Hydrocortisone

Product NDC
56104-250
11-digit product format
561040250
Labeler code
56104
Product ID
56104-250_422b3418-94ea-ea94-e063-6294a90ac334
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone Continuous Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Premier Brands of America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-20
Substance
HYDROCORTISONE
Active strength
1.13 g/113g
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
Hydrocortisone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1.13 g/113g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui317564

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-250-00Hydrocortisone113 g in 1 CANAEROSOL, SPRAY1134

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-250HYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA, INC.]3Current NDC, Legacy NDC, 1 package rows20241017_d344f68b-9b62-3029-e053-2995a90a1665.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317564hydrocortisone 1 % Topical SprayPSNd344f68b-9b62-3029-e053-2995a90a16654
317564hydrocortisone 10 MG/ML Topical SpraySCDd344f68b-9b62-3029-e053-2995a90a16654
317564hydrocortisone 1 % Topical SpraySYd344f68b-9b62-3029-e053-2995a90a16654

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-250-0056104025000113 g in 1 CAN (56104-250-00) 113 g2021-12-200000-00-00NoNoCurrent