Locoid

Product NDC
16781-392
11-digit product format
167810392
Labeler code
16781
Product ID
16781-392_0f181daf-c06f-4c63-bfa4-823ffddbbfbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE BUTYRATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA022076
Marketing category
NDA
Marketing start
2013-07-03
Marketing end
0000-00-00
Substance
HYDROCORTISONE BUTYRATE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16781-392-02ML - Milliliter16781-39283026ff4-548b-45a1-8e9e-d4faa8ae11b912013-12-02
16781-392-04ML - Milliliter16781-39278f7b6b8-b929-4c37-87ce-4df7b094434e12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE BUTYRATEACTIVE INGREDIENT05RMF7YPWNLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8LOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
CETETH-20INACTIVE INGREDIENTI835H2IHHXLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9ULOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RLOCOID (HYDROCORTISONE BUTYRATE) LOTION [ONSET DERMATOLOGICS, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16781-392LOCOID (HYDROCORTISONE BUTYRATE) LOTION [BAUSCH HEALTH US, LLC]13Legacy NDC20231031_a147236d-be90-47cf-9d88-7ea14d3a8158.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16781-392-02167810392021 BOTTLE in 1 CARTON (16781-392-02) > 59 mL in 1 BOTTLE1 bottle2013-07-030000-00-00NoNoCurrent
16781-392-04167810392041 BOTTLE in 1 CARTON (16781-392-04) > 118 mL in 1 BOTTLE1 bottle2013-07-030000-00-00NoNoCurrent