Quality Choice Maximum Strength Anti Itch

Product NDC
63868-594
11-digit product format
638680594
Labeler code
63868
Product ID
63868-594_98ff35d7-a46e-707c-e053-2a95a90a24e1
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Chain Drug Marketing Association Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-01-19
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 productproduct63868-594DDiscontinued by firm2026-10-05
excluded packagepackage63868-59463868-594-28DDiscontinued 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 · 30 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued 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 packagepackage63868-594-28DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63868-594-28IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63868-594-28IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63868-594-28IInactivated by FDAbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-594-28GM - Gram63868-59416608634-6708-4a32-b671-74f7597261ec12022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
CHAMOMILE FLOWER OILINACTIVE INGREDIENT60F80Z61A9QUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3QUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-594-28638680594281 TUBE in 1 CARTON (63868-594-28) > 28 g in 1 TUBE1 tube2015-01-200000-00-00NoNoCurrent