FDA.reportPublic FDA data

Head and Shoulders Dry Scalp Care Dual Pack

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:48

Label at a glance#

ProductHead and Shoulders Dry Scalp Care Dual Pack
Active ingredientPYRITHIONE ZINC
Label structure18 sections

Indications and uses

helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SHAMPOO

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

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

  • avoid contact with 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 of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, sodium xylenesulfonate, zinc carbonate, glycol distearate, fragrance, sodium chloride, dimethiconol, sodium benzoate, guar hydroxypropyltrimonium chloride, dimethicone, TEA-dodecylbenzenesulfonate, magnesium carbonate hydroxide, trideceth-10, prunus amygdalus dulcis (sweet almond) oil, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

CONDITIONER

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.5%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

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

  • avoid contact with 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 of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • for best results use at least twice a week or as directed by a doctor.
  • apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, glutamic acid, dimethicone, fragrance, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head & shoulders ®

Shampoo & Conditioner Inside

head & shoulders

pyrithione zinc dandruff shampoo

DRY SCALP CARE

DAILY SHAMPOO

head & shoulders

pyrithione zinc dandruff conditioner

DRY SCALP CARE DAILY HAIR & SCALP

CONDITIONER

1 PYRITHIONE ZINC DANDRUFF

SHAMPOO 12.5 FL OZ (370 mL)

1 PYRITHIONE ZINC DANDRUFF

CONDITIONER 10.9 FL OZ (325 mL)

hshs

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044465head & shoulders 0.5 % Medicated ShampooPSN1
1043244head & shoulders 1 % Medicated ShampooPSN1
1043014zinc pyrithione 0.5 % Medicated ConditionerPSN1
209884zinc pyrithione 1 % Medicated ShampooPSN1
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD1
1044465zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]SBD1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
1043014zinc pyrithione 5 MG/ML Medicated ShampooSCD1
1044465Head & Shoulders 0.5 % ConditionerSY1
1043244Head & Shoulders 1 % Medicated ShampooSY1
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY1
1044465Head & Shoulders 5 MG/ML Medicated ShampooSY1
1043014zinc pyrithione 0.5 % Medicated ShampooSY1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-092-37Head and Shoulders Dry Scalp Care Dual Pack370 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO370 mL1 g in 100mL1
69423-160-32Head and Shoulders Dry Scalp Care Dual Pack325 mL in 1 TUBELOTION325 mL0.5 g in 100mL1
84126-077-01Head and Shoulders Dry Scalp Care Dual Pack1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-092HEAD AND SHOULDERS DRY SCALP CARE DUAL PACK (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, Legacy NDC20250309_2cdb1e94-3923-84f7-e063-6394a90a07d5.zip
69423-160HEAD AND SHOULDERS DRY SCALP CARE DUAL PACK (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, Legacy NDC20250309_2cdb1e94-3923-84f7-e063-6394a90a07d5.zip
84126-077HEAD AND SHOULDERS DRY SCALP CARE DUAL PACK (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 3 package rows20250309_2cdb1e94-3923-84f7-e063-6394a90a07d5.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-07784126-077-01
37000-09237000-092-37
69423-16069423-160-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONOL (50000 CST)R2285D73YTIACT
SODIUM BENZOATEOJ245FE5EUIACT
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL66YXD4DKO9IACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
ZINC CARBONATEEQR32Y7H0MIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEB16G315W7AIACT
TEA-DODECYLBENZENESULFONATE8HM7ZD48HNIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
BENZYL ALCOHOLLKG8494WBHIACT
GLYCOL DISTEARATE13W7MDN21WIACT
TRIDECETH-10G624N6MSBAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
DIMETHICONE92RU3N3Y1OIACT
CITRIC ACID2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL66YXD4DKO9IACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLUTAMIC ACID3KX376GY7LIACT

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Dry Scalp Care Hair and Scalp ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company42620236-17ef-5c70-e054-00144ff88e882025-12-18WarningsExact identifier
ndc (package): 69423-160-32
ndc (product): 69423-160
ndc11 (package): 69423016032
Head and Shoulders Dry Scalp Care Dual PackPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cdb1e94-3923-84f7-e063-6394a90a07d52025-01-29WarningsExact identifier
ndc (package): 37000-092-37
ndc (package): 84126-077-01
ndc (package): 69423-160-32
ndc (product): 84126-077
ndc11 (package): 37000009237
ndc11 (package): 84126007701
ndc11 (package): 69423016032
spl id: 2cdb1e94-3922-84f7-e063-6394a90a07d5
spl set id: 2cdb1e94-3923-84f7-e063-6394a90a07d5

Reported adverse events (FAERS/openFDA)#

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