FDA.reportPublic FDA data

Vanicream Z-Bar

Product NDC
45334-392
11-digit product format
453340392
Labeler code
45334
Product ID
45334-392_5da5df64-16e4-ed05-e063-6294a90ad50c
Type
HUMAN OTC DRUG
Nonproprietary name
pyrithione zinc
Dosage form
SOAP
Route
TOPICAL
Labeler
Pharmaceutical Specialties, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
Marketing end
2026-10-31
Substance
PYRITHIONE ZINC
Active strength
2 g/100g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Vanicream Z-Bar

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC2 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45334-392-35Vanicream Z-Bar99 g in 1 CARTONSOAP992

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45334-392VANICREAM Z-BAR (PYRITHIONE ZINC) SOAP [PHARMACEUTICAL SPECIALTIES, INC.]2Current NDC, 1 package rows20241122_21c84000-5d08-ae53-e063-6294a90a2362.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 22 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Dandruff 2 in 1PYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c6289a3-2f09-c094-e063-6394a90a81f92025-01-23WarningsExact identifier
application number: M032
Tuymec Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOGuangzhou Zanming Trading Co., Ltd.2c62d04e-dcb6-a33e-e063-6394a90a2e8e2025-01-23WarningsExact identifier
application number: M032
QC Anti Dandruff T PlusCOAL TARChain Drug Marketing Association, Inc.2bea5414-c7bc-d010-e063-6294a90aa1382025-01-17WarningsExact identifier
application number: M032
Meijer Medicated Selenium Sulfide Anti-DandruffSELENIUM SULFIDEMeijer Distribution, Inc41b563c6-5df6-4ead-bddf-a69a07970ea02025-01-14WarningsExact identifier
application number: M032
D-COL Personal Hygiene Convenience kitPYRITHIONE ZINC AND CHLOROXYLENOLD-COL Inc273fcc6f-9c54-42b0-aa0c-9051457b13412025-01-14WarningsExact identifier
application number: M032
Equate Mens Ultra Sport 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.f8767db7-e208-4ccc-85f7-789e281c7f262025-01-10WarningsExact identifier
application number: M032
Equate Soft and Smooth 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.c759b347-bdfb-4ff5-a464-b40fa2efb8432025-01-10WarningsExact identifier
application number: M032
Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.d561e8d2-2761-422b-8f05-ac76d3a043eb2025-01-10WarningsExact identifier
application number: M032
Royal Oils by Head and Shoulders Sulfate Free Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyd73ab807-027f-7581-e053-2995a90ada832025-01-08WarningsExact identifier
application number: M032
Head and Shoulders Supreme Color Protect ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86ac3037-9ff2-25ea-e053-2a91aa0a43e32025-01-08WarningsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLCe5702ac7-e680-ab4b-e053-2995a90ad4422025-01-01WarningsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLCabaf1c64-1c4d-481a-9872-b64fcf82cc632025-01-01WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp CareSALICYLIC ACIDTAI GUK PHARM. CO., LTDe8bdad4d-d499-70a9-e053-2a95a90a5cd92025-01-01WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1SALICYLIC ACIDTAI GUK PHARM. CO., LTDe8bf3852-e963-7a48-e053-2995a90a5aa12025-01-01WarningsExact identifier
application number: M032
American CrewPYRITHIONE ZINCRevlon Consumer Products Corp9566b567-90be-4803-b940-e6a91750778f2024-12-30WarningsExact identifier
application number: M032
Kerastase Paris K Symbiose Serum Nuit Antipelliculaire Intensif Antidandruff TreatmentSALICYLIC ACIDL'Oreal USA Products Inc.d72688ed-d153-4eed-988f-5386eb68559d2024-12-30WarningsExact identifier
application number: M032
Dermaharmony Seborrheic DermatitisPYRITHIONE ZINCD3 Development, Inc.8d81521d-9e6f-1acf-e053-2995a90a92422024-12-20WarningsExact identifier
application number: M032
Dermaharmony Sulfur and Salicylic AcidSALICYLIC ACID, SULFURD3 Development, Inc.a1c61da2-7e7a-430a-e053-2995a90ad5942024-12-20WarningsExact identifier
application number: M032
Dermaharmony Bar PeppermintSALICYLIC ACID, SULFURD3 Development, Inc.af7060a9-986c-500e-e053-2a95a90a64382024-12-20WarningsExact identifier
application number: M032
Dermaharmony Bar PeppermintPYRITHIONE ZINCD3 Development, Inc.a19b74b0-88c6-6897-e053-2a95a90a73092024-12-20WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283707zinc pyrithione 2 % Medicated Bar SoapPSN21c84000-5d08-ae53-e063-6294a90a23622
283707zinc pyrithione 0.02 MG/MG Medicated Bar SoapSCD21c84000-5d08-ae53-e063-6294a90a23622
283707zinc pyrithione 2 % Medicated Bar SoapSY21c84000-5d08-ae53-e063-6294a90a23622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45334-392-354533403923599 g in 1 CARTON (45334-392-35) 99 g2024-10-012026-10-31NoNoHistorical