ELOCON

Product NDC
0085-3149
11-digit product format
000853149
Labeler code
0085
Product ID
0085-3149_157a3da8-e4cc-4360-9943-36d137c4315c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
CREAM
Route
TOPICAL
Labeler
Merck Sharp & Dohme Corp.
Application
NDA019625
Marketing category
NDA
Marketing start
1987-05-06
Marketing end
0000-00-00
Substance
MOMETASONE FUROATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0085-3149DDiscontinued by firm2026-08-17
excluded packagepackage0085-31490085-3149-01DDiscontinued by firm2026-08-17
excluded packagepackage0085-31490085-3149-02DDiscontinued by firm2026-08-17
excluded packagepackage0085-31490085-3149-03DDiscontinued by firm2026-08-17

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 · 48 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 packagepackage0085-3149-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0085-3149-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0085-3149-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0085-3149-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0085-3149-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0085-3149-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0085-3149-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0085-3149-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0085-3149-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0085-3149-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0085-3149-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0085-3149-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0085-3149-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0085-3149-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0085-3149-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0085-3149-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0085-3149-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0085-3149-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0085-3149-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0085-3149-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0085-3149-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0085-3149-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0085-3149-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0085-3149-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0085-3149-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0085-3149-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0085-3149-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0085-3149-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0085-3149-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0085-3149-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0085-3149-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0085-3149-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0085-3149-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0085-3149-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0085-3149-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0085-3149-03557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019625-001ELOCONMOMETASONE FUROATE0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-06
N019625-002ELOCONMOMETASONE FUROATE0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-19

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019625-001ELOCON0.1%CREAM / TOPICAL1987-05-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019625-002ELOCON0.1%CREAM / TOPICALRLD2013-04-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019625-001ELOCON0.1%CREAM / TOPICAL1987-05-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019625-002ELOCON0.1%CREAM / TOPICALRLD2013-04-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019625-001ELOCON0.1%CREAM / TOPICAL1987-05-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019625-002ELOCON0.1%CREAM / TOPICALRLD2013-04-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019625-001ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1987-05-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019625-002ELOCON0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD2013-04-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N019625-002AB1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0085-3149-012021-09-08These highlights do not include all the information needed to use ELOCON Cream safely and effectively. See full prescribing information for ELOCON Cream. ELOCON ® (mometasone furoate) Cream, 0.1% for topical use Initial U.S. Approval: 1987
0085-3149-022021-09-08These highlights do not include all the information needed to use ELOCON Cream safely and effectively. See full prescribing information for ELOCON Cream. ELOCON ® (mometasone furoate) Cream, 0.1% for topical use Initial U.S. Approval: 1987
0085-3149-032021-09-08These highlights do not include all the information needed to use ELOCON Cream safely and effectively. See full prescribing information for ELOCON Cream. ELOCON ® (mometasone furoate) Cream, 0.1% for topical use Initial U.S. Approval: 1987
0085-3149-012021-07-23These highlights do not include all the information needed to use ELOCON Cream safely and effectively. See full prescribing information for ELOCON Cream. ELOCON ® (mometasone furoate) Cream, 0.1% for topical use Initial U.S. Approval: 1987
0085-3149-022021-07-23These highlights do not include all the information needed to use ELOCON Cream safely and effectively. See full prescribing information for ELOCON Cream. ELOCON ® (mometasone furoate) Cream, 0.1% for topical use Initial U.S. Approval: 1987
0085-3149-032021-07-23These highlights do not include all the information needed to use ELOCON Cream safely and effectively. See full prescribing information for ELOCON Cream. ELOCON ® (mometasone furoate) Cream, 0.1% for topical use Initial U.S. Approval: 1987

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-3149-01GM - Gram0085-3149ae11225f-20e2-44dd-8adb-43f6c2c0cbfa12014-01-04
0085-3149-03GM - Gram0085-3149691aec71-b61a-4653-9edb-43a4967d2ef712014-01-04

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0085-3149-01000853149011 TUBE in 1 CARTON (0085-3149-01) > 15 g in 1 TUBE1 tube1987-05-060000-00-00NoNoCurrent
0085-3149-02000853149021 TUBE in 1 CARTON (0085-3149-02) > 5 g in 1 TUBE1 tube1987-05-060000-00-00NoNoCurrent
0085-3149-03000853149031 TUBE in 1 CARTON (0085-3149-03) > 50 g in 1 TUBE1 tube1987-05-060000-00-00NoNoCurrent