SELENIUM SULFIDE

Product NDC
45802-040
11-digit product format
458020040
Labeler code
45802
Product ID
45802-040_88f77de3-64b1-4ef8-9b6f-39c54ba9f9e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SELENIUM SULFIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA089996
Marketing category
ANDA
Marketing start
2006-09-25
Substance
SELENIUM SULFIDE
Active strength
2.5 mg/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
SELENIUM SULFIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENIUM SULFIDE2.5 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z69D9E381QInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
28b84e3c-ae44-40bb-93c4-2625e19f7e61Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-040-64SELENIUM SULFIDE118 mL in 1 BOTTLELOTION1188

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-040-64ML - Milliliter45802-0406af7df0a-b6f8-44b9-a00d-990f4651fe3612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SELENIUM SULFIDEACTIVE INGREDIENTZ69D9E381QSELENIUM SULFIDE LOTION [PERRIGO NEW YORK INC]3
SELENIUM SULFIDEACTIVE INGREDIENTZ69D9E381QSELENIUM SULFIDE LOTION [PHYSICIANS TOTAL CARE, INC.]3
SELENIUM SULFIDEACTIVE MOIETYZ69D9E381QSELENIUM SULFIDE LOTION [PHYSICIANS TOTAL CARE, INC.]3
SELENIUM SULFIDEACTIVE MOIETYZ69D9E381QSELENIUM SULFIDE LOTION [PERRIGO NEW YORK INC]3
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CSELENIUM SULFIDE LOTION [PERRIGO NEW YORK INC]3
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CSELENIUM SULFIDE LOTION [PHYSICIANS TOTAL CARE, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSELENIUM SULFIDE LOTION [PERRIGO NEW YORK INC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSELENIUM SULFIDE LOTION [PHYSICIANS TOTAL CARE, INC.]3
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0ESELENIUM SULFIDE LOTION [PERRIGO NEW YORK INC]3
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0ESELENIUM SULFIDE LOTION [PHYSICIANS TOTAL CARE, INC.]3
LAURIC DIETHANOLAMIDEINACTIVE INGREDIENTI29I2VHG38SELENIUM SULFIDE LOTION [PHYSICIANS TOTAL CARE, INC.]3
LAURIC DIETHANOLAMIDEINACTIVE INGREDIENTI29I2VHG38SELENIUM SULFIDE LOTION [PERRIGO NEW YORK INC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSELENIUM SULFIDE LOTION [PERRIGO NEW YORK INC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSELENIUM SULFIDE LOTION [PHYSICIANS TOTAL CARE, INC.]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSELENIUM SULFIDE LOTION [PHYSICIANS TOTAL CARE, INC.]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSELENIUM SULFIDE LOTION [PERRIGO NEW YORK INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSELENIUM SULFIDE LOTION [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSELENIUM SULFIDE LOTION [PERRIGO NEW YORK INC]3
WATERINACTIVE INGREDIENT059QF0KO0RSELENIUM SULFIDE LOTION [PHYSICIANS TOTAL CARE, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RSELENIUM SULFIDE LOTION [PERRIGO NEW YORK INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-040SELENIUM SULFIDE LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 1 package rows20230215_28b84e3c-ae44-40bb-93c4-2625e19f7e61.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
ndc (product): 45802-040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238600selenium sulfide 2.5 % Topical SuspensionPSN4a90c2c6-f2a5-4c0d-8879-b7d6863ea1793
238600selenium sulfide 25 MG/ML Medicated ShampooSCD4a90c2c6-f2a5-4c0d-8879-b7d6863ea1793
238600selenium sulfide 2.5 % Lotion ShampooSY4a90c2c6-f2a5-4c0d-8879-b7d6863ea1793
238600selenium sulfide 2.5 % Medicated ShampooSY4a90c2c6-f2a5-4c0d-8879-b7d6863ea1793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-040-6445802004064118 mL in 1 BOTTLE (45802-040-64) 118 ml2006-09-250000-00-00NoNoCurrent