FDA.reportPublic FDA data

Denorex Extra Strength

Manufacturer
Humco Holding Group, Inc.
Effective date
2020-06-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:18:22

Label at a glance#

ProductDenorex Extra Strength
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis Helps prevent recurrence of the symptoms of dandruff, seborrheic dermatitis and psoriasis

Dosage and administration

Shake well apply to wet hair gently massage into hair and scalp to work up a lather rinse thoroughly and repeat for best results, use at least twice weekly or as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 3%

Purpose

OTC - PURPOSE SECTION

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

Uses

INDICATIONS & USAGE SECTION

  • Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis
  • Helps prevent recurrence of the symptoms of dandruff, seborrheic dermatitis and psoriasis

Warnings

WARNINGS SECTION

For external use only.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a condition that covers a large area of the body.

When using this product

OTC - WHEN USING SECTION

avoid contact with the 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.

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
  • apply to wet hair
  • gently massage into hair and scalp to work up a lather
  • rinse thoroughly and repeat
  • for best results, use at least twice weekly or as directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

Store at 20º-25º C (68º – 77º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cocamidopropyl betaine, D&C Red No. 33, D&C Yellow No. 10, dimethicone PEG-8 meadowfoamate, FD&C Blue No. 1, FD&C Yellow No. 6, fragrance, glycol distearate, menthol, panthenol, polyquaternium-10, PPG-2 hydroxyethyl cocamide, propylene glycol, sodium C14-C16 olefin sulfonate, sodium citrate, vitamin E acetate, water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Den0059.jpgDen0059.jpg

denorex-extra-strength-01.jpgdenorex-extra-strength-01.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1303358Denorex Extra Strength 3 % Medicated Shampoo, Reformulated Aug 2012PSN4
205023salicylic acid 3 % Medicated ShampooPSN4
1303358salicylic acid 30 MG/ML Medicated Shampoo [Denorex Extra Strength Reformulated Aug 2012]SBD4
205023salicylic acid 30 MG/ML Medicated ShampooSCD4
1303358Denorex Extra Strength 3 % Medicated Shampoo, Reformulated Aug 2012SY4
1303358Denorex Extra Strength Reformulated Aug 2012 30 MG/ML Medicated ShampooSY4
205023salicylic acid 3 % Medicated ShampooSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0395-0059-102022-07-29C16284748780-1e4f33bdf-a406-d8a0-e053-dadaa90a6e4eDenorex Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-0059-10Denorex Extra Strength296 mL in 1 BOTTLESHAMPOO2964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0059DENOREX EXTRA STRENGTH (SALICYLIC ACID) SHAMPOO [HUMCO HOLDING GROUP, INC.]4Legacy NDC, 1 package rows20200620_5d7f4d9c-2af3-4892-e053-2a91aa0a4327.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-00590395-0059-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCOL DISTEARATE13W7MDN21WIACT
MENTHOLL7T10EIP3AIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM CITRATE1Q73Q2JULRIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
a8716900-b4f4-d902-e053-2a95a90ae97c5d7f4d9c-2af3-4892-e053-2a91aa0a43272020-06-19WarningsExact identifier
spl id: a8716900-b4f4-d902-e053-2a95a90ae97c
spl set id: 5d7f4d9c-2af3-4892-e053-2a91aa0a4327

Reported adverse events (FAERS/openFDA)#

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