Cortizone 10 Cooling Cream Anti-Itch

Product NDC
41167-0031
11-digit product format
411670031
Labeler code
41167
Product ID
41167-0031_a3e167e1-5e04-4f4c-bc82-497421209d89
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Chattem, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-12-02
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct41167-0031DDiscontinued by firm2026-10-05
excluded packagepackage41167-003141167-0031-6DDiscontinued by firm2026-10-05

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 · 24 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 packagepackage41167-0031-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41167-0031-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41167-0031-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41167-0031-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41167-0031-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41167-0031-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41167-0031-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41167-0031-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41167-0031-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41167-0031-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41167-0031-6367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41167-0031-6557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6RCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
GINGERINACTIVE INGREDIENTC5529G5JPQCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
HYDROLYZED JOJOBA ESTERS (ACID FORM)INACTIVE INGREDIENTUDR641JW8WCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ4CORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
ICODEXTRININACTIVE INGREDIENT2NX48Z0A9GCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1ECORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7ICORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
OATINACTIVE INGREDIENTZ6J799EAJKCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
PPG-3 BENZYL ETHER MYRISTATEINACTIVE INGREDIENT8075L58MKOCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCORTIZONE 10 COOLING CREAM ANTI-ITCH (HYDROCORTISONE) CREAM [CHATTEM, INC.]1