Cloderm

Product NDC: 67857-804
Requested package NDC: 67857-804-90
11-digit product format: 678570804
Labeler code: 67857
Product ID: 67857-804_47135e54-5a8a-575b-3a6c-541fbda7153f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clocortolone pivalate
Dosage form: CREAM
Route: TOPICAL
Labeler: Promius Pharma, LLC
Application: NDA017765
Marketing category: NDA
Marketing start: 1977-08-22
Marketing end: 0000-00-00
Substance: CLOCORTOLONE PIVALATE
Active strength: 0 g/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67857-804	67857-804-90	I	Inactivated by FDA		2026-08-03

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
N017765-001	CLODERM	CLOCORTOLONE PIVALATE	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N017765-001	AB

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	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017765-001	CLODERM	0.1%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017765-001	CLODERM	0.1%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017765-001	CLODERM	0.1%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017765-001	CLODERM	0.1%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017765-001	CLODERM	0.1%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017765-001	CLODERM	0.1%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017765-001	CLODERM	0.1%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017765-001	CLODERM	0.1%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017765-001	CLODERM	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017765-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017765-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017765-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017765-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017765-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017765-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017765-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017765-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017765-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017765-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017765-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017765-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017765-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017765-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017765-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017765-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017765-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N017765-001	AB	1	`bb7c543d1eb4…`
2020-11-12 02:37 UTC	2020-11	N017765-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017765-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017765-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017765-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017765-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017765-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017765-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017765-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017765-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017765-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017765-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017765-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017765-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017765-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017765-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5b4db253-13f4-a186-daf6-9b4e39d96457	Product name	2	20200729

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67857-804-45	Cloderm ® Cream, 0.1% (clocortolone pivalate)
67857-804-48	Cloderm ® Cream, 0.1% (clocortolone pivalate)
67857-804-51	Cloderm ® Cream, 0.1% (clocortolone pivalate)
67857-804-90	Cloderm ® Cream, 0.1% (clocortolone pivalate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67857-804-23	Cloderm	2 g in 1 TUBE	CREAM	2	7
67857-804-45	Cloderm	45 g in 1 TUBE	CREAM	45	7
67857-804-48	Cloderm	10 in 1 CARTON	CREAM	10	7
67857-804-51	Cloderm	75 g in 1 BOTTLE, PUMP	CREAM	75	7
67857-804-90	Cloderm	90 g in 1 TUBE	CREAM	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67857-804-30	GM - Gram	67857-804	2417c3bd-1896-451d-b35b-91225ecfc931	1	2012-07-24
67857-804-45	GM - Gram	67857-804	9c11f33b-523a-40b3-8442-102e84d2c2c7	1	2012-07-24
67857-804-51	GM - Gram	67857-804	1b2acf2f-6d5b-4334-8f48-c066fe95d4c4	1	2013-02-13
67857-804-90	GM - Gram	67857-804	302b5505-1d35-4f92-9aea-2203c1f5ee42	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
clocortolone pivalate	ACTIVE INGREDIENT	QBL8IZH14X	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
clocortolone	ACTIVE MOIETY	N8ZUB7XE0H	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
CARBOMER HOMOPOLYMER TYPE B	INACTIVE INGREDIENT	HHT01ZNK31	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67857-804	CLODERM (CLOCORTOLONE PIVALATE) CREAM [PROMIUS PHARMA, LLC]	7	Legacy NDC, 5 package rows	20190918_4abc01f2-03d4-43d5-a085-f452443cfca2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QBL8IZH14X	CLOCORTOLONE PIVALATE	34097-16-0	CLOCORTOLONE PIVALATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197520	clocortolone (as clocortolone pivalate) 0.1 % Topical Cream	PSN	4abc01f2-03d4-43d5-a085-f452443cfca2	7
206048	Cloderm 0.1 % Topical Cream	PSN	4abc01f2-03d4-43d5-a085-f452443cfca2	7
206048	clocortolone 1 MG/ML Topical Cream [Cloderm]	SBD	4abc01f2-03d4-43d5-a085-f452443cfca2	7
197520	clocortolone 1 MG/ML Topical Cream	SCD	4abc01f2-03d4-43d5-a085-f452443cfca2	7
197520	clocortolone (as clocortolone pivalate) 0.1 % Topical Cream	SY	4abc01f2-03d4-43d5-a085-f452443cfca2	7
206048	Cloderm 0.1 % Topical Cream	SY	4abc01f2-03d4-43d5-a085-f452443cfca2	7
206048	Cloderm 1 MG/ML Topical Cream	SY	4abc01f2-03d4-43d5-a085-f452443cfca2	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67857-804-90	67857080490	90 g in 1 TUBE (67857-804-90)	90 g	2011-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cloderm ® Cream, 0.1% (clocortolone pivalate)	Promius Pharma, LLC \| DPT Laboratories, LTD	2019-04-22	HUMAN PRESCRIPTION DRUG LABEL	7