Home Applications 088228 Application 088228
Type ANDA
Sponsor WOCKHARDT BIO AG Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SELENIUM SULFIDE SELENIUM SULFIDE LOTION/SHAMPOO;TOPICAL 2.5% No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088228-001 SELENIUM SULFIDE SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT 1983-09-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088228-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL 1983-09-01 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 2 of 3 · 43 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Head and Shoulders 2in1 Clinical Strength Dry Scalp Rescue SELENIUM SULFIDE The Procter & Gamble Manufacturing Company 2d041983-5750-e0f1-e063-6394a90a5b9e 2025-01-31 Warnings Name fallback generic name: SELENIUM SULFIDE Head and Shoulders Clinical Strength Advanced Oil Control SELENIUM SULFIDE The Procter & Gamble Manufacturing Company 2ccaceed-9928-ef05-e063-6394a90a6511 2025-01-28 Warnings Name fallback generic name: SELENIUM SULFIDE Meijer Medicated Selenium Sulfide Anti-Dandruff SELENIUM SULFIDE Meijer Distribution, Inc 41b563c6-5df6-4ead-bddf-a69a07970ea0 2025-01-14 Warnings Name fallback generic name: SELENIUM SULFIDE NATURALTECH PURIFYING ANTI-DANDRUFF SELENIUM SULFIDE Davines S.p.A. 369a24fd-3882-4fad-b57a-45806090aff1 2024-12-11 Warnings Name fallback generic name: SELENIUM SULFIDE Hairitage Wash It Away Anti-Dandruff for Oily, Flaky Scalp SELENIUM SULFIDE Maesa, LLC. b09c3b0d-564e-45e4-b6ff-c1f0c12a9521 2024-11-13 Warnings Name fallback generic name: SELENIUM SULFIDE Hairitage Wash It Away Anti-Dandruff for Dry, Flaky Scalp SELENIUM SULFIDE Maesa, LLC. fa5d4ee3-fbeb-4379-bbd3-2b5b2cc45430 2024-11-12 Warnings Name fallback generic name: SELENIUM SULFIDE Equate Medicated Dandruff Anti-Dandruff SELENIUM SULFIDE Wal-Mart Stores, Inc. 3afbdc09-622d-4681-a6fb-8429a0a3df39 2024-11-07 Warnings Name fallback generic name: SELENIUM SULFIDE Walgreens Dandruff and Conditioner Cleansing and Conditioning Anti-dandruff SELENIUM SULFIDE Walgreen Company dbcaeae8-4680-41d8-84e2-896183d2121d 2024-11-01 Warnings Name fallback generic name: SELENIUM SULFIDE Walgreens Dandruff Maximum Strength Anti-dandruff SELENIUM SULFIDE Walgreen Company 0187b034-44d7-4b84-af04-d018bc9750f3 2024-11-01 Warnings Name fallback generic name: SELENIUM SULFIDE FAMILY Wellness MAXIMUM STRENGTH DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE FAMILY DOLLAR SERVICES INC 41a808e1-67a7-4b29-8ec4-d6c13cf62243 2024-10-21 Warnings Name fallback generic name: SELENIUM SULFIDE CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruff SELENIUM SULFIDE CVS Health cff51af6-84de-4ba5-ac99-9bc42a65c9a5 2024-09-24 Warnings Name fallback generic name: SELENIUM SULFIDE up and up Moisturizing Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE TARGET CORPORATION e315b2d8-304d-4807-9594-9286e9b642ef 2024-05-10 Warnings Name fallback generic name: SELENIUM SULFIDE Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitis SELENIUM SULFIDE Walgreen Company cc83427d-49e6-4a20-9d03-9ec8ce27e487 2024-05-09 Warnings Name fallback generic name: SELENIUM SULFIDE meijer MEDICATED selenium sulfide Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE Meijer Distribution, Inc c8dee061-3362-400f-aa59-93ec0b8125ba 2024-05-01 Warnings Name fallback generic name: SELENIUM SULFIDE Walgreens Dandruff With Menthol/Selenium Sulfide Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE Walgreen Company 70c7b400-a295-4b99-8673-e6a38343d76f 2024-05-01 Warnings Name fallback generic name: SELENIUM SULFIDE up and up Medicated Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE TARGET CORPORATION a516282f-ed6b-4e94-b269-ea34f700dd69 2024-04-25 Warnings Name fallback generic name: SELENIUM SULFIDE Rugby Anti-Dandruff SELENIUM SULFIDE Rugby Laboratories f8942f2b-32fb-4a2d-b0cf-0f2d1c6974c2 2024-03-14 Warnings Name fallback generic name: SELENIUM SULFIDE Leader Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-Dandruff SELENIUM SULFIDE Cardinal Health, 110 dba LEADER 3f64a2ef-a415-49b0-bf14-eb4da66d511f 2024-03-13 Warnings Name fallback generic name: SELENIUM SULFIDE amazon basics maximum strength dandruff Anti-dandruff SELENIUM SULFIDE AMAZON.COM SERVICES LLC 194e4c51-ff7b-4def-a71d-efa5dfca3efd 2024-02-26 Warnings Name fallback generic name: SELENIUM SULFIDE Prosoria Medicated SELENIUM SULFIDE Nuvothera, Inc. 44eaaeb0-1400-4697-85d0-e8c2282c1cba 2024-01-11 Warnings Name fallback generic name: SELENIUM SULFIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-2166 Selenium Sulfide Selenium Sulfide A-S Medication Solutions ANDA Current 50090-2166 SELENIUM SULFIDE selenium sulfide A-S Medication Solutions ANDA Current 60432-528 SELENIUM SULFIDE selenium sulfide Morton Grove Pharmaceuticals, Inc. ANDA Current 76413-123 Selenium Sulfide Selenium Sulfide Central Texas Community Health Centers ANDA Current