FDA.reportPublic FDA data

HEAD AND SHOULDERS OLD SPICE

Manufacturer
ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. | PROCTER & GAMBLE MANUFACTURING MEXICO, S. DE R.L. DE C.V.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:54

Label at a glance#

ProductHEAD AND SHOULDERS OLD SPICE
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

With Regular use, H&S 3action formula cleans, protects and hydrates hair and scalf.

The DermaSense balanced pH formula, eliminates up to 100% of dandruff trace*, takes care of your scalp and leaves your hair

beautiful,

*Visible dandruff, using it often.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient................................................................................Purpose

Pyrithione Zinc 1%.....................................................................Anti-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 thoroughly with water

Stop use and ask doctor if

OTC - STOP USE SECTION

condition worsens or does not improve after regular use as directed

Keep our 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 before use - apply in wet hair - massage into scalp - rinse

-repeat as desired

-for best results use at least twice a week or as directed by a doctor

-for maximum dandruff control, use every time you shampoo

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate,

dimethicone, zinc carbonate, sodium chloride, sodium xylenesulfonate,

cocamidopropyl betaine, parfum, sodium benzoate, guar

hydroxypropyltrimonium chloride, hydrochloric acid, hexyl cinnamal,

linalool, magnesium carbonate hydroxide, methylchloroisothiazolinone,

FD&C Blue 1, methylisothiaolinone, D&C Red.33

Distributed by:

OTC - QUESTIONS SECTION

ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.

Made in Mexico

Indications:

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff

HEAD & SHOULDERS Antidandruff Shampoo 2 in 1 Soft and Manageable

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Old Spice LabelOld Spice Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN3
209884zinc pyrithione 1 % Medicated ShampooPSN3
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD3
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD3
1043244Head & Shoulders 1 % Medicated ShampooSY3
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY3
209884zinc pyrithione 1 % Medicated ConditionerSY3
209884zinc pyrithione 1 % Medicated ShampooSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72389-102-012024-01-30C16284748780-19d75b9d0-e782-f424-e053-dadaa90a57ceHead and Shoulders Old Spice
72389-102-022024-01-30C16284748780-19d75b9d0-e782-f424-e053-dadaa90a57ceHead and Shoulders Old Spice
72389-102-032024-01-30C16284748780-19d75b9d0-e782-f424-e053-dadaa90a57ceHead and Shoulders Old Spice
72389-102-012022-01-14C16284748780-19d75b9d0-e782-f424-e053-dadaa90a57ceHead and Shoulders Old Spice
72389-102-022022-01-14C16284748780-19d75b9d0-e782-f424-e053-dadaa90a57ceHead and Shoulders Old Spice
72389-102-032022-01-14C16284748780-19d75b9d0-e782-f424-e053-dadaa90a57ceHead and Shoulders Old Spice
72389-102-012020-01-31C16284748780-19d75b9d0-e782-f424-e053-dadaa90a57ceHead and Shoulders Old Spice
72389-102-022020-01-31C16284748780-19d75b9d0-e782-f424-e053-dadaa90a57ceHead and Shoulders Old Spice
72389-102-032020-01-31C16284748780-19d75b9d0-e782-f424-e053-dadaa90a57ceHead and Shoulders Old Spice

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72389-102-01HEAD AND SHOULDERS OLD SPICE1000 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO10003
72389-102-02HEAD AND SHOULDERS OLD SPICE375 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO3753
72389-102-03HEAD AND SHOULDERS OLD SPICE180 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72389-102HEAD AND SHOULDERS OLD SPICE (HEAD AND SHOULDERS) LOTION/SHAMPOO [ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.]3Legacy NDC, 3 package rows20220115_6fa9bf6a-bccc-7f37-e053-2991aa0a5299.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72389-10272389-102-01, 72389-102-02, 72389-102-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIMONENE, (+)-GFD7C86Q1WIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
GLYCOL DISTEARATE13W7MDN21WIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
LINALOOL, (-)-3U21E3V8I2IACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
LAURIC MONOETHANOLAMIDE098P2IGT76IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
HYDROCHLORIC ACIDQTT17582CBIACT
ZINC CARBONATEEQR32Y7H0MIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
CETYL ALCOHOL936JST6JCNIACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d59288ac-cf66-e1f8-e053-2a95a90a9e6c6fa9bf6a-bccc-7f37-e053-2991aa0a52992022-01-14WarningsExact identifier
spl id: d59288ac-cf66-e1f8-e053-2a95a90a9e6c
spl set id: 6fa9bf6a-bccc-7f37-e053-2991aa0a5299

Reported adverse events (FAERS/openFDA)#

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