Dermarest

Product NDC: 63736-339
11-digit product format: 637360339
Labeler code: 63736
Product ID: 63736-339_ee4d2862-849a-43e1-9e1d-e3b275740cad
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: LOTION
Route: TOPICAL
Labeler: Insight Pharmaceuticals LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-09-20
Substance: HYDROCORTISONE
Active strength: 10 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Dermarest
Brand name suffix: Eczema Medicated
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	10 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
103403	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
0292ab62-5088-45fa-a056-70c2fcc19ef7	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63736-339-24	DermarestEczema Medicated	24 in 1 CASE	LOTION	24		7
63736-339-24	DermarestEczema Medicated	1 in 1 CARTON	LOTION	1		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Green Tea Leaf	INACTIVE INGREDIENT	W2ZU1RY8B0	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Panthenol	INACTIVE INGREDIENT	WV9CM0O67Z	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
PEG-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Safflower	INACTIVE INGREDIENT	4VBL71TY4Y	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63736-339	DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS LLC]	7	Current NDC, Legacy NDC, 2 package rows	20241105_0292ab62-5088-45fa-a056-70c2fcc19ef7.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 121 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra-Strength Pain Relief Analgesic	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	TARGET CORPORATION	159c5a84-bf68-41dd-a2d3-bc2402037244	2024-10-30	Warnings	Exact identifier application number: M017
DG Health Cold n Hot Pain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Dolgencorp Inc	8fe13b85-ab74-42f8-a664-d3d2959921ac	2024-10-30	Warnings	Exact identifier application number: M017
DEBACHERE Butt Balm After Care Antiseptic Pain Relief	BENZOCAINE, BENZALKONIUM CHLORIDE	DE.BACHERE USA LLC	8ba42864-69bf-455c-98d4-7f4ff94edceb	2024-10-29	Warnings	Exact identifier application number: M017
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	beefab66-b056-4bf1-b047-0780704ab87e	2024-10-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	H E B	15eb4676-5f6e-4c28-b5b9-4e45412dc37a	2024-10-29	Warnings	Exact identifier application number: M017
Rael PAIN RELIEF ROLL-ON Analgesic	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Rael, Inc.	e6c49606-7c13-4dc6-a22d-ba54173ba788	2024-10-28	Warnings	Exact identifier application number: M017
Monistat Care Instant Itch Relief	BENZOCAINE	Insight Pharmaceuticals LLC	4e9dc791-419f-4c79-aed4-760f8c17a5dd	2024-10-25	Warnings	Exact identifier application number: M017
ZYLOTROL PAIN RELIEVING	LIDOCAINE HCL, MENTHOL	Asclemed USA, Inc.	1553351c-aee8-4c40-9548-35cce246bda9	2024-10-25	Warnings	Exact identifier application number: M017
Outgro	BENZOCAINE	Medtech Products Inc.	d6be8a1d-aca7-42b1-86da-881d42ffe8d5	2024-10-25	Warnings	Exact identifier application number: M017
Monistat Complete Care Instant Itch Relief	HYDROCORTISONE	Insight Pharmaceuticals LLC	a0f40504-6183-4f32-8d17-6586b3f386a6	2024-10-25	Warnings	Exact identifier application number: M017
Boil Ease	BENZOCAINE	Insight Pharmaceuticals LLC	bf108934-5e1a-4059-9dcf-008f52a83fab	2024-10-25	Warnings	Exact identifier application number: M017
Dermarest Eczema Medicated	HYDROCORTISONE	Insight Pharmaceuticals LLC	0292ab62-5088-45fa-a056-70c2fcc19ef7	2024-10-25	Warnings	Exact identifier application number: M017 ndc (product): 63736-339
anti itch	HYDROCORTISONE	Meijer, Inc.	2db7bcab-acb8-48ad-8cd1-842ff7765ed9	2024-10-23	Warnings	Exact identifier application number: M017
NATUREANCE MIRACLE	MENTHOL	EROS GLOBAL CORP	ec1a2a1f-a38d-9c59-e053-2a95a90ad268	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Plantar Relief Strips	CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	65e142d8-da21-4c55-9faf-b387cb6c2c0e	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	cc011b79-2761-40f7-8142-88f8e30a179a	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Profoot, Inc.	06f82bde-41a1-35f6-e063-6394a90a6437	2024-10-23	Warnings	Exact identifier application number: M017
Deep Cover Bug Bite Relief	BENZOCAINE	Morrisons Outdoors, LLC	25010dd6-fb48-8ee7-e063-6394a90aee6c	2024-10-21	Warnings	Exact identifier application number: M017
Evel Knievels Natural Choice Pain Relief	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	4576656c-4b6e-6965-7665-6c52756c6573	2024-10-21	Warnings	Exact identifier application number: M017
berkley and jensen anti itch	HYDROCORTISONE	BJWC	5cc6e4f6-c62d-4923-9726-9dbc569a3f49	2024-10-19	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
103403	hydrocortisone 1 % Topical Lotion	PSN	0292ab62-5088-45fa-a056-70c2fcc19ef7	7
103403	hydrocortisone 10 MG/ML Topical Lotion	SCD	0292ab62-5088-45fa-a056-70c2fcc19ef7	7
103403	hydrocortisone 1 % Topical Lotion	SY	0292ab62-5088-45fa-a056-70c2fcc19ef7	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63736-339-24	63736033924	24 CARTON in 1 CASE (63736-339-24) / 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE	24 carton	2010-09-20	0000-00-00	No	No	Current