FDA.reportPublic FDA data

HYDROCORTISONE

Product NDC
0168-0014
11-digit product format
001680014
Labeler code
0168
Product ID
0168-0014_c93b88e1-c15b-42ba-a8fb-7bbc37cdc0bb
Type
HUMAN OTC DRUG
Nonproprietary name
HYDROCORTISONE
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
part348
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1968-01-01
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
5 mg/g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct0168-0014DDiscontinued by firm2026-08-17
excluded packagepackage0168-00140168-0014-31DDiscontinued by firm2026-08-17

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0168-0014-31DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0168-0014-31DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0168-0014-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0168-0014-31DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0168-0014-31DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0168-0014-31DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0168-0014-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0168-0014-31DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0168-0014-31DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0168-0014-31DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0168-0014-31DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0168-0014-31DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0168-0014-31IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0168-0014-31IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0168-0014-31IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0168-0014-31EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0014-312022-03-25C16284748780-19d75b9d0-13cc-f424-e053-dadaa90a57ceHYDROCORTISONE CREAM USP, 0.5%
0168-0014-312020-01-31C16284748780-19d75b9d0-13cc-f424-e053-dadaa90a57ceHYDROCORTISONE CREAM USP, 0.5%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0014-31GM - Gram0168-00144f690f63-4539-49de-b89f-5f948f97297812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
lactic acidINACTIVE INGREDIENT33X04XA5ATHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZEHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1