Vanicream Z-Bar

Product NDC
45334-391
Requested package NDC
45334-391-01
11-digit product format
453340391
Labeler code
45334
Product ID
45334-391_d9e04c0e-f596-1d0a-e053-2a95a90aedf5
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SOAP
Route
TOPICAL
Labeler
Pharmaceutical Specialties, Inc.
Application
M032
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
2 g/100g
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45334-39145334-391-01DDiscontinued by firm2026-10-21

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

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 28 of 31 · 613 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea ButterPYRITHIONE ZINCRejoice International Inc.7d9bf611-db24-4915-9b13-b7b36f47711f2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptusPYRITHIONE ZINCRejoice International Inc.b05742fe-692f-45a3-9de0-5f3f08642d782024-02-28WarningsExact identifier
application number: M032
XtraCare Dandruff Hair WashSALICYLIC ACIDRejoice International1902e6bb-e829-4b1a-b85a-1394913c77ca2024-02-28WarningsExact identifier
application number: M032
amazon basics maximum strength dandruff Anti-dandruffSELENIUM SULFIDEAMAZON.COM SERVICES LLC194e4c51-ff7b-4def-a71d-efa5dfca3efd2024-02-26WarningsExact identifier
application number: M032
Doo Gro Braids Twists Locs Dandruff Control MoisturizingSALICYLIC ACIDJ. Strickland and Co.116f4f0d-66c7-49dd-e063-6394a90ab2b52024-02-15WarningsExact identifier
application number: M032
amazon basics therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARAMAZON.COM SERVICES LLCada1be0c-53a7-443c-bc3c-f7a26b5f96a92024-02-05WarningsExact identifier
application number: M032
Equate Dry Scalp 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.6440fdd9-daa8-4f15-bdee-33724993bd7b2024-02-01WarningsExact identifier
application number: M032
Equate Everyday Clean Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.4c84a67a-1f43-4f40-a172-271de7e767852024-01-29WarningsExact identifier
application number: M032
Equate Everyday Clean 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.c85095f2-5dbd-4822-a83a-dc3641c4a3302024-01-29WarningsExact identifier
application number: M032
HydrocortisoneANTIPRURITIC (ANTI-ITCH)Dynarex Corporation81dff9df-6f7e-49f0-e053-2a91aa0af7e72024-01-23WarningsExact identifier
application number: M032
Walgreens Original T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWalgreen Company42cc63ab-6f79-4544-8529-7b8c36021b182024-01-22WarningsExact identifier
application number: M032
True plus Real Therapeutic T plus Plus Original Strength Tar Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGarcoa, Inc.1f4c23d5-ca00-4387-abc7-59d9ef4719772024-01-22WarningsExact identifier
application number: M032
Walgreens Extra Strength T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWalgreen Company7f681386-976c-40f4-8b18-97413989ab782024-01-22WarningsExact identifier
application number: M032
Prosoria MedicatedSELENIUM SULFIDENuvothera, Inc.44eaaeb0-1400-4697-85d0-e8c2282c1cba2024-01-11WarningsExact identifier
application number: M032
Prosoria ScalpSALICYLIC ACIDNuvothera, Inc.52a98715-3e57-4b86-b91e-0ce433dc22bd2024-01-10WarningsExact identifier
application number: M032
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.f94f4481-c58e-4555-9863-cbaa2c4cdd072024-01-10WarningsExact identifier
application number: M032
Equate Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.408d57e4-a707-4826-a04c-99517dc9b5af2024-01-04WarningsExact identifier
application number: M032
Equate Extra Strength Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.986ac1ab-c7c3-40df-b41b-6f26cce22a432024-01-04WarningsExact identifier
application number: M032
Pert Plus 2 in 1 Anti-DandruffPYRITHIONE ZINCTCP HRB Holdingsecfa3d29-b54c-265c-e053-2995a90a80202024-01-01WarningsExact identifier
application number: M032
CeraVe Developed with Dermatologists Psoriasis MoisturizingSALICYLIC ACIDL'Oreal USA Products Inc51f27970-92d3-44ae-b2b1-d820719680fe2023-12-28WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45334-391-01453340391011 BAG in 1 CARTON (45334-391-01) > 100 g in 1 BAG1 bag2021-01-010000-00-00NoNoCurrent