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		2026-10-15

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 126 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Anti Itch	HYDROCORTISONE	L. Perrigo Company	ecd6d841-40b9-42c9-825d-d172cd04824d	2024-10-03	Warnings	Exact identifier application number: M017
Gold Bond Medicated Original Strength Body	MENTHOL	Navajo Manufacturing Company Inc.	f71d598c-92c3-d6fd-e053-6394a90a97d7	2024-10-03	Warnings	Exact identifier application number: M017
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	9e663535-4acc-4b37-acae-8c17517c5a3d	2024-10-03	Warnings	Exact identifier application number: M017
Topcare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	849c60fc-e455-4c50-8adf-ac59c0ee785b	2024-10-03	Warnings	Exact identifier application number: M017
rexall anti itch maximum strength relief	HYDROCORTISONE	Dolgencorp, LLC	894cf9ab-693a-4210-96df-605947f51b63	2024-10-03	Warnings	Exact identifier application number: M017
equaline anti itch maximum strength	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	070000d7-7d4d-439b-9a91-851ba7c027e6	2024-10-03	Warnings	Exact identifier application number: M017
hydrocortisone anti itch	HYDROCORTISONE	H E B	a1a9fed8-4938-48b5-81f1-d3942d534bb8	2024-10-03	Warnings	Exact identifier application number: M017
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	ef9ea069-9b97-4bf5-aaac-deb85334dbd0	2024-10-03	Warnings	Exact identifier application number: M017
Basic Care Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	7fa13ab4-5f2d-4a48-816f-1b22d5f757b2	2024-10-03	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	dc388dc1-0c4f-4bf1-8a12-fa39892317bc	2024-10-02	Warnings	Exact identifier application number: M017
Geliga Muscular	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	fb2beb08-0ad6-a89d-e053-6294a90aa6fe	2024-10-02	Warnings	Exact identifier application number: M017
Geliga Muscular Balm	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	da28097f-4b5c-6159-e053-2a95a90a7d96	2024-10-02	Warnings	Exact identifier application number: M017
Circatrix	CAPSAICIN	PureTek Corporation	cd3b1256-2df8-dc26-e053-2a95a90ad049	2024-10-02	Warnings	Exact identifier application number: M017
DermacinRx Penetral Cream	CAPSAICIN	PureTek Corporation	1e343a52-6071-3230-e054-00144ff8d46c	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Aromatic	CAMPHOR MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	36abfc2c-d424-4df8-968d-866342c96a56	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Balm	CAMPHOR MENTHOL	Eagle Indo Pharma, PT	87614869-9675-2c76-e053-2a95a90a48a9	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	d9a93daa-4e24-6690-e053-2a95a90a147c	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Extra Strength	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	5e02fbe3-5bc7-430e-b661-3a760ddd8fe0	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Oil Refreshing	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	c62a4313-2c07-5f58-e053-2995a90a083a	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Aromatic	CAMPHOR MENTHOL METHYL SALICYLATE	Eagle Indo Pharma, PT	e272ec90-3cd9-5b70-e053-2a95a90a1df4	2024-10-02	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