Itch and Rash Cream

Product NDC
69103-4506
11-digit product format
691034506
Labeler code
69103
Product ID
69103-4506_f19adc9a-00e1-54c6-e053-2995a90a9638
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Provision Medical Products
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-03-31
Marketing end
2024-07-01
Substance
HYDROCORTISONE
Active strength
10 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct69103-4506DDiscontinued by firm2026-10-05
excluded packagepackage69103-450669103-4506-3DDiscontinued 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 packagepackage69103-4506-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69103-4506-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69103-4506-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69103-4506-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69103-4506-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69103-4506-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69103-4506-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69103-4506-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69103-4506-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69103-4506-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69103-4506-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69103-4506-3557ba5c1ecfa…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 INGREDIENTWI4X0X7BPJITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGAITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1
WATERINACTIVE INGREDIENT059QF0KO0RITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69103-4506-36910345060325 PACKET in 1 CARTON (69103-4506-3) > .9 g in 1 PACKET25 packet2015-04-030000-00-00NoNoCurrent