FDA.reportPublic FDA data

Hydrocortisone Acetate

Product NDC
51672-2069
11-digit product format
516722069
Labeler code
51672
Product ID
51672-2069_44fe37d6-007d-8b3b-e063-6394a90ac802
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-06-01
Substance
HYDROCORTISONE ACETATE
Active strength
1 g/100g
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
Brand name suffix
Antipruritic (Anti-Itch)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74
Rxcui106258

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51672-2069-22025-12-05C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-92025-12-05C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-22025-01-30C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-92025-01-30C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-22023-03-31C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-92023-03-31C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-22023-01-30C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-92023-01-30C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-22021-02-05C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-92021-02-05C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-22021-01-29C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream
51672-2069-92021-01-29C16284748780-1ba0f9c33-4e98-a910-e053-dadaa90a0b85Hydrocortisone 1% Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2069-2Hydrocortisone Acetate Antipruritic (Anti-Itch)28.4 g in 1 TUBECREAM28.49
51672-2069-2Hydrocortisone Acetate Antipruritic (Anti-Itch)1 in 1 CARTONCREAM19
51672-2069-9Hydrocortisone Acetate Antipruritic (Anti-Itch)454 g in 1 JARCREAM4549

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2069-2GM - Gram51672-20697e58ef83-9ecb-4754-96e5-7ade9b37c59912012-07-24
51672-2069-9GM - Gram51672-206931213726-c91a-4798-8489-fd09c97e611f12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrocortisone AcetateACTIVE INGREDIENT3X7931PO74HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JHYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2069HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 3 package rows20230401_9f0b09e7-6cfd-4fd6-8631-67799edf4e08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN9f0b09e7-6cfd-4fd6-8631-67799edf4e089
106258hydrocortisone 10 MG/ML Topical CreamSCD9f0b09e7-6cfd-4fd6-8631-67799edf4e089
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY9f0b09e7-6cfd-4fd6-8631-67799edf4e089
106258hydrocortisone 1 % Topical CreamSY9f0b09e7-6cfd-4fd6-8631-67799edf4e089
106258hydrocortisone 1 GM per 100 GM Topical CreamSY9f0b09e7-6cfd-4fd6-8631-67799edf4e089

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2069-2516722069021 TUBE in 1 CARTON (51672-2069-2) / 28.4 g in 1 TUBE1 tube2001-06-010000-00-00NoNoCurrent
51672-2069-951672206909454 g in 1 JAR (51672-2069-9) 454 g2001-06-010000-00-00NoNoCurrent