Hydrocortisone with Aloe

Product NDC: 0904-7623
11-digit product format: 009047623
Labeler code: 0904
Product ID: 0904-7623_3e805912-e5f4-4542-9c12-c4b2212683fa
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Major Pharmaceuticals
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2009-04-21
Marketing end: 2025-01-31
Substance: HYDROCORTISONE
Active strength: 1 g/100g
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-7623		D	Discontinued by firm		2026-10-15
excluded package	package	0904-7623	0904-7623-31	D	Discontinued by firm		2026-10-15

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-7623-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-7623-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-7623-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-7623-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-7623-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-7623-31	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7623-31	GM - Gram	0904-7623	95ab2ee6-f625-4b51-b38c-ddc6a3b38228	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [MAJOR PHARMACEUTICALS]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106258	hydrocortisone 1 % Topical Cream	PSN	576fe736-cf19-4945-93c0-143d5fc98cbc	5
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	576fe736-cf19-4945-93c0-143d5fc98cbc	5
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	576fe736-cf19-4945-93c0-143d5fc98cbc	5
106258	hydrocortisone 1 % Topical Cream	SY	576fe736-cf19-4945-93c0-143d5fc98cbc	5
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	576fe736-cf19-4945-93c0-143d5fc98cbc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7623-31	00904762331	1 TUBE in 1 CARTON (0904-7623-31) > 28 g in 1 TUBE	1 tube	2009-04-21	2025-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Cream, USP 1% with Aloe	Proficient Rx LP	2024-02-01	HUMAN OTC DRUG LABEL	5
Hydrocortisone Cream with Aloe Maximum Strength - Major	Major Pharmaceuticals	2022-10-27	HUMAN OTC DRUG LABEL	8
Hydrocortisone Cream with Aloe Maximum Strength - Major	A-S Medication Solutions	2021-03-01	HUMAN OTC DRUG LABEL	5