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 52 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCeaaf95d7-df80-407e-b784-4e42a89d64e52024-12-04WarningsExact identifier
application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec688073-6577-6cf9-e053-2a95a90a631d2024-12-04WarningsExact identifier
application number: M016
Burts Bees Rapid Rescue Cold Sore TreatmentCAMPHOR, GLYCERINBurts Bees9f89735d-205f-4d3e-a1e1-ecc96284fe982024-12-03WarningsExact identifier
application number: M016
Mustela Diaper Rash SprayableZINC OXIDEExpanscience Laboratories d/b/a Mustelad9a2aaf6-ab71-97a3-e053-2a95a90a34982024-12-02WarningsExact identifier
application number: M016
Mustela Stelatopia Intense Eczema Relief Skin ProtectantCOLLOIDAL OATMEALExpanscience Laboratories d/b/a Mustelae9ac358e-c9bd-7091-e053-2a95a90a46092024-12-02WarningsExact identifier
application number: M016
ZINC OXIDEZINC OXIDEVIVE HEALTH LLC284dbf6a-6fa2-742b-e063-6394a90afdfd2024-12-02WarningsExact identifier
application number: M016
Readyflush Protect Wipes Fragrance FreeDIMETHICONEMedline Industries, LP743d21bd-c40a-4415-ad97-0d8aa99a8af72024-12-02WarningsExact identifier
application number: M016
Orajel Cold Sore MoisturelockBENZOCAINEChurch & Dwight Co., Inc.3761c7b3-053b-0f50-e054-00144ff88e882024-11-26WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCed08b690-f907-6d2f-e053-2a95a90af51c2024-11-25WarningsExact identifier
application number: M016
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLCda5469ea-3330-4f04-e053-2a95a90aff412024-11-25WarningsExact identifier
application number: M016
Lil Drug Store Petroleum JellyPETROLATUMLil Drug Store Products, Inca8a56786-20c3-43c1-a4db-8502ff08e4cb2024-11-25WarningsExact identifier
application number: M016
TerrasilMed ONCALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsf0cc9448-c531-4dd1-8f5c-5310e4abe1a92024-11-25WarningsExact identifier
application number: M016
TN Dickinsons Witch Hazel AstringentWITCH HAZELDickinson Brands Inc.a9596cf1-8204-447d-90f6-622bf497a7e02024-11-25WarningsExact identifier
application number: M016
PINXAV DAIPER RASHZINC OXIDEEmjay Laboratories Inc.14daf592-8edf-4679-9abf-de1b9d0799ff2024-11-21WarningsExact identifier
application number: M016
Target Maximum Strength Zinc Oxide Diaper RashZINC OXIDE DIAPER RASHTarget Corporation6ba2761c-4c05-498b-a012-e95843c205732024-11-21WarningsExact identifier
application number: M016
Target Baby HealingPETROLATUMTarget Corporation5a445a96-1652-47e0-b9bb-6e63fc1841082024-11-21WarningsExact identifier
application number: M016
Target Vitamin A and D Diaper RashVITAMIN A AND D OINTMENTTarget Corporation6a98e4b9-2906-4207-83ac-48f41fba190e2024-11-21WarningsExact identifier
application number: M016
Walgreens Baby HealingPETROLATUMWalgreens Company54100d5a-7ae1-45ec-94c4-e165b55a6c492024-11-20WarningsExact identifier
application number: M016
Baby Petroleum JellyWHITE PETROLATUM JELLYWALGREENS2008da4f-3c3c-4311-e063-6394a90a81e72024-11-20WarningsExact identifier
application number: M016
Vitamins A and D Without LanolinSKIN PROTECTANTDynarex Corporation822db5f4-d662-0689-e053-2a91aa0ace7e2024-11-20WarningsExact 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