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

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
Balancing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC1 g/100mL

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
209884Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
984780fd-4969-150b-e053-2995a90aed77Available on FDA.report

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

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 9 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DandruffPYRITHIONE ZINC 1%Meijer, Inc.28525947-97f6-4b3f-b8bd-596ffcf611882026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Dry ScalpPYRITHIONS ZINCMeijer, Inc.57a944af-397f-41d9-bfe0-7cac0dd26cb12026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCMeijer, Inc.9ca4dd70-3dca-4d5a-a13d-51a5dbf92af02026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders Hydrating Coconut KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b33d7cd-93ae-6ec9-e063-6294a90afc632026-02-19WarningsExact identifier
application number: M032
DandruffSELENIUM SULFIDEMeijer, Inc.c0e4f8cb-74fc-4c0d-9721-f87aa2aa19922026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Selsun Blue Naturals Itchy, Dry ScalpSALICYLIC ACIDChattem, Inc.ed031a0f-7467-4b2c-a6b6-95306f6ee8282026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Hydrating Coconut 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b1a4f24-ff9b-9677-e063-6294a90a9c222026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Coconut 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7cc1c6c8-27cd-6d9e-e053-2991aa0a99df2026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Tea Tree Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company96b37f23-230f-0652-e053-2a95a90a1f642026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Sensitive Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company38921198-56d3-ab01-e063-6394a90a89b92026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Smooth and Silky 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb592026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Hydrating CoconutPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b20caa0-9ec6-3bfc-e063-6294a90ac68e2026-02-18WarningsExact identifier
application number: M032
Selsun Blue 2-in-1SELENIUM SULFIDEChattem, Inc.f97e458c-cce3-498f-81fc-1b96a4e8f50a2026-02-18WarningsExact identifier
application number: M032
Selsun Blue Itchy Dry ScalpPYRITHIONE ZINCChattem, Inc.c491014d-f8c7-46bb-b065-eaf5ea8428602026-02-18WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFI77b2e0da-a6d7-42b5-92af-4e7979817b782026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFI064ff929-d965-4b1a-98a9-f2779f346d7f2026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFId7c4507e-7f74-4bcd-9b0e-0b097193a1a82026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFIecc20b71-eb6b-43ed-86bc-32d61641ee3a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCTKC Holdings, Inc.c3bc9a89-b1f3-4b7a-bebb-00c341956d602026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCValu Merchandisers Companybb0a74e0-2312-4444-b7e1-19a9a3a7007e2026-02-16Warnings, Adverse reactionsExact identifier
application number: M032

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 ml2025-01-01NoNoCurrent