SELENIUM SULFIDE

Product NDC
68071-1768
Requested package NDC
68071-1768-4
11-digit product format
680711768
Labeler code
68071
Product ID
68071-1768_c46d2f34-29cb-11fc-e053-2a95a90a84ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SELENIUM SULFIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA089996
Marketing category
ANDA
Marketing start
2006-09-25
Marketing end
0000-00-00
Substance
SELENIUM SULFIDE
Active strength
3 mg/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-176868071-1768-4IInactivated by FDA2026-08-17

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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

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
A089996-001SELENIUM SULFIDESELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-103f01610625f2…
2019-09-15 20:21 UTC2019-09A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089996-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089996-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089996-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089996-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089996-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089996-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089996-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A089996-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089996-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089996-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089996-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A089996-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089996-001AT1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1768-42023-01-30C16284748780-1f386c64a-2366-0266-e053-dadaa90a7c1aSelenium Sulfide Topical Suspension USP, 2.5% (Lotion)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1768-4SELENIUM SULFIDE118 mL in 1 BOTTLELOTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1768SELENIUM SULFIDE LOTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20210611_c46d25b5-d2db-61a3-e053-2a95a90a86d7.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SELENIUM SULFIDESELENIUM SULFIDEPadagis Israel Pharmaceuticals Ltd28b84e3c-ae44-40bb-93c4-2625e19f7e612025-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089996
application number: ANDA089996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1768-468071176804118 mL in 1 BOTTLE (68071-1768-4) 118 ml2021-06-100000-00-00NoNoCurrent