FDA.reportPublic FDA data

Balancing

Product NDC
73528-110
11-digit product format
735280110
Labeler code
73528
Product ID
73528-110_4f9a51ba-aea7-081f-e063-6394a90a4122
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Zero Flakes Given, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-30
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
4f9a51ba-aea6-081f-e063-6394a90a4122Available 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
73528-110-01Balancing280 mL in 1 BOTTLE, DISPENSINGSHAMPOO2801
73528-110-02Balancing85 mL in 1 BOTTLE, DISPENSINGSHAMPOO851
73528-110-03Balancing9 mL in 1 PACKETSHAMPOO91
73528-110-04Balancing250 mL in 1 BOTTLE, DISPENSINGSHAMPOO2501
73528-110-05Balancing415 mL in 1 BOTTLE, DISPENSINGSHAMPOO4151

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 17 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaZincPYRITHIONE ZINCWynnPharm Ince73010ae-291d-6adf-e053-2a95a90a8aea2025-11-14WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Pure Sport Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7bbd2559-4aba-9f18-e053-2991aa0a152e2025-11-13WarningsExact identifier
application number: M032
Divine Dandrene 1%ZINC PYRITHIONEDS Healthcare Group, Inc.ab605699-4090-45a3-882f-44379fe2a82e2025-11-11WarningsExact identifier
application number: M032
Divine Dandrene 2%ZINC PYRITHIONEDS Healthcare Group, Inc.54b0a610-dd15-4064-9feb-4d30b5e522ad2025-11-11WarningsExact identifier
application number: M032
Dandrene Anti-Dandruff ConditionerZINC PYRITHIONEDS Healthcare Group, Inc.aed49bfe-e016-46ac-a025-81b47cc081472025-11-11WarningsExact identifier
application number: M032
Minoxidil hair growth serumMINOXIDIL HAIR GROWTH SERUMJiashen International Trade Limited26cc22be-30f6-03da-e063-6394a90aafe72025-11-09WarningsExact identifier
application number: M032
Sulfur 8 Kids Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.89f4ecc8-7a49-42cb-b85d-71c9299e67122025-11-07WarningsExact identifier
application number: M032
Sulfur 8 Aqua BluePYRITHIONE ZINCJ. Strickland & Co.cdcf3cea-4a5d-4b8b-b47d-3163f9837d162025-11-07WarningsExact identifier
application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff ControlPYRITHIONE ZINCJ. Strickland and Co.96b26da0-d0d7-77ed-e053-2995a90a7a782025-11-07WarningsExact identifier
application number: M032
Shailee Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd02a71ce4-baf5-4231-afd6-21ef0b22e9312025-11-05WarningsExact identifier
application number: M032
Sulfur 8 Kids Anti-Dandruff Hair and Scalp ConditionerSULFURJ. Strickland & Co.8e9da3fd-701e-4354-bb00-ecd4dab48fa32025-11-03WarningsExact identifier
application number: M032
Denorex Severe Flakes Medicated Anti DandruffPYRITHIONE ZINCNeoteric Cosmetics, Inc.41ad0d3a-0704-44c9-e063-6394a90ad40d2025-10-21WarningsExact identifier
application number: M032
Stay Minoxidil Hair Regrowth TreatmentMINOXIDIL 5%HALORIA INC.41b745d7-6947-ec24-e063-6294a90aa4672025-10-21WarningsExact identifier
application number: M032
DERMOSCRIBE SEBORRHEIC DERMATITISSULFUR, SALICYLIC ACID, HYDROCORTISONEDERMOSCRIBE PTY LTD2b6bf90b-5d42-4c08-afee-56e13122285e2025-10-17WarningsExact identifier
application number: M032
Shea MoistureAPPLE CIDER VINEGAR INSTANT SCALP REFRESH ANTI-DANDRUFF SPRAYConopco, Inc. d/b/a Unilever414ab8ec-165c-21f8-e063-6294a90adc4f2025-10-16WarningsExact identifier
application number: M032
Shea MoistureAPPLE CIDER VINEGAR ANTI-DANDRUFF LEAVE-INConopco, Inc. d/b/a Unilever414b7fd2-6a65-af39-e063-6394a90a00b82025-10-16WarningsExact identifier
application number: M032
Seacall Natural Cedarwood OilNATURAL CEDARWOOD OILGuangdong Quadrant Ecological Technology Co., Ltd.1f4ebe4d-6e93-378c-e063-6394a90aec952025-10-15WarningsExact identifier
application number: M032
RemedyDandruffShampooTreatmentACTIIV REMEDY DANDRUFF SHAMPOO TREATMENTNaturich Cosmetique Labs129fd043-6643-cc46-e063-6294a90a6eae2025-10-08WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company40464e2d-f738-33ec-e063-6394a90a02c22025-10-03WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company4046c345-e1ac-0ecc-e063-6294a90a59fa2025-10-03WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN4f9a51ba-aea6-081f-e063-6394a90a41221
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD4f9a51ba-aea6-081f-e063-6394a90a41221
209884zinc pyrithione 1 % Medicated ConditionerSY4f9a51ba-aea6-081f-e063-6394a90a41221
209884zinc pyrithione 1 % Medicated ShampooSY4f9a51ba-aea6-081f-e063-6394a90a41221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73528-110-0173528011001280 mL in 1 BOTTLE, DISPENSING (73528-110-01) 280 ml2026-04-30NoNoCurrent
73528-110-027352801100285 mL in 1 BOTTLE, DISPENSING (73528-110-02) 85 ml2026-04-30NoNoCurrent
73528-110-03735280110039 mL in 1 PACKET (73528-110-03) 9 ml2026-04-30NoNoCurrent
73528-110-0473528011004250 mL in 1 BOTTLE, DISPENSING (73528-110-04) 250 ml2026-04-30NoNoCurrent
73528-110-0573528011005415 mL in 1 BOTTLE, DISPENSING (73528-110-05) 415 ml2026-04-30NoNoCurrent