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
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 50157-125 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 50157-125 | 50157-125-10 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 50157-125 | 50157-125-35 | I | Inactivated by FDA | 2026-10-05 |
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.
| 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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50157-125-10 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5ba3-d83d-e063-dadaa90ab31f | Next Gen Dandruff Shampoo |
| 50157-125-35 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5ba3-d83d-e063-dadaa90ab31f | Next Gen Dandruff Shampoo |
DailyMed Package Descriptions#
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Leader Classic Clean Dandruff | PYRITHIONE ZINC | CARDINAL HEALTH 110, LLC. DBA LEADER | 5b22537d-d09c-5bd6-e063-6294a90a48ff | 2026-09-10 | Warnings | M032 |
| Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 2cc726c2-3747-6dbf-e063-6294a90a789f | 2026-09-09 | Warnings | M032 |
| Leader Maximum Strength Therapeutic Dandruff | SALICYLIC ACID | CARDINAL HEALTH 110, LLC. DBA LEADER | 5afb2260-5b50-de95-e063-6394a90a5a47 | 2026-09-08 | Warnings | M032 |
| ANTI-DANDRUFF | KETOCONAZOLE | Guangzhou ChuanMa International Trading Co.,Ltd. | 5ac93feb-eb6d-7563-e063-6294a90ad2e0 | 2026-09-05 | Warnings | M032 |
| Dr Marvel ANTI DANDRUFF SCALP SERUM | SELENIUM SULFIDE SALICYLIC ACID | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 5aaeddff-72f9-3687-e063-6394a90ae5dc | 2026-09-04 | Warnings | M032 |
| Head and Shoulders Scalp Restore Nourishing Conditioner | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 5a834d00-cc79-1a8e-e063-6294a90ab245 | 2026-09-02 | Warnings | M032 |
| Head and Shoulders Scalp Purify Clarifying Pre-Shampoo | SALICYLIC ACID | The Procter & Gamble Manufacturing Company | 5a84c545-4570-b078-e063-6394a90a8c5a | 2026-09-02 | Warnings | M032 |
| Head and Shoulders Scalp Purify Volumizing | SALICYLIC ACID | The Procter & Gamble Manufacturing Company | 5a8627ec-cfd8-d0f6-e063-6394a90ab488 | 2026-09-02 | Warnings | M032 |
| Head and Shoulders Scalp Soothe Cooling | SALICYLIC ACID | The Procter & Gamble Manufacturing Company | 5a87ed71-87e7-a7b7-e063-6294a90ac897 | 2026-09-02 | Warnings | M032 |
| Head and Shoulders Scalp Restore Nourishing | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 5a8a42d2-8610-1dfb-e063-6294a90abc7a | 2026-09-02 | Warnings | M032 |
| Koi Beauty 5% Minoxidil Hair Growth Kit | 5% MINOXIDIL HAIR GROWTH KIT | Beijing Sea Heart International Science And Technology Co.,Ltd. | 3b34f263-1232-4bb9-e063-6294a90a494d | 2026-08-27 | Warnings | M032 |
| SMOOTH AND SOFT DANDRUFF | PYRITHIONE ZINC | Universal Distribution Center LLC | 9e235139-07a2-469a-8601-db69379ce347 | 2026-08-24 | Warnings | M032 |
| ITCHY SCALP RELIEF DANDRUFF | PYRITHIONE ZINC | Universal Distribution Center LLC | 634019c2-03a3-4fed-939e-6f9a50ddea7b | 2026-08-24 | Warnings | M032 |
| Minoxidil Hair Regrowth Treatment | MINOXIDIL | Shenzhen Earth Surface Trading Co., Ltd. | 59b4f9e3-c241-6a70-e063-6294a90a364f | 2026-08-23 | Warnings | M032 |
| Minoxidil Hair Regrowth Treatment | MINOXIDIL | Shenzhen Earth Surface Trading Co., Ltd. | 59b52a52-dab0-87b5-e063-6294a90a0596 | 2026-08-23 | Warnings | M032 |
| Minoxidil Hair Regrowth Treatment | MINOXIDIL | Shenzhen Earth Surface Trading Co., Ltd. | 59b67ce0-3546-c18a-e063-6394a90ae50a | 2026-08-23 | Warnings | M032 |
| Anti Dandruff | KETOCONAZOLE | Guangzhou ChuanMa International Trading Co.,Ltd. | 599f2cce-0c27-d425-e063-6394a90a1565 | 2026-08-22 | Warnings | M032 |
| Anti Dandruff | KETOCONAZOLE | Guangzhou ChuanMa International Trading Co.,Ltd. | 59a0a062-92d1-210a-e063-6394a90a9bf9 | 2026-08-22 | Warnings | M032 |
| Ouai Anti-Dandruff | SALICYLIC ACID | The Procter & Gamble Manufacturing Company | 5990c45f-f653-b403-e063-6394a90a329d | 2026-08-21 | Warnings | M032 |
| Dermatology Psoriasis Cream | COAL TAR | G.M.J Natural Products, Inc. | 96cc5455-f3b8-4ded-a158-5de209d7bf0d | 2026-08-21 | Warnings | M032 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1052932 | zinc pyrithione 0.3 % Medicated Shampoo | PSN | e65f69d2-233f-9ebf-e053-2995a90a720e | 3 |
| 1052932 | zinc pyrithione 3 MG/ML Medicated Shampoo | SCD | e65f69d2-233f-9ebf-e053-2995a90a720e | 3 |
| 1052932 | zinc pyrithione 0.3 % Medicated Shampoo | SY | e65f69d2-233f-9ebf-e053-2995a90a720e | 3 |
Packages#
| 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 |