FDA.reportPublic FDA data

ANTIDANDRUFF

Manufacturer
SAFEWAY INC
Effective date
2010-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:27

Label at a glance#

ProductANTIDANDRUFF MEDICATED
Active ingredientSELENIUM SULFIDE
Label structure5 sections

Indications and uses

USES: FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RE-OCCURRENCE. DIRECTIONS: SHAKE WELL, SHAMPOO, THEN RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

Dosage and administration

USES: FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RE-OCCURRENCE. DIRECTIONS: SHAKE WELL, SHAMPOO, THEN RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

SELENIUM SULFIDE 1% (ANTI DANDRUFF)

USES AND DIRECTIONS

OTC - PURPOSE SECTION

  • USES: FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RE-OCCURRENCE.
  • DIRECTIONS:SHAKE WELL, SHAMPOO, THEN RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY.

ASK A DOCTOR BEFORE USING IF YOU HAVE

OTC - ASK DOCTOR SECTION

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR-TREATED OR PERMED HAIR, RINSE THOROUGHLY.

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.

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.

PACKAGE FRONT AND BACK LABELS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11OZ FRONT AND BACK LABELS: safeway11.jpg11 OZ FRONT AND BACK LABELS11 OZ FRONT AND BACK LABELS

QUESTIONS/COMMENTS?

OTC - QUESTIONS SECTION

1 - 888 - SAFEWAY

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204642selenium sulfide 1 % Medicated ShampooPSN1
204642selenium sulfide 10 MG/ML Medicated ShampooSCD1
204642selenium sulfide 1 % Lotion ShampooSY1
204642selenium sulfide 1 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-610-112020-01-31C16284748780-19d75b9d0-8a9a-f424-e053-dadaa90a57ceDrug Facts Box - Back Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-610-11ANTIDANDRUFF MEDICATED325 mL in 1 BOTTLE, PLASTICSHAMPOO3251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-610ANTIDANDRUFF (SELENIUM SULFIDE) SHAMPOO [SAFEWAY INC]1Legacy NDC, 1 package rows20100806_69023442-44d5-4ffe-a5d7-263c02c4dbbe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SELENIUM SULFIDEACTIVE INGREDIENTZ69D9E381Q1
SELENIUMACTIVE MOIETYH6241UJ22B1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-61021130-610-11

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SELENIUM SULFIDEZ69D9E381QACTIB

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
31e65e9d-35da-4899-91bf-e95e2bd2a8ec69023442-44d5-4ffe-a5d7-263c02c4dbbe2010-08-05WarningsExact identifier
spl id: 31e65e9d-35da-4899-91bf-e95e2bd2a8ec
spl set id: 69023442-44d5-4ffe-a5d7-263c02c4dbbe

Reported adverse events (FAERS/openFDA)#

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