	Exact identifier application number: M017
Heat Pain Relief	CAPSAICIN 0.1%	Walgreen Company	2434f9cf-74aa-17af-e063-6294a90a56d9	2026-07-22	Warnings	Exact identifier application number: M017
Pain Relief Patch Lidocaine	LIDOCAINE	HyVee	41c26a66-3371-2c2c-e063-6294a90aa38b	2026-07-22	Warnings	Exact identifier application number: M017
CVS Ultra Strength Muscle	MENTHOL, CAMPHOR, METHYL SALICYLATE	CVS Pharmacy	48bef8bc-6e39-a328-e063-6394a90ae450	2026-07-22	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	AKRON PHARMA INC	daad9a1e-98d2-4ce7-9d97-ac5d81905abb	2026-07-22	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving	MENTHOL, CAMPHOR	Active and Innovative	573c2d85-9e0b-7955-e063-6394a90aff64	2026-07-22	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

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