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		2026-10-16

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 140 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OWELL NATURALS Deep Penetrating Pain Relief	MENTHOL	OWELL NATURALS BRAND, LLC	b36eb017-ed8d-476e-994b-22b275e00543	2024-01-02	Warnings	Exact identifier application number: M017
Dibucaine	DIBUCAINE 1%	Trifecta Pharmaceuticals USA LLC	e8a56651-a292-7609-e053-2a95a90a7c36	2024-01-02	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	44d17651-a31b-64ca-e054-00144ff8d46c	2024-01-02	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	e0a13344-5493-eb51-e053-2995a90a8183	2024-01-02	Warnings	Exact identifier application number: M017
Sumifun Knee Relieve Patch	KNEE RELIEVE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e031aa5-edf4-8c9d-e063-6394a90afee3	2024-01-02	Warnings	Exact identifier application number: M017
OKeeffes Healthy Feet	ALLANTOIN, LIDOCAINE	The Gorilla Glue Company/O'Keeffe's Company	d73709db-3932-3c56-e053-2995a90a7d0a	2024-01-01	Warnings	Exact identifier application number: M017
PERSONAL CARE ICE COLD	MENTHOL	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	1994356c-e347-5b7d-e063-6394a90a476c	2024-01-01	Warnings	Exact identifier application number: M017
Dendracin Neurodendraxcin	METHYL SALICYLATE, MENTHOL AND CAPSAICIN	Proficient Rx LP	7e765fc1-74c6-4af3-a9cf-05b57011d7d8	2024-01-01	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Itch Relief Moisturizing	PRAMOXINE HYDROCHLORIDE	L'Oreal USA Products Inc	c6a0880e-fc16-46e9-8314-c56c9d15bf31	2023-12-31	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Anti Itch	HYDROCORTISONE	L'Oreal USA Products Inc.	8d65e945-2557-486f-9279-ecbaa08f31c4	2023-12-31	Warnings	Exact identifier application number: M017
Nighttime Sleep-Aid Non-Habit Forming	DIPHENHYDRAMINE HCI	AptaPharma Inc.	ed0ba7aa-e794-43da-b576-6b9945bf7477	2023-12-30	Warnings	Exact identifier application number: M017
Sting-Kill	BENZOCAINE AND MENTHOL	RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH	b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701	2023-12-29	Warnings	Exact identifier application number: M017
Maybelline New York Baby Lips Dr Rescue Medicated Balm	MENTHOL	L'Oreal USA Products Inc	2f7b8221-66f6-4aed-8359-318cfc656a72	2023-12-28	Warnings	Exact identifier application number: M017
Equate Cortisone	HYDROCORTISONE 1%	Walmart Inc	027fae33-93a0-a61f-e063-6294a90a990f	2023-12-27	Warnings	Exact identifier application number: M017
Walgreens Cool n Heat Lidocaine	LIDOCAINE HCL 4%	Walgreens Co	0681c6c5-5a8b-ea9e-e063-6394a90a83bc	2023-12-27	Warnings	Exact identifier application number: M017
EXTRA STRENGTH WAL-DRYL ITCH RELIEF	DIPHENHYDRAMINE, ZINC ACETATE	WALGREEN CO	681cf1af-2cc3-4e6d-b76f-f00731ea3e12	2023-12-27	Warnings	Exact identifier application number: M017
XRay Pain Relief	MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE	Genomma Lab USA	5244ddee-fd9e-4df3-8fb3-b16aa321a316	2023-12-27	Warnings	Exact identifier application number: M017
Camphor Spirit	CAMPHOR 10%	Pharma Nobis, LLC	e42fbe63-b01c-4f85-e053-2a95a90a5143	2023-12-26	Warnings	Exact identifier application number: M017
Equate Calaspray	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Walmart Inc	027ed5ab-05ec-569f-e063-6394a90abbc3	2023-12-26	Warnings	Exact identifier application number: M017
EXTERNAL ANALGESIC	CAMPHOR, CAPSICUM, MENTHOL	Hmong 21	3b6155a5-51aa-2780-e054-00144ff8d46c	2023-12-26	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