FDA.reportPublic FDA data

Cortaid Maximum Strength

Product NDC
0187-5521
11-digit product format
001875521
Labeler code
0187
Product ID
0187-5521_67fd0902-44eb-40b8-8743-de7d691533cd
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-10-01
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 productproduct0187-5521DDiscontinued by firm2026-08-03
excluded packagepackage0187-55210187-5521-01DDiscontinued by firm2026-08-03

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 · 26 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued 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 packagepackage0187-5521-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0187-5521-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-05-10CORTAID Maximum Strength Cream
2020-09-27CORTAID Maximum Strength Cream
2020-09-25CORTAID Maximum Strength Cream
2020-07-22CORTAID Maximum Strength Cream

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZGCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
CETEARETH-6INACTIVE INGREDIENT2RJS3559D3CORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39CORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
VINYLPYRROLIDONE/EICOSENE COPOLYMERINACTIVE INGREDIENT035MV9S1C3CORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCORTAID MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1