Fluocinonide

Product NDC
68682-992
Requested package NDC
68682-992-60
11-digit product format
686820992
Labeler code
68682
Product ID
68682-992_3eef7cec-5fc1-457b-96a1-139870d1d643
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Oceanside Pharmaceuticals
Application
NDA021758
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-06
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68682-99268682-992-60DDiscontinued by firm2026-10-02

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021758-001VANOSFLUOCINONIDE0.1%CREAM / TOPICALABRLD, RS2005-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021758-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-1184e616aacf4f…
2026-08-18 06:07:402026-07N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-113f01610625f2…
2019-09-15 20:21 UTC2019-09N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021758-001VANOS0.1%CREAM / TOPICALABRLD, RS2005-02-11f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021758-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N021758-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021758-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021758-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021758-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021758-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021758-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021758-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021758-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021758-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021758-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021758-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021758-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021758-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021758-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021758-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021758-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021758-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021758-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021758-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021758-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021758-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021758-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021758-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021758-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021758-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021758-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021758-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021758-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021758-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021758-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021758-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021758-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021758-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021758-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021758-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021758-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021758-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021758-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021758-001AB1f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021758-00177947382022-09-11U-10845c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021758-00172204242023-01-07U-8615c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021758-00182322642023-03-09Drug product2012-08-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021758-00177947382022-09-11U-10845d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021758-00172204242023-01-07U-8615d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021758-00182322642023-03-09Drug product2012-08-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021758-00177947382022-09-11U-10844b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021758-00172204242023-01-07U-8614b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021758-00182322642023-03-09Drug product2012-08-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021758-00167650012021-12-21Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021758-00177947382022-09-11U-108474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021758-00172204242023-01-07U-86174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021758-00182322642023-03-09Drug product2012-08-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021758-00177947382022-09-11U-1084bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021758-00172204242023-01-07U-861bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021758-00182322642023-03-09Drug product2012-08-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021758-00167650012021-12-21Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021758-00177947382022-09-11U-1084782e0a99824c…
2021-12-28 21:50 UTC2021-12N021758-00172204242023-01-07U-861782e0a99824c…
2021-12-28 21:50 UTC2021-12N021758-00182322642023-03-09Drug product2012-08-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021758-00167650012021-12-21Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021758-00177947382022-09-11U-108487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021758-00172204242023-01-07U-86187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021758-00182322642023-03-09Drug product2012-08-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N021758-00167650012021-12-21Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021758-00177947382022-09-11U-10845aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021758-00172204242023-01-07U-8615aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021758-00182322642023-03-09Drug product2012-08-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021758-00167650012021-12-21Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021758-00177947382022-09-11U-10848869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021758-00172204242023-01-07U-8618869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021758-00182322642023-03-09Drug product2012-08-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021758-00167650012021-12-21Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021758-00177947382022-09-11U-1084c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021758-00172204242023-01-07U-861c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021758-00182322642023-03-09Drug product2012-08-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021758-00167650012021-12-21Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021758-00177947382022-09-11U-10843f01610625f2…
2019-12-14 00:12 UTC2019-12N021758-00172204242023-01-07U-8613f01610625f2…
2019-12-14 00:12 UTC2019-12N021758-00182322642023-03-09Drug product2012-08-023f01610625f2…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-992-10GM - Gram68682-992b49e5f02-4ad9-491b-9ec5-892a54394d3c12014-02-04
68682-992-30GM - Gram68682-992a604c713-e348-4001-8b8a-9c1d3c6e1e8112014-02-04
68682-992-60GM - Gram68682-9929d765870-a3f6-4d34-8f16-6b6d5d1cfb3e12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinonideACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE CREAM [OCEANSIDE PHARMACEUTICALS]2
fluocinonideACTIVE MOIETY2W4A77YPANFLUOCINONIDE CREAM [OCEANSIDE PHARMACEUTICALS]2
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EFLUOCINONIDE CREAM [OCEANSIDE PHARMACEUTICALS]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPFLUOCINONIDE CREAM [OCEANSIDE PHARMACEUTICALS]2
diisopropanolamineINACTIVE INGREDIENT0W44HYL8T5FLUOCINONIDE CREAM [OCEANSIDE PHARMACEUTICALS]2
dimethyl isosorbideINACTIVE INGREDIENTSA6A6V432SFLUOCINONIDE CREAM [OCEANSIDE PHARMACEUTICALS]2
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4FLUOCINONIDE CREAM [OCEANSIDE PHARMACEUTICALS]2
peg-100 stearateINACTIVE INGREDIENTYD01N1999RFLUOCINONIDE CREAM [OCEANSIDE PHARMACEUTICALS]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINONIDE CREAM [OCEANSIDE PHARMACEUTICALS]2
waterINACTIVE INGREDIENT059QF0KO0RFLUOCINONIDE CREAM [OCEANSIDE PHARMACEUTICALS]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-992-60686820992601 TUBE in 1 CARTON (68682-992-60) > 60 g in 1 TUBE1 tube2014-01-060000-00-00NoNoCurrent