Hydrocortisone Maximum Strength with Aloe

Product NDC
63187-567
Requested package NDC
63187-567-01
11-digit product format
631870567
Labeler code
63187
Product ID
63187-567_aa75144e-e1b4-4a63-ae25-d3d3a18513de
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-04-21
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63187-56763187-567-01DDiscontinued by firm2026-10-16

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-567-01GM - Gram63187-567ae2d0f38-c39d-4cab-ae1d-c327f875968b12016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FHYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-567-01631870567011 TUBE in 1 CARTON (63187-567-01) > 28 g in 1 TUBE1 tube2018-12-010000-00-00NoNoCurrent