Eurax

Product NDC: 10631-091
11-digit product format: 106310091
Labeler code: 10631
Product ID: 10631-091_f87f6e5f-30bc-4658-b7ed-7c2a823522a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: crotamiton
Dosage form: CREAM
Route: TOPICAL
Labeler: Ranbaxy Laboratories Inc.
Application: NDA006927
Marketing category: NDA
Marketing start: 2008-12-15
Marketing end: 0000-00-00
Substance: CROTAMITON
Active strength: 100 mg/g
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10631-091		D	Discontinued by firm		2026-08-11
excluded package	package	10631-091	10631-091-60	D	Discontinued by firm		2026-08-11

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	10631-091-60	`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	10631-091-60	`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	10631-091-60	`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	10631-091-60	`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	10631-091-60	`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	10631-091-60	`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	10631-091-60	`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	10631-091-60	`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	10631-091-60	`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	10631-091-60	`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	10631-091-60	`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	10631-091-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N006927-001	EURAX	CROTAMITON	10%	CREAM / TOPICAL		RLD, RS, Approved before 1982

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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N006927-001	EURAX	10%	CREAM / TOPICAL	RLD, Approved before 1982	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10631-091-60	GM - Gram	10631-091	8d49c344-339d-479c-a805-4c763fead733	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CROTAMITON	ACTIVE INGREDIENT	D6S4O4XD0H	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
CROTAMITON	ACTIVE MOIETY	D6S4O4XD0H	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
LAURETH-23	INACTIVE INGREDIENT	N72LMW566G	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
MAGNESIUM NITRATE	INACTIVE INGREDIENT	77CBG3UN78	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
STEARETH-2	INACTIVE INGREDIENT	V56DFE46J5	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]	3

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
Eurax	CROTAMITON	Journey Medical Corporation	99c826aa-c7dd-4e60-be9c-e9c151033d13	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006927 application number: NDA006927

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D6S4O4XD0H	CROTAMITON	483-63-6	CROTAMITON

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eurax	Ranbaxy Laboratories Inc. \| DPT Laboratories, Ltd	2015-01-30	HUMAN PRESCRIPTION DRUG LABEL	3