Hydrocortisone

Product NDC: 0603-0535
11-digit product format: 006030535
Labeler code: 0603
Product ID: 0603-0535_78ef256f-10ee-4819-8b22-5b3c5dc54210
Type: HUMAN OTC DRUG
Nonproprietary name: hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Par Pharmaceutical
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2001-10-01
Marketing end: 2020-10-31
Substance: HYDROCORTISONE
Active strength: 10 mg/g
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	0603-0535		D	Discontinued by firm		2026-10-12
excluded package	package	0603-0535	0603-0535-50	D	Discontinued by firm		2026-10-12

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 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	0603-0535-50	`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	0603-0535-50	`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	0603-0535-50	`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	0603-0535-50	`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	0603-0535-50	`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	0603-0535-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-0535-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-0535-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-0535-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-0535-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-0535-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-0535-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
0603-0535-50	GM - Gram	0603-0535	c2fa4d5b-8020-4147-a4bf-2db17d6c3451	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
POLYSORBATE 40	INACTIVE INGREDIENT	STI11B5A2X	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
PROPYLENE GLYCOL MONOSTEARATE	INACTIVE INGREDIENT	MZM1I680W0	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
SORBITAN MONOPALMITATE	INACTIVE INGREDIENT	77K6Z421KU	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	HYDROCORTISONE CREAM [QUALITEST PHARMACEUTICALS]	4
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
POLYSORBATE 40	INACTIVE INGREDIENT	STI11B5A2X	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
PROPYLENE GLYCOL STEARATE	INACTIVE INGREDIENT	MZM1I680W0	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
SORBITAN MONOPALMITATE	INACTIVE INGREDIENT	77K6Z421KU	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [PROFICIENT RX LP]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	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	8ddf1662-f626-4987-b704-729c008fdd80	4
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	8ddf1662-f626-4987-b704-729c008fdd80	4
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	8ddf1662-f626-4987-b704-729c008fdd80	4
106258	hydrocortisone 1 % Topical Cream	SY	8ddf1662-f626-4987-b704-729c008fdd80	4
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	8ddf1662-f626-4987-b704-729c008fdd80	4
106258	hydrocortisone 1 % Topical Cream	PSN	fbb876c0-a026-4eec-ae3e-f1d61c4661de	1
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	fbb876c0-a026-4eec-ae3e-f1d61c4661de	1
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	fbb876c0-a026-4eec-ae3e-f1d61c4661de	1
106258	hydrocortisone 1 % Topical Cream	SY	fbb876c0-a026-4eec-ae3e-f1d61c4661de	1
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	fbb876c0-a026-4eec-ae3e-f1d61c4661de	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Maximum Strength	Par Pharmaceutical	2019-11-11	HUMAN OTC DRUG LABEL	8
Hydrocortisone Maximum Strength	Proficient Rx LP	2018-12-01	HUMAN OTC DRUG LABEL	2
Hydrocortisone Maximum Strength	A-S Medication Solutions	2017-09-25	HUMAN OTC DRUG LABEL	4
Hydrocortisone	Central Texas Community Health Centers	2016-04-08	HUMAN OTC DRUG LABEL	1