Home NDC 50157-125 PYRITHIONE ZINC
Product NDC 50157-125
11-digit product format 501570125
Labeler code 50157
Product ID 50157-125_e65f7070-4f57-8661-e053-2995a90a9579
Type HUMAN OTC DRUG
Nonproprietary name PYRITHIONE ZINC
Dosage form SHAMPOO
Route TOPICAL
Labeler BRANDS INTERNATIONAL
Application M032
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-16
Marketing end 0000-00-00
Substance PYRITHIONE ZINC
Active strength 0 g/100mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50157-125-35 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50157-125-10 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50157-125-35 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50157-125-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50157-125-35 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50157-125-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50157-125-35 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50157-125-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50157-125-35 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50157-125-10 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50157-125-35 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50157-125-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50157-125-10 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50157-125-35 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50157-125-10 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50157-125-35 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50157-125-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50157-125-35 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50157-125-10 PYRITHIONE ZINC 295 mL in 1 BOTTLE SHAMPOO 295 3 50157-125-35 PYRITHIONE ZINC 355 mL in 1 BOTTLE SHAMPOO 355 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50157-125 PYRITHIONE ZINC SHAMPOO [BRANDS INTERNATIONAL] 3 Legacy NDC, 2 package rows 20230805_e65f69d2-233f-9ebf-e053-2995a90a720e.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 18 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief Serum PYRITHIONE ZINC The Procter & Gamble Manufacturing Company 402e2561-e309-46f2-e063-6394a90a4e58 2025-10-02 Warnings Exact identifier application number: M032 J1002902 Jason Dandruff Relief 2in1 Treatment PYRITHIONE ZINC The Hain Celestial Group Inc 8c631014-3832-78cb-e053-2995a90a8d22 2025-10-01 Warnings Exact identifier application number: M032 iBeaLee 5% Minoxidil Hair Regrowth Solution MINOXIDIL Shenzhen Earth Surface Trading Co., Ltd. 40001edd-d98c-4e2a-e063-6394a90a9911 2025-09-30 Warnings Exact identifier application number: M032 Head and Shoulders Dry Scalp Complete Hydration 2in1 PYRITHIONE ZINC The Procter & Gamble Manufacturing Company 3f66839a-0d8f-e476-e063-6294a90a547c 2025-09-22 Warnings Exact identifier application number: M032 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin MINOXIDIL Shenzhen Ctrip Technology Co., Ltd. 1eae27bc-1b18-ae5d-e063-6394a90a4610 2025-09-12 Warnings Exact identifier application number: M032 Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil Control SELENIUM SULFIDE The Procter & Gamble Manufacturing Company b6ad107b-024b-828f-e053-2995a90aae36 2025-09-04 Warnings Exact identifier application number: M032 Hermon Folliculitis Shampoo. SALICYLIC ACID 2% Beautivity LLC 3c5f7caa-a4af-2574-e063-6394a90a7507 2025-08-14 Warnings Exact identifier application number: M032 Pert 2 in 1 Advanced plus SALICYLIC ACID Sodalis USA, LLC 0eaed46c-ae6f-0d58-e063-6394a90ad2a3 2025-08-13 Warnings Exact identifier application number: M032 RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar PYRITHIONE ZINC 2% RoyceDerm LLC 3b98a83d-9c3b-9522-e063-6294a90a7033 2025-08-05 Warnings Exact identifier application number: M032 Earthmed FS Psoriasis relief SALICYLIC ACID Earthmed LLC 3ba584bc-f40a-ce0a-e063-6394a90aebf7 2025-08-05 Warnings Exact identifier application number: M032 Pert 2 in 1 Extra Strength SALICYLIC ACID Sodalis USA, LLC 25c8a46c-4400-709f-e063-6394a90a3f31 2025-07-30 Warnings Exact identifier application number: M032 anti-fungal ANTI-FUNGAL SHAMPOO GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd 3b102d15-f2ce-5727-e063-6294a90a23a9 2025-07-29 Warnings Exact identifier application number: M032 Earthmed Sport Anti itch and eczema relief SALICYLIC ACID Earthmed LLC 3b14913b-3aab-9dd0-e063-6394a90a3b7f 2025-07-29 Warnings Exact identifier application number: M032 Soothing psoriasis and eczema relief SALICYLIC ACID Carolina Cannabis Creations L.L.C 2bcad94d-1918-7f37-e063-6294a90a4744 2025-07-29 Warnings Exact identifier application number: M032 DANDRX ANTI-DANDRUFF ZINC PYRITHIONE dandRX LLC 399fb507-2263-962f-e063-6394a90ae9a8 2025-07-10 Warnings Exact identifier application number: M032 anti-dandruff ANTI-DANDRUFF SHAMPOO GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd 3979fb80-8091-c79e-e063-6394a90ae618 2025-07-09 Warnings Exact identifier application number: M032 CeraVe 2 in 1 Anti-Dandruff Hydrating Conditioner PYRITHIONE ZINC LOreal USA Products Inc 7f5ff142-15cb-44be-aa0e-ccd06de23300 2025-07-08 Warnings Exact identifier application number: M032 5% Minoxidil and 5% Rosemary for Hair Care MINOXIDIL TIKNOW LLC 1bb386d2-70c6-c487-e063-6294a90a19da 2025-07-07 Warnings Exact identifier application number: M032 Red Scalpfixer Anti Dandruff PYRINTHIONE ZINC Orange Lab, Inc 386c83c3-8d23-b3b0-e063-6394a90a27ee 2025-07-01 Warnings Exact identifier application number: M032 Dermabon Multi Symptom Psoriasis Control COAL TAR Dermabon de Chihuahua, S.A. de C.V. d5b739ba-e332-41f6-9343-6ad5cc981344 2025-07-01 Warnings Exact identifier application number: M032
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50157-125-10 50157012510 295 mL in 1 BOTTLE (50157-125-10) 295 ml 2022-08-16 0000-00-00 No No Current 50157-125-35 50157012535 355 mL in 1 BOTTLE (50157-125-35) 355 ml 2022-08-16 0000-00-00 No No Current