FDA.reportPublic FDA data

Restoring

Product NDC
73528-410
11-digit product format
735280410
Labeler code
73528
Product ID
73528-410_4f9934e4-ec38-9f68-e063-6394a90ab9a4
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
LIQUID
Route
TOPICAL
Labeler
Zero Flakes Given, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-30
Substance
PYRITHIONE ZINC
Active strength
.125 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Restoring
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC.125 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR953O2RHZ5
Rxcui2741467

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73528-410-01Restoring100 mL in 1 TUBELIQUID1001
73528-410-02Restoring30 mL in 1 TUBELIQUID301
73528-410-03Restoring5 mL in 1 PACKETLIQUID51
73528-410-04Restoring60 mL in 1 TUBELIQUID601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741467zinc pyrithione 0.125 % Topical SolutionPSN4f9934e4-ec37-9f68-e063-6394a90ab9a41
2741467zinc pyrithione 1.25 MG/ML Topical SolutionSCD4f9934e4-ec37-9f68-e063-6394a90ab9a41
2741467zinc pyrithione 0.125 % Topical SolutionSY4f9934e4-ec37-9f68-e063-6394a90ab9a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73528-410-0173528041001100 mL in 1 TUBE (73528-410-01) 100 ml2026-04-30NoNoHistorical
73528-410-027352804100230 mL in 1 TUBE (73528-410-02) 30 ml2026-04-30NoNoHistorical
73528-410-03735280410035 mL in 1 PACKET (73528-410-03) 5 ml2026-04-30NoNoHistorical
73528-410-047352804100460 mL in 1 TUBE (73528-410-04) 60 ml2026-04-30NoNoHistorical