Hydrocortisone Acetate

Product NDC
47832-205
11-digit product format
478320205
Labeler code
47832
Product ID
47832-205_1054b185-9c83-4935-a364-9b6ce657edbc
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Bentlin Products LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-24
Substance
HYDROCORTISONE ACETATE
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
Hydrocortisone Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74
Rxcui1043690

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
47832-205-05Hydrocortisone Acetate576 in 1 CASECREAM5765
47832-205-05Hydrocortisone Acetate5 g in 1 PACKETCREAM55
47832-205-15Hydrocortisone Acetate28 g in 1 TUBECREAM285
47832-205-15Hydrocortisone Acetate1 in 1 CARTONCREAM15
47832-205-34Hydrocortisone Acetate1 in 1 CARTONCREAM15
47832-205-34Hydrocortisone Acetate56 g in 1 TUBECREAM565

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74HYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XHYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IHYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UHYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1HYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3THYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYHYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47832-205HYDROCORTISONE ACETATE CREAM [BENTLIN PRODUCTS LLC]5Current NDC, Legacy NDC, 6 package rows20231031_4346351c-8e11-46ae-b428-98d17f55beb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043690hydrocortisone acetate 1 % Topical CreamPSN4346351c-8e11-46ae-b428-98d17f55beb95
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD4346351c-8e11-46ae-b428-98d17f55beb95
1043690hydrocortisone acetate 1 % Topical CreamSY4346351c-8e11-46ae-b428-98d17f55beb95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47832-205-0547832020505576 PACKET in 1 CASE (47832-205-05) / 5 g in 1 PACKET576 packet2014-12-080000-00-00NoNoCurrent
47832-205-15478320205151 TUBE in 1 CARTON (47832-205-15) / 28 g in 1 TUBE1 tube2018-02-070000-00-00NoNoCurrent
47832-205-34478320205341 TUBE in 1 CARTON (47832-205-34) / 56 g in 1 TUBE1 tube2007-01-240000-00-00NoNoCurrent