FDA.reportPublic FDA data

Premier Value

Product NDC
68016-099
11-digit product format
680160099
Labeler code
68016
Product ID
68016-099_934c7f1b-9cb5-44c0-82c4-c2b85b95af46
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmacy Value Alliance LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1995-08-23
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-099IInactivated by FDA2026-09-14
excluded packagepackage68016-09968016-099-02IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-099-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-099-02f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct 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
68016-099-022025-07-29C16284748780-13b156c62-25e3-fb37-e063-e6dba90a4e07Premier Value ® Hydrocortisone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-099-02Premier Value Hydrocortisone1 in 1 CARTONCREAM13
68016-099-02Premier Value Hydrocortisone28.4 g in 1 TUBECREAM28.43

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
ALOE VERA WHOLEINACTIVE INGREDIENTKIZ4X2EHYXPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
CHAMOMILE FLOWER OILINACTIVE INGREDIENT60F80Z61A9PREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41PREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
CORN OILINACTIVE INGREDIENT8470G57WFMPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4BPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1
WATERINACTIVE INGREDIENT059QF0KO0RPREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-099PREMIER VALUE HYDROCORTISONE (HYDROCORTISONE) CREAM [PHARMACY VALUE ALLIANCE LLC]3Legacy NDC, 2 package rows20180305_480bea74-2bf7-4824-a593-f5ac1f24650f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN480bea74-2bf7-4824-a593-f5ac1f24650f3
106258hydrocortisone 10 MG/ML Topical CreamSCD480bea74-2bf7-4824-a593-f5ac1f24650f3
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY480bea74-2bf7-4824-a593-f5ac1f24650f3
106258hydrocortisone 1 % Topical CreamSY480bea74-2bf7-4824-a593-f5ac1f24650f3
106258hydrocortisone 1 GM per 100 GM Topical CreamSY480bea74-2bf7-4824-a593-f5ac1f24650f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-099-02680160099021 TUBE in 1 CARTON (68016-099-02) > 28.4 g in 1 TUBE1 tube1995-08-230000-00-00NoNoCurrent