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 92 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HealthWise Ultra OTC Strength Pain Relief Cream	CAMPHOR, MENTHOL, AND METHYL SALICYLATE	Veridian Healthcare	36c3bbf9-a559-4c0d-e063-6394a90a8a1a	2025-06-04	Warnings	Exact identifier application number: M017
Everlight Survival Sting Relief Pad	BENZOCAINE	Yiwu Ori-Power Medtech Co.,Ltd.	364c9882-339e-fe22-e063-6294a90a37f4	2025-06-04	Warnings	Exact identifier application number: M017
LIGHTS Sting Relief Prep Pad	BENZOCAINE	Lights Medical Manufacture Co., Ltd.	4f4d7758-be62-4304-8871-087a90497fa5	2025-06-04	Warnings	Exact identifier application number: M017
Elsophie Nicotine Patches Quit	NICOTINE PATCHES QUIT SMOKING	Shenzhen Xinxin Yunhai Technology Co., Ltd.	36b63da9-94cc-b52a-e063-6394a90a5029	2025-06-03	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	J&A Digital Inc.	d4b09055-b93e-466f-9e24-cae098af6e24	2025-06-02	Warnings	Exact identifier application number: M017
RE-LEVE	MENTHOL	SOMBRA COSMETICS INC.	b4b39d79-0439-41e7-adca-e5ccb8f44e40	2025-05-29	Warnings	Exact identifier application number: M017
PAIN NO MORE THERAPY	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	f7bacc8e-6a8b-4cd8-bd0e-68890bee5818	2025-05-29	Warnings	Exact identifier application number: M017
DermaD ANTI-ITCH Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	8f4a57cb-0a5b-42b0-a325-1f92f3942ad9	2025-05-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	f7aecfb4-c194-4554-8d05-4e46005e654b	2025-05-27	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Nantong Health & Beyond Hygienic Products Inc.	b679ed7b-9d88-4eff-9743-567affe0fe2b	2025-05-27	Warnings	Exact identifier application number: M017
RockSauce Warming Massage Roll On	MENTHOL, METHYL SALICYLATE	Nantong Health & Beyond Hygienic Products Inc.	28eb8273-5789-4f33-bbbe-3a5ec7bc7929	2025-05-27	Warnings	Exact identifier application number: M017
AUVON Pain Relief Cream	LIDOCAINE	SHENZHEN YUWEN E-COMMERCE CO., LTD.	358c2632-3b90-1c54-e063-6294a90ad461	2025-05-22	Warnings	Exact identifier application number: M017
WelAhead by Welmate Lidocaine 5% Roll-on	LIDOCAINE 5%	OTC PHARM LLC	0b75e83e-8c7b-6247-e063-6294a90ac413	2025-05-21	Warnings	Exact identifier application number: M017
Bliss Republic	LIDOCAINE NUMBING EXTRA STRENGTH CREAM	Sargass Group Limited Liability Company	35aba13a-95e6-a395-e063-6294a90a5bdc	2025-05-21	Warnings	Exact identifier application number: M017
Xpect Stopain Clinical	MENTHOL	Cintas Corporation	e911478f-7153-4700-b945-92ec54972f45	2025-05-21	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Preferred Pharmaceuticals Inc.	0976a898-8d79-4b85-b473-c8ad32b4fd00	2025-05-20	Warnings	Exact identifier application number: M017
Numbing Cream	LIDOCAINE	100 KARMA INC	359884d6-188a-e503-e063-6294a90acab4	2025-05-20	Warnings	Exact identifier application number: M017
AY BENDITO - THERMOACTIVE	CAMPHOR, MENTHOL	AY BENDITO - THERMOACTIVE LOTION	835abc66-680f-be06-e053-2a91aa0a309e	2025-05-19	Warnings	Exact identifier application number: M017
Numbing Cream	LIDOCAINE	100 KARMA INC	35884644-d017-eda3-e063-6394a90a1f6c	2025-05-19	Warnings	Exact identifier application number: M017
QUIT SMOKING Proven Patches	NICOTINE	Jiashen International Trade Limited	35570155-c769-dc4c-e063-6394a90a019d	2025-05-17	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