FDA.reportPublic FDA data

Market Basket 281.007/281AN

Manufacturer
Demoulas Super Markets, Inc | Nice-Pak Products, LLC
Effective date
2026-10-01
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
daily-update
Hydrated at
2026-10-06 02:03:17

Label at a glance#

ProductDandruff
Active ingredientPYRITHIONE ZINC
Label structure13 sections

Dosage and administration

shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor

Label contents#

Full prescribing information#

Claims

SPL UNCLASSIFIED SECTION

Multiple benefit formula to help:

  • Fight dry scalp
  • Calm itch
  • Relieve irritation
  • Prevent flakes
  • Reduce oiliness
  • Soothe and reduce redness
  • Leave hair healthy looking

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1 %

Purpose

OTC - PURPOSE SECTION

Anti-Dandruff

Use

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve after regular use as directed

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • for maximum dandruff control, use every time you shampoo
  • wet hair, massage onto scalp, rinse, repeat if desired
  • for best results use at least twice a week or as directed by a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

Dislcaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ® Dry Scalp Care Dandruff Shampoo.

Adverse reactions

ADVERSE REACTIONS SECTION

Manufactured by

Nice-Pak Products, LLC

St. Louis, MO 63114 for

Demoulas Super Markets, Inc.

Tewksbury, MA 01876

1-888-593-0593

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

"MORE FOR YOUR DOLLAR"

MARKET BASKET ®

Compare to Head & Shoulders ®Dry Scalp Care*

Dandruff

Shampoo

pyrithione zinc

dry scalp

Plus Moisturizers and Added Almond Oil

Moisture balancing for dry scalp relief

Helps prevent flakes

12.5 FL OZ (370 mL)

image descriptionimage descriptionimage descriptionimage description

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ52
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ52
ALMOND OILINACTIVE INGREDIENT66YXD4DKO92
AMODIMETHICONE (800 CST)INACTIVE INGREDIENT363Z2T48P72
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX2
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21W2
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7A2
MAGNESIUM CARBONATE HYDROXIDEINACTIVE INGREDIENTYQO029V1L42
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP02
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950UR2
WATERINACTIVE INGREDIENT059QF0KO0R2
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0M2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53942-28153942-281-15, 53942-281-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
AMODIMETHICONE (800 CST)363Z2T48P7IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALMOND OIL66YXD4DKO9IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122026-02-03full-release2026-06-01 01:36:30
112025-11-14monthly-update2026-06-03 17:40:00

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 33 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii+route
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ZINC CARBONATEZINC CARBONATEEQR32Y7H0MINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS1.6 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ZINC CARBONATEZINC CARBONATEEQR32Y7H0MINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS1.6 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
15 equally ranked IID candidates
ZINC CARBONATEZINC CARBONATEEQR32Y7H0MINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS1.6 mgExact identifier — unii candidate
3 equally ranked IID candidates
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii+route
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii+route
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
49ef567f-c2f2-52c4-e063-6294a90a4502584df95a-7fc7-4b4b-b703-c423248444ed2026-02-03Warnings, Adverse reactionsExact identifier
spl set id: 584df95a-7fc7-4b4b-b703-c423248444ed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.