FDA.reportPublic FDA data

Application 084394

Type
ANDA
Sponsor
ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SELENIUM SULFIDESELENIUM SULFIDELOTION/SHAMPOO;TOPICAL2.5%NoNo

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
A084394-001SELENIUM SULFIDESELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALApproved 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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A084394-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084394-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A084394-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALApproved before 1982a50c72e98297…

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermoia Seborrheic Dermatitis Selenium SulfideSELENIUM SULFIDETREASUREWISE LLC04b8532e-44a7-4eaf-a46d-87611ec93c242026-06-23WarningsName fallback
generic name: SELENIUM SULFIDE
Silvagle Selenium Sulfide Anti DandruffShampooSELENIUM SULFIDEGUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD54885ae3-7e2f-7bd2-e063-6394a90a97fe2026-06-18WarningsName fallback
generic name: SELENIUM SULFIDE
CVS Health MAXIMUM STRENGTH Dandruff Medicated Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Health307e4b16-10ab-44f4-86b9-709d10566d4c2026-06-04WarningsName fallback
generic name: SELENIUM SULFIDE
CVS GoldSELENIUM SULFIDEApollo Health and Beauty Care1d12ca6a-2734-0534-e063-6294a90a27062026-05-08WarningsName fallback
generic name: SELENIUM SULFIDE
DandruffSELENIUM SULFIDEH E B182ca790-0713-412a-9111-c0cf40f20d022026-02-24Warnings, Adverse reactionsName fallback
generic name: SELENIUM SULFIDE
DandruffSELENIUM SULFIDEMeijer, Inc.c0e4f8cb-74fc-4c0d-9721-f87aa2aa19922026-02-19Warnings, Adverse reactionsName fallback
generic name: SELENIUM SULFIDE
Selsun Blue 2-in-1SELENIUM SULFIDEChattem, Inc.f97e458c-cce3-498f-81fc-1b96a4e8f50a2026-02-18WarningsName fallback
generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Dandruff Defense Intensive Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb6ad7707-9d02-31a6-e053-2a95a90ae7ad2025-12-31WarningsName fallback
generic name: SELENIUM SULFIDE
Head and Shoulders 2in1 Clinical Strength Dandruff Defense Intensive Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb6ada541-f12b-76f2-e053-2a95a90a52862025-12-31WarningsName fallback
generic name: SELENIUM SULFIDE
SELENIUM SULFIDESELENIUM SULFIDEKMM Pharmaceuticals, LLCd9165c56-4c78-8d5a-e053-2995a90a6b2e2025-12-18Warnings, Adverse reactionsName fallback
brand name: SELENIUM SULFIDE
generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Dandruff Defense Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb69c4d1f-379f-be92-e053-2995a90ab7ad2025-12-16WarningsName fallback
generic name: SELENIUM SULFIDE
Selenium SulfideSELENIUM SULFIDELaser Pharmaceuticals, LLCa72001ce-42a2-4708-e053-2995a90a75932025-11-06Warnings, Adverse reactionsName fallback
brand name: Selenium Sulfide
generic name: SELENIUM SULFIDE
Selenium SulfideSELENIUM SULFIDELaser Pharmaceuticals, LLCdc6609b4-1757-3a13-e053-2995a90ac1722025-11-06Warnings, Adverse reactionsName fallback
brand name: Selenium Sulfide
generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company40464e2d-f738-33ec-e063-6394a90a02c22025-10-03WarningsName fallback
generic name: SELENIUM SULFIDE
Head and Shoulders 2in1 Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company4046c345-e1ac-0ecc-e063-6294a90a59fa2025-10-03WarningsName fallback
generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil ControlSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb6ad107b-024b-828f-e053-2995a90aae362025-09-04WarningsName fallback
generic name: SELENIUM SULFIDE
SELENIUM SULFIDESELENIUM SULFIDECintex Services, LLC3999e3e3-1c1b-bcf7-e063-6394a90aed502025-07-10Warnings, Adverse reactionsName fallback
brand name: SELENIUM SULFIDE
generic name: SELENIUM SULFIDE
SELENIUM SULFIDESELENIUM SULFIDEPadagis Israel Pharmaceuticals Ltd28b84e3c-ae44-40bb-93c4-2625e19f7e612025-05-31Warnings, Adverse reactionsName fallback
brand name: SELENIUM SULFIDE
generic name: SELENIUM SULFIDE
Selenium SulfideSELENIUM SULFIDEWestminster Pharmaceuticals, LLC9fcab751-28f4-485a-aa37-169318a611102025-04-23Warnings, Adverse reactionsName fallback
brand name: Selenium Sulfide
generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company3272a482-3813-63e4-e063-6394a90a43eb2025-04-10WarningsName fallback
generic name: SELENIUM SULFIDE

Reported adverse events (FAERS/openFDA)#

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