FDA.reportPublic FDA data

Satinique Anti Dandruff

Product NDC
10056-006
11-digit product format
100560006
Labeler code
10056
Product ID
10056-006_085bb064-0a35-cb0d-e063-6294a90a16a1
Type
HUMAN OTC DRUG
Nonproprietary name
PYRITHIONE ZINC
Dosage form
CREAM
Route
TOPICAL
Labeler
Access Business Group LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-29
Substance
PYRITHIONE ZINC
Active strength
9.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Satinique Anti Dandruff
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC9.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091088Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae71967e-110d-4fae-a966-8382ca62bc1fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10056-006-012021-10-26C16284748780-1ba0f9c33-4cb8-a910-e053-dadaa90a0b85Satinique Anti-Dandruff shampoo
10056-006-012021-01-29C16284748780-1ba0f9c33-4cb8-a910-e053-dadaa90a0b85Satinique Anti-Dandruff shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10056-006-01Satinique Anti Dandruff280 mL in 1 BOTTLECREAM2806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10056-006SATINIQUE ANTI DANDRUFF (PYRITHIONE ZINC) CREAM [ACCESS BUSINESS GROUP LLC]6Current NDC, Legacy NDC, 1 package rows20231023_ae71967e-110d-4fae-a966-8382ca62bc1f.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 11 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everyday Clean DandruffPYRITHIONE ZINCRetail Business Services, LLC8fb44204-b763-4aa5-a6db-94d1b4d98b652026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCRetail Business Services, LLCc1d8c237-1ca8-4fdb-ba94-787d3a9e61112026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp DandruffPYRITHIONE ZINCRetail Business Services, LLC592ec7c5-44b8-405b-88a2-f02aa6c620f02026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCRetail Business Services, LLC37357176-913d-4dd7-a565-ad21d4ad60a82026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCRetail Business Services, LLCc8c82495-f09a-4ec1-9036-e464845e02f92026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCRetail Business Services, LLCec9d36ae-cf4e-4841-a13e-5cb0fe64c4fa2026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCRetail Business Services, LLC841429c3-e15c-41cc-9ca8-6b5a21a215872026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCPublix Super Markets, Inc.56c2b8c2-69ea-4343-ae69-43f5966261c22026-02-05Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCPublix Super Markets, Inc.8a204a2c-6dcb-4fc4-b265-9b95da2042362026-02-05Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCHarris Teeter8594a944-a67e-4dbe-8d31-7099410ff4842026-02-04Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCAmazon.Com Services LLCe30896df-e4b2-4b1f-a226-a26055a4a1212026-02-03Warnings, Adverse reactionsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLC34c4abb5-6f96-4866-a37f-4f9be6c43f2b2026-01-30WarningsExact identifier
application number: M032
NATUREPLEX PSORIASISSALICYLIC ACIDNatureplex, LLC1efa3e8d-f80b-44f4-a233-187e3329dd8f2026-01-29WarningsExact identifier
application number: M032
Head and Shoulders Charcoal DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company69abc8fa-eee5-d36f-e053-2991aa0a940b2026-01-28WarningsExact identifier
application number: M032
WeCare Anti-DandruffANTIDANDRUFF SHAMPOODynarex Corporation7fad58a3-5537-f87a-e053-2991aa0a7cdb2026-01-28WarningsExact identifier
application number: M032
TriDerma Psoriasis Control Face and Body CreamSALICYLIC ACIDGenuine Virgin Aloe Corporation66eeaf72-1fb4-4df0-9198-41f1143c67b32026-01-27WarningsExact identifier
application number: M032
TRIDERMA Psoriasis ControlSALICYLIC ACIDGenuine Virgin Aloe Corporation16ba7145-0e8c-48b8-b557-43ac1be317ac2026-01-27WarningsExact identifier
application number: M032
DHS tar gelCOAL TARPerson and Coveye17bd664-748b-417c-a247-9acc7bc7eec32026-01-23WarningsExact identifier
application number: M032
Therapeutic TPlus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDGarcoa, Inc.620617e3-0ee1-469a-ad2b-0dda957627cc2026-01-21WarningsExact identifier
application number: M032
Aloe Coal 02 ConditionerPYRITHIONE ZINCT. SPRUILL, LLCe8e1fbe8-7de3-4a8e-bace-b7b2e4db18282026-01-19WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091088zinc pyrithione 0.95 % Medicated ShampooPSNae71967e-110d-4fae-a966-8382ca62bc1f6
1091088zinc pyrithione 9.5 MG/ML Medicated ShampooSCDae71967e-110d-4fae-a966-8382ca62bc1f6
1091088zinc pyrithione 0.95 % Medicated ShampooSYae71967e-110d-4fae-a966-8382ca62bc1f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10056-006-0110056000601280 mL in 1 BOTTLE (10056-006-01) 280 ml2017-03-290000-00-00NoNoCurrent