Facial Fortress

Product NDC
71566-200
11-digit product format
715660200
Labeler code
71566
Product ID
71566-200_9e7ed5d6-6bcd-41d9-a604-1e7bb36b5d87
Type
HUMAN OTC DRUG
Nonproprietary name
pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Pediatric Solutions, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-13
Substance
PYRITHIONE ZINC
Active strength
.0095 g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Facial Fortress
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC.0095 g/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
cdd3c52e-4c32-46c1-bdb3-957b164190bbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71566-200-08Facial Fortress237 mL in 1 BOTTLE, PLASTICSHAMPOO2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71566-200FACIAL FORTRESS (PYRITHIONE ZINC) SHAMPOO [PEDIATRIC SOLUTIONS, LLC]1Current NDC, 1 package rows20241213_cdd3c52e-4c32-46c1-bdb3-957b164190bb.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 55 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Baby Calming Comfort Bath Plus SetDIMETHICONEKenvue Brands LLC2c44fbc7-588f-41e2-953c-eebf24eecbf92024-11-06WarningsExact identifier
application number: M016
Aveeno Baby Welcome Little One Gift BasketDIMETHICONEKenvue Brands LLCe05e3c63-1691-7a86-e053-2a95a90a6bcb2024-11-06WarningsExact identifier
application number: M016
Avene XERACALM Eczema Calming Relief BalmCOLLOIDAL OATMEALPierre Fabre USA Inc.1315f006-0e96-2074-e063-6394a90a60372024-11-06WarningsExact identifier
application number: M016
Aveeno Baby Daily Moisture with Coconut Oil and Shea ButterDIMETHICONEKenvue Brands LLCeb71f8b1-bbcd-f338-e053-2995a90a80f12024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Daily MoisturizingCOLLOIDAL OATMEALKenvue Brands LLCe4c85780-7cb2-b55c-e053-2995a90a03142024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily Care SetDIMETHICONEKenvue Brands LLC62025bfa-245e-4369-9949-d31ea455ad312024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLCf2fd12cf-45c0-163f-e053-2a95a90ad4592024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily Care SetDIMETHICONEKenvue Brands LLC3d3da49e-dba6-4c6b-9278-5c8692e29f142024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Itch Relief BalmOATMEALKenvue Brands LLCbab3b767-864c-4c9f-b812-4fbd2bf2ca772024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC1bad1069-b169-4bc9-8eb8-5123d57f74e52024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLCe0d9b055-be7a-8bba-e053-2995a90ab9e32024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy daily moisturizingOATMEALKenvue Brands LLCdcbdb2ce-3877-41ea-9978-986e17a7c8772024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLC3879110f-ba83-446b-b580-f8eaa859789d2024-11-05WarningsExact identifier
application number: M016
Aveeno Daily MoisturizingDIMETHICONEKenvue Brands LLC70593b0c-c41b-4294-9bfa-42003ba1e3e42024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC029fbae2-06ad-4fe9-b542-834686c5cb972024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief OvernightDIMETHICONEKenvue Brands LLCe7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c2024-11-05WarningsExact identifier
application number: M016
Quality Choice Diaper RashZINC OXIDEChain Drug Marketing Association Inc.262e7eac-4b44-f224-e063-6394a90a4f592024-11-05WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEChain Drug Marketing Association Inc.262f8cab-c7b8-b07e-e063-6294a90a12892024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY926706b5-0a08-4604-b5ad-3b3ddfd7f02d2024-11-05WarningsExact identifier
application number: M016
Walgreens Eczema Relief Body Skin ProtectantOATMEALWalgreen Companyb2eebc2f-addd-4822-b224-04bd5f4506532024-11-05WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091088zinc pyrithione 0.95 % Medicated ShampooPSNcdd3c52e-4c32-46c1-bdb3-957b164190bb2
1091088zinc pyrithione 9.5 MG/ML Medicated ShampooSCDcdd3c52e-4c32-46c1-bdb3-957b164190bb2
1091088zinc pyrithione 0.95 % Medicated ShampooSYcdd3c52e-4c32-46c1-bdb3-957b164190bb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71566-200-0871566020008237 mL in 1 BOTTLE, PLASTIC (71566-200-08) 237 ml2024-12-13NoNoCurrent