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 25 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kenkoderm Eczema Honey Soothing BodyKENKODERM ECZEMA HONEY SOOTHING BODY LOTIONGuangzhou Ariel Biotech Co., Ltd.4865c697-05fc-eac8-e063-6294a90ae5412026-01-14WarningsExact identifier
application number: M016
Gold Bond Medicated eczema reliefCOLLOIDAL OATMEALChattem, Inc.52744c77-278f-40b1-a356-14ae4366389b2026-01-14WarningsExact identifier
application number: M016
Water Drench Hyaluronic Healing BalmDIMETHICONEPeter Thomas Roth Labs, LLC3f789176-1d80-d146-e063-6294a90a948a2026-01-13WarningsExact identifier
application number: M016
DERMEDIAL Anti-ItchOATMEAL, ZINC OXIDESaje Natural Business Inc385dd757-740b-8324-e063-6294a90afeee2026-01-13WarningsExact identifier
application number: M016
Sweet cheeksZINC OXIDESaje Natural Business Inc.5fc6486e-8604-5c7b-e053-2991aa0a8d142026-01-13WarningsExact identifier
application number: M016
TeevodarALLANTOINPEER PHARM LTD.57a1b6d1-9439-462b-aeb9-ef806e572eaf2026-01-12WarningsExact identifier
application number: M016
Botao Baby Diaper Rash CreamZINC OXIDEPeer Pharm Ltd.df60a70e-e6c0-41b3-e053-2995a90af1762026-01-12WarningsExact identifier
application number: M016
ECZEMA HAND RELIEFCOLLOIDAL OATMEALSkinfix, Inc.0389bab7-04fb-7cfc-e063-6394a90a22d82026-01-12WarningsExact identifier
application number: M016
SKINFIX HAND REPAIROATMEALSkinfix, Inc.1b65fc81-1b9e-4260-829a-332cf6891d022026-01-12WarningsExact identifier
application number: M016
ECZEMA INTENSIVE DAILY RELIEF BODYCOLLOIDAL OATMEAL CREAMSkinfix, Inc.0be3c631-bc9b-00a9-e063-6394a90abcbb2026-01-12WarningsExact identifier
application number: M016
SarnaCOLLOIDAL OATMEALCrown Laboratories, Inc.2d6b1872-9f4d-9eb3-e063-6394a90ab6752026-01-12WarningsExact identifier
application number: M016
XIMONTH Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.47f1a711-5d6f-c023-e063-6294a90aa8012026-01-09WarningsExact identifier
application number: M016
Endit zinc oxide skin protectionZINC OXIDEEndIt Laboratories, Inc.e60bb0da-3349-f8f9-e053-2a95a90a90512026-01-09WarningsExact identifier
application number: M016
Endit Zinc Oxide Skin ProtectantZINC OXIDEEndit Laboratories, Inc.55b3aa07-871d-421b-b76a-c2d359d6003f2026-01-09WarningsExact identifier
application number: M016
Flanders ButtocksWHITE PETROLATUM, ZINC OXIDEFlanders Inc32371159-c76d-41b0-e054-00144ff88e882026-01-09WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC47da77ea-ab4e-fc3c-e063-6394a90a27b72026-01-08WarningsExact identifier
application number: M016
Z-BumDIAPER RASH CREAMGM Pharmaceuticals, Inc2a36f396-3a30-3f3f-e054-00144ff8d46c2026-01-08WarningsExact identifier
application number: M016
Daily VLotionDIMETHICONEKindra1cc4b804-6483-68fd-e063-6294a90a38e42026-01-08WarningsExact identifier
application number: M016
V Relief SerumDIMETHICONEKindra1cd8a9e9-ac88-1799-e063-6294a90a32782026-01-08WarningsExact identifier
application number: M016
DR SMITHS DIAPERZINC OXIDEMission Pharmacal7705b182-acf7-4195-9996-7d9fcdfbf0552026-01-08WarningsExact 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