Eurax

Product NDC
10631-092
11-digit product format
106310092
Labeler code
10631
Product ID
10631-092_f87f6e5f-30bc-4658-b7ed-7c2a823522a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
crotamiton
Dosage form
LOTION
Route
TOPICAL
Labeler
Ranbaxy Laboratories Inc.
Application
NDA009112
Marketing category
NDA
Marketing start
2008-11-13
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10631-092DDiscontinued by firm2026-08-11
excluded packagepackage10631-09210631-092-16DDiscontinued by firm2026-08-11
excluded packagepackage10631-09210631-092-60DDiscontinued by firm2026-08-11

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10631-092-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10631-092-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10631-092-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10631-092-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10631-092-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10631-092-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10631-092-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10631-092-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10631-092-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10631-092-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10631-092-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10631-092-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10631-092-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10631-092-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10631-092-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10631-092-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10631-092-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10631-092-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10631-092-16ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10631-092-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10631-092-16367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10631-092-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10631-092-16557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10631-092-60557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N009112-003EURAXCROTAMITON10%LOTION / TOPICALRLD, 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N009112-003EURAX10%LOTION / TOPICALATRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N009112-003AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009112-003AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N009112-003AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009112-003AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009112-003AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009112-003AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009112-003AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009112-003AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009112-003AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N009112-003AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009112-003AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009112-003AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N009112-003AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N009112-003AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N009112-003AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N009112-003AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N009112-003AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N009112-003AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N009112-003AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N009112-003AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N009112-003AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N009112-003AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N009112-003AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N009112-003AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N009112-003AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N009112-003AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N009112-003AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N009112-003AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N009112-003AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N009112-003AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N009112-003AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N009112-003AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N009112-003AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N009112-003AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N009112-003AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N009112-003AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N009112-003AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N009112-003AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N009112-003AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N009112-003AT1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10631-092-16GM - Gram10631-0923514378a-13af-44c7-8df1-f83ebdcd7ce612012-07-24
10631-092-60GM - Gram10631-0928397acbc-d5d6-49ee-b4c3-6b150b90645412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CROTAMITONACTIVE INGREDIENTD6S4O4XD0HEURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
CROTAMITONACTIVE MOIETYD6S4O4XD0HEURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNEURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OEURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
LAURETH-23INACTIVE INGREDIENTN72LMW566GEURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCEURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
MAGNESIUM NITRATEINACTIVE INGREDIENT77CBG3UN78EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNEURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAEURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UEURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IEURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
STEARETH-2INACTIVE INGREDIENTV56DFE46J5EURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3
WATERINACTIVE INGREDIENT059QF0KO0REURAX (CROTAMITON) CREAM EURAX (CROTAMITON) LOTION [RANBAXY LABORATORIES INC.]3