DermaCort

Product NDC: 54473-117
11-digit product format: 544730117
Labeler code: 54473
Product ID: 54473-117_30cddb97-469e-d4b1-e063-6394a90a098b
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Melaleuca, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2000-08-02
Substance: HYDROCORTISONE
Active strength: 10 mg/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54473-117		I	Inactivated by FDA		2026-08-11
excluded package	package	54473-117	54473-117-01	I	Inactivated by FDA		2026-08-11

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 2 · 64 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 product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54473-117-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54473-117-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
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 product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-117-28	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-117-01	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 product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-117-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-117-01	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 product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-117-28	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-117-01	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 product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-117-28	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-117-01	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 product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-117-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-117-28	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 product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-117-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-117-28	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 product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-117-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-117-28	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54473-117-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54473-117-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54473-117-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54473-117-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54473-117-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54473-117-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54473-117-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54473-117-28	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54473-117-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54473-117-28	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54473-117-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54473-117-28	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54473-117-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54473-117-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`

Additional Listing Data#

Finished product: Yes
Brand name base: DermaCort
Brand name suffix: Anti-itch
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	10 mg/g

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106258	Internal RxNorm lookup
206354	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
24044b0f-dd1e-4762-82b8-7a28b08c2f77	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
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#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
54473-117-28	2025-04-07	9d75b9cf-f9aa-f424-e053-dadaa90a57ce	DermaCort
54473-117-28	2025-01-30	9d75b9cf-f9aa-f424-e053-dadaa90a57ce	DermaCort
54473-117-28	2023-05-22	9d75b9cf-f9aa-f424-e053-dadaa90a57ce	DermaCort
54473-117-28	2022-01-28	9d75b9cf-f9aa-f424-e053-dadaa90a57ce	DermaCort
54473-117-28	2020-03-19	9d75b9cf-f9aa-f424-e053-dadaa90a57ce	DermaCort
54473-117-28	2020-01-31	9d75b9cf-f9aa-f424-e053-dadaa90a57ce	DermaCort
54473-117-01	2019-11-13	97449f38-bf78-f6ea-e053-dbdaa90aa703	Dermacort Anti-Itch Cream content of label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-117-28	DermaCortAnti-itch	28 g in 1 TUBE	CREAM	28		6
54473-117-01	DermaCortAnti-Itch	28 g in 1 TUBE	CREAM	28		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	1G56KV7BUJ	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
POLYOXYL 100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
STEARETH-2	INACTIVE INGREDIENT	V56DFE46J5	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
STEARETH-21	INACTIVE INGREDIENT	53J3F32P58	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-117	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20250409_24044b0f-dd1e-4762-82b8-7a28b08c2f77.zip
54473-117	DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]	1	Current NDC, Legacy NDC, 1 package rows	20111122_a0962a88-8a49-414c-aecf-db94ec033f16.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 1 of 154 · 3,068 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Cardinal Health, 110 dba Leader	3ed7b8a1-012f-459d-878c-813b93d4673c	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M017
Gel Cooling Pain Relief	MENTHOL	The Kroger Co.	6fb0acc8-8dab-452c-b09e-de97306e1c32	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M017
Lidocaine Tattoo Wipe	LIDOCAINE HYDROCHLORIDE	MD Tattoo Company	369c1d16-597c-e1dc-e063-6394a90a3104	2026-08-06	Warnings	Exact identifier application number: M017
Point Relief Coldspot Pain Relieving	MENTHOL	Fabrication Enterprises Inc	479fb728-4aeb-42e3-b238-f04255514baa	2026-08-05	Warnings	Exact identifier application number: M017
Lidocaine HCl	LIDOCAINE HCL	Topco Associates LLC	584e1f35-4d99-9c85-e063-6294a90ab3d0	2026-08-05	Warnings, Adverse reactions	Exact identifier application number: M017
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	56e36592-a935-61d4-e063-6294a90a6e4c	2026-08-04	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Menthol Pain Relief	MENTHOL	Carlin Consumer Health LLC	584f5c6e-3385-3221-e063-6294a90aabae	2026-08-04	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	2026-08-04	Warnings	Exact identifier application number: M017
procure	HYDROCORTISONE ACETATE	TWIN MED, LLC	2670c9c4-66ad-40e8-a08a-582b160de39d	2026-08-03	Warnings	Exact identifier application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On	MENTHOL	Chattem, Inc.	aa40c907-eeb5-4fda-b35e-439cbecc178c	2026-07-31	Warnings	Exact identifier application number: M017
Alphamale Delay Cream	BENZOCAINE	Prodigy Media Inc	53d682ee-0802-a16d-e063-6394a90aeee1	2026-07-31	Warnings	Exact identifier application number: M017
Pure Primal Delay Cream	BENZOCAINE	Prodigy Media Inc	57e9e894-c14f-d806-e063-6394a90ab8e5	2026-07-31	Warnings	Exact identifier application number: M017
Satohap	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	df0e2b83-8f61-4ed8-bcc4-55e4ea782090	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	cb000134-92a4-4304-8ef0-0347190e1414	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic Hot	CAPSAICIN	Sato Pharmaceutical Co., Ltd.	16b47cb5-ea5f-4514-9a89-141ee4cc60f8	2026-07-31	Warnings	Exact identifier application number: M017
Satohap Cool and Hot Pads	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceutical Co., Ltd.	b6bf1eab-4ab9-f500-e053-2995a90a8d7b	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
SATOHAP COOL and HOT	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceuticals Co., Ltd.	232a4c76-1a0c-2f4b-e063-6394a90a8849	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	2026-07-30	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
206354	Dermacort 1 % Topical Cream	PSN	24044b0f-dd1e-4762-82b8-7a28b08c2f77	6
106258	hydrocortisone 1 % Topical Cream	PSN	24044b0f-dd1e-4762-82b8-7a28b08c2f77	6
206354	hydrocortisone 10 MG/ML Topical Cream [Dermacort]	SBD	24044b0f-dd1e-4762-82b8-7a28b08c2f77	6
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	24044b0f-dd1e-4762-82b8-7a28b08c2f77	6
206354	Dermacort 1 % Topical Cream	SY	24044b0f-dd1e-4762-82b8-7a28b08c2f77	6
206354	Dermacort 10 MG/ML Topical Cream	SY	24044b0f-dd1e-4762-82b8-7a28b08c2f77	6
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	24044b0f-dd1e-4762-82b8-7a28b08c2f77	6
106258	hydrocortisone 1 % Topical Cream	SY	24044b0f-dd1e-4762-82b8-7a28b08c2f77	6
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	24044b0f-dd1e-4762-82b8-7a28b08c2f77	6
206354	Dermacort 1 % Topical Cream	PSN	a0962a88-8a49-414c-aecf-db94ec033f16	1
106258	hydrocortisone 1 % Topical Cream	PSN	a0962a88-8a49-414c-aecf-db94ec033f16	1
206354	hydrocortisone 10 MG/ML Topical Cream [Dermacort]	SBD	a0962a88-8a49-414c-aecf-db94ec033f16	1
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	a0962a88-8a49-414c-aecf-db94ec033f16	1
206354	Dermacort 1 % Topical Cream	SY	a0962a88-8a49-414c-aecf-db94ec033f16	1
206354	Dermacort 10 MG/ML Topical Cream	SY	a0962a88-8a49-414c-aecf-db94ec033f16	1
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	a0962a88-8a49-414c-aecf-db94ec033f16	1
106258	hydrocortisone 1 % Topical Cream	SY	a0962a88-8a49-414c-aecf-db94ec033f16	1
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	a0962a88-8a49-414c-aecf-db94ec033f16	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54473-117-01	54473011701	28 g in 1 TUBE	28 g					Historical
54473-117-28	54473011728	28 g in 1 TUBE (54473-117-28)	28 g	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DermaCort	Melaleuca, Inc.	2025-03-20	HUMAN OTC DRUG LABEL	6
Dermacort Anti-Itch Cream content of label	Melaleuca, Inc.	2011-11-09	HUMAN OTC DRUG LABEL	1