Cortifoam

Product NDC: 0037-6830
11-digit product format: 000376830
Labeler code: 0037
Product ID: 0037-6830_c53f12f0-249b-4462-b669-b9ae2b626051
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone acetate
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Viatris Specialty LLC
Application: NDA017351
Marketing category: NDA
Marketing start: 2015-06-15
Substance: HYDROCORTISONE ACETATE
Active strength: 1500 mg/15g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017351-001	CORTIFOAM	HYDROCORTISONE ACETATE	10%	AEROSOL, METERED / RECTAL		RLD, RS	1982-02-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017351-001	CORTIFOAM	10%	AEROSOL, METERED / RECTAL	RLD, RS	1982-02-10	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cortifoam
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE ACETATE	1500 mg/15g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X7931PO74	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1545172	Internal RxNorm lookup
1545174	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0093b694-9fcb-46ae-b1ab-7d0fa204c6c8	Available on FDA.report

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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0037-6830-15	Cortifoam	15 g in 1 CANISTER	AEROSOL, FOAM	15		10
0037-6830-15	Cortifoam	1 in 1 CARTON	AEROSOL, FOAM	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0037-6830-15	GM - Gram	0037-6830	f5b82942-098c-47d6-a974-ee1bdff00238	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE ACETATE	ACTIVE INGREDIENT	3X7931PO74	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
ETHYLENE DISTEARAMIDE	INACTIVE INGREDIENT	603RP8TB9A	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
ISOBUTANE	INACTIVE INGREDIENT	BXR49TP611	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
PROPANE	INACTIVE INGREDIENT	T75W9911L6	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
STEARETH-10	INACTIVE INGREDIENT	FD0913P475	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0037-6830	CORTIFOAM (HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]	9	Current NDC, Legacy NDC, 2 package rows	20250309_0093b694-9fcb-46ae-b1ab-7d0fa204c6c8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortifoam	HYDROCORTISONE ACETATE	Viatris Specialty LLC	0093b694-9fcb-46ae-b1ab-7d0fa204c6c8	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017351 application number: NDA017351 ndc (product): 0037-6830

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1545174	cortifoam 10 % Rectal Foam	PSN	0093b694-9fcb-46ae-b1ab-7d0fa204c6c8	10
1545172	hydrocortisone acetate 10 % Rectal Foam	PSN	0093b694-9fcb-46ae-b1ab-7d0fa204c6c8	10
1545174	hydrocortisone acetate 100 MG/ML Rectal Foam [Cortifoam]	SBD	0093b694-9fcb-46ae-b1ab-7d0fa204c6c8	10
1545172	hydrocortisone acetate 100 MG/ML Rectal Foam	SCD	0093b694-9fcb-46ae-b1ab-7d0fa204c6c8	10
1545174	Cortifoam 10 % Rectal Foam	SY	0093b694-9fcb-46ae-b1ab-7d0fa204c6c8	10
1545174	Cortifoam 100 MG/ML Rectal Foam	SY	0093b694-9fcb-46ae-b1ab-7d0fa204c6c8	10
1545172	hydrocortisone acetate 10 % Rectal Foam	SY	0093b694-9fcb-46ae-b1ab-7d0fa204c6c8	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0037-6830-15	00037683015	1 CANISTER in 1 CARTON (0037-6830-15) / 15 g in 1 CANISTER	1 canister	2015-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cortifoam - Viatris Specialty LLC	Viatris Specialty LLC	2024-05-15	HUMAN PRESCRIPTION DRUG LABEL	10