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

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
IngredientStrength
HYDROCORTISONE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui106258, 206354

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-117-28DermaCortAnti-itch28 g in 1 TUBECREAM286
54473-117-01DermaCortAnti-Itch28 g in 1 TUBECREAM281

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT1G56KV7BUJDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
STEARETH-2INACTIVE INGREDIENTV56DFE46J5DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
STEARETH-21INACTIVE INGREDIENT53J3F32P58DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-117DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]6Current NDC, Legacy NDC, 1 package rows20250409_24044b0f-dd1e-4762-82b8-7a28b08c2f77.zip
54473-117DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1Current NDC, Legacy NDC, 1 package rows20111122_a0962a88-8a49-414c-aecf-db94ec033f16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206354Dermacort 1 % Topical CreamPSN24044b0f-dd1e-4762-82b8-7a28b08c2f776
106258hydrocortisone 1 % Topical CreamPSN24044b0f-dd1e-4762-82b8-7a28b08c2f776
206354hydrocortisone 10 MG/ML Topical Cream [Dermacort]SBD24044b0f-dd1e-4762-82b8-7a28b08c2f776
106258hydrocortisone 10 MG/ML Topical CreamSCD24044b0f-dd1e-4762-82b8-7a28b08c2f776
206354Dermacort 1 % Topical CreamSY24044b0f-dd1e-4762-82b8-7a28b08c2f776
206354Dermacort 10 MG/ML Topical CreamSY24044b0f-dd1e-4762-82b8-7a28b08c2f776
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY24044b0f-dd1e-4762-82b8-7a28b08c2f776
106258hydrocortisone 1 % Topical CreamSY24044b0f-dd1e-4762-82b8-7a28b08c2f776
106258hydrocortisone 1 GM per 100 GM Topical CreamSY24044b0f-dd1e-4762-82b8-7a28b08c2f776
206354Dermacort 1 % Topical CreamPSNa0962a88-8a49-414c-aecf-db94ec033f161
106258hydrocortisone 1 % Topical CreamPSNa0962a88-8a49-414c-aecf-db94ec033f161
206354hydrocortisone 10 MG/ML Topical Cream [Dermacort]SBDa0962a88-8a49-414c-aecf-db94ec033f161
106258hydrocortisone 10 MG/ML Topical CreamSCDa0962a88-8a49-414c-aecf-db94ec033f161
206354Dermacort 1 % Topical CreamSYa0962a88-8a49-414c-aecf-db94ec033f161
206354Dermacort 10 MG/ML Topical CreamSYa0962a88-8a49-414c-aecf-db94ec033f161
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYa0962a88-8a49-414c-aecf-db94ec033f161
106258hydrocortisone 1 % Topical CreamSYa0962a88-8a49-414c-aecf-db94ec033f161
106258hydrocortisone 1 GM per 100 GM Topical CreamSYa0962a88-8a49-414c-aecf-db94ec033f161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-117-015447301170128 g in 1 TUBE28 gHistorical
54473-117-285447301172828 g in 1 TUBE (54473-117-28) 28 g2018-01-010000-00-00NoNoCurrent