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 142 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Pain Relief Roll-On	LIDOCAINE 4%	Humco Holding Group, Inc.	a8be9e46-1616-40a9-e053-2a95a90ac3bc	2023-12-15	Warnings	Exact identifier application number: M017
Hot/Cold Menthol 16% Roll-On	HOT/COLD MENTHOL 16% ROLL-ON	Humco Holding Group, Inc	a8bf9744-9979-13c1-e053-2a95a90a30aa	2023-12-15	Warnings	Exact identifier application number: M017
Freds Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Discount Drug Mart	8697b932-da5a-717e-e053-2a91aa0afcae	2023-12-12	Warnings	Exact identifier application number: M017
CVS Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	CVS	86972218-31fe-6942-e053-2991aa0a8850	2023-12-12	Warnings	Exact identifier application number: M017
Best Choice Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	value merchandisers	869631f8-aa1e-8ea4-e053-2a91aa0a5c57	2023-12-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Weeks & Leo Co., Inc.	0c5325e3-4796-856c-e063-6394a90a1f90	2023-12-12	Warnings	Exact identifier application number: M017
Westlake Anti-itch	HYDROCORTISONE	Westlake Pharma LLC	0c53c982-3f23-a2d5-e063-6394a90acd55	2023-12-12	Warnings	Exact identifier application number: M017
Rite Aid Anti-itch	HYDROCORTISONE	Rite Aid	0c540422-1579-9217-e063-6294a90ad06a	2023-12-12	Warnings	Exact identifier application number: M017
Anti-itch Paraben Free	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c5419c5-0929-7ca6-e063-6294a90ac0a7	2023-12-12	Warnings	Exact identifier application number: M017
Rite Aid Hydrocortisone	HYDROCORTISONE 1%	Rite Aid	0c580f96-7fe9-19df-e063-6394a90a5a22	2023-12-12	Warnings	Exact identifier application number: M017
Anti itch	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c58b750-d3a6-5ed1-e063-6294a90a4321	2023-12-12	Warnings	Exact identifier application number: M017
Greencaine Blast	LIDOCAINE	ALMA Laboratories, Inc.	031e0065-4c8a-43d8-bc69-3efa3c6c0ae3	2023-12-12	Warnings	Exact identifier application number: M017
Ageless Pain Relief	METHYL SALICYLATE, MENTHOL	Isagenix International, LLC	3c7e493b-923d-44b1-9076-46c7894308d4	2023-12-12	Warnings, Adverse reactions	Exact identifier application number: M017
CVS Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	CVS	857af609-9dd7-a07a-e053-2991aa0ab6ba	2023-12-11	Warnings	Exact identifier application number: M017
Rite Aid Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Rite Aid	0c4170dd-e1fa-d549-e063-6394a90a5c23	2023-12-11	Warnings	Exact identifier application number: M017
Westlake Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Westlake HB Pharma LLC	0c416ba6-b01f-0609-e063-6294a90ae2a1	2023-12-11	Warnings	Exact identifier application number: M017
CVS Regular Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	CVS	87473ace-d834-e43f-e053-2a95a90a819c	2023-12-11	Warnings	Exact identifier application number: M017
Katinko External Analgesic Oil	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Greenstone Pharmaceutical Inc.	5881fc35-3293-4f0b-801a-afcd6feb9496	2023-12-08	Warnings	Exact identifier application number: M017
Katinko Pain And Itch Relieving	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Greenstone Pharmaceutical Inc.	fe907fa4-4a01-4974-b71f-9cd980b4eaa2	2023-12-08	Warnings, Adverse reactions	Exact identifier application number: M017
Cycle	MENTHOL	La Mend, Inc.	cfc0bcde-ef91-1e6c-e053-2a95a90ab79e	2023-12-07	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