FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3X7931PO74Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043690Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4346351c-8e11-46ae-b428-98d17f55beb9Available on FDA.report

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsExact identifier
application number: M017
Point Relief Coldspot Pain RelievingMENTHOLFabrication Enterprises Inc479fb728-4aeb-42e3-b238-f04255514baa2026-08-05WarningsExact identifier
application number: M017
Lidocaine HClLIDOCAINE HCLTopco Associates LLC584e1f35-4d99-9c85-e063-6294a90ab3d02026-08-05Warnings, Adverse reactionsExact identifier
application number: M017
tuiwaro LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.56e36592-a935-61d4-e063-6294a90a6e4c2026-08-04WarningsExact identifier
application number: M017
Mineral Ice Extreme Menthol Pain ReliefMENTHOLCarlin Consumer Health LLC584f5c6e-3385-3221-e063-6294a90aabae2026-08-04WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack484fe5e4-a058-49c0-a382-c8fc3e20c3b22026-08-04WarningsExact identifier
application number: M017
procureHYDROCORTISONE ACETATETWIN MED, LLC2670c9c4-66ad-40e8-a08a-582b160de39d2026-08-03WarningsExact identifier
application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
application number: M017
Alphamale Delay CreamBENZOCAINEProdigy Media Inc53d682ee-0802-a16d-e063-6394a90aeee12026-07-31WarningsExact identifier
application number: M017
Pure Primal Delay CreamBENZOCAINEProdigy Media Inc57e9e894-c14f-d806-e063-6394a90ab8e52026-07-31WarningsExact identifier
application number: M017
SatohapDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.df0e2b83-8f61-4ed8-bcc4-55e4ea7820902026-07-31WarningsExact identifier
application number: M017
SatogesicDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.cb000134-92a4-4304-8ef0-0347190e14142026-07-31WarningsExact identifier
application number: M017
Satogesic HotCAPSAICINSato Pharmaceutical Co., Ltd.16b47cb5-ea5f-4514-9a89-141ee4cc60f82026-07-31WarningsExact identifier
application number: M017
Satohap Cool and Hot PadsCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceutical Co., Ltd.b6bf1eab-4ab9-f500-e053-2995a90a8d7b2026-07-31Warnings, Adverse reactionsExact identifier
application number: M017
SATOHAP COOL and HOTCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceuticals Co., Ltd.232a4c76-1a0c-2f4b-e063-6394a90a88492026-07-31Warnings, Adverse reactionsExact identifier
application number: M017
Cortizone 10 Itch Relief Massaging RollerballHYDROCORTISONEChattem, Inc.1e27682c-f856-41f1-9935-37540960a4c72026-07-31WarningsExact identifier
application number: M017
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsExact identifier
application number: M017
ACOLYE Lidocaine Cream Topical Analgesia CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd57deebf7-52f1-4256-e063-6294a90a75d52026-07-30WarningsExact identifier
application number: M017

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