FDA.reportPublic FDA data

Balancing

Product NDC
73528-100
11-digit product format
735280100
Labeler code
73528
Product ID
73528-100_4f9888dc-9a18-e430-e063-6294a90a50f7
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Pyrithione
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Zero Flakes Given, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-01
Substance
PYRITHIONE ZINC
Active strength
1 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
Balancing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR953O2RHZ5
Rxcui209884

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73528-100-01Balancing280 mL in 1 BOTTLE, DISPENSINGSHAMPOO2809
73528-100-02Balancing85 mL in 1 BOTTLE, DISPENSINGSHAMPOO859
73528-100-03Balancing9 mL in 1 PACKETSHAMPOO99
73528-100-04Balancing250 mL in 1 BOTTLE, DISPENSINGSHAMPOO2509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73528-100BALANCING (ZINC PYRITHIONE) SHAMPOO [ZERO FLAKES GIVEN, LLC.]7Current NDC, Legacy NDC, 4 package rows20250128_984780fd-4969-150b-e053-2995a90aed77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN984780fd-4969-150b-e053-2995a90aed779
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD984780fd-4969-150b-e053-2995a90aed779
209884zinc pyrithione 1 % Medicated ConditionerSY984780fd-4969-150b-e053-2995a90aed779
209884zinc pyrithione 1 % Medicated ShampooSY984780fd-4969-150b-e053-2995a90aed779

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73528-100-0173528010001280 mL in 1 BOTTLE, DISPENSING (73528-100-01) 280 ml2020-02-010000-00-00NoNoCurrent
73528-100-027352801000285 mL in 1 BOTTLE, DISPENSING (73528-100-02) 85 ml2020-02-010000-00-00NoNoCurrent
73528-100-03735280100039 mL in 1 PACKET (73528-100-03) 9 ml2020-02-010000-00-00YesNoCurrent
73528-100-0473528010004250 mL in 1 BOTTLE, DISPENSING (73528-100-04) 250 ml2025-01-01NoNoHistorical