FDA.reportPublic FDA data

Denorex Extra Strength with Conditioner

Manufacturer
Neoteric Cosmetics, Inc.
Effective date
2026-04-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:52:42

Label at a glance#

ProductDenorex Extra Strength
Active ingredientSALICYLIC ACID
Label structure11 sections

Indications and uses

Reduces and helps prevent recurrence of these symptoms of dandruff, seborrheic dermatitis and psoriasis. • scalp irritation and itching • flaking • scaling

Dosage and administration

for best results, use at least twice a week or as directed by a doctor. shake well before use. • apply to wet hair. massage into scalp, leave lather on for several minutes. rinse thoroughly and repeat for maximum relief.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 3%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Uses

INDICATIONS & USAGE SECTION

Reduces and helps prevent recurrence of these symptoms of dandruff, seborrheic dermatitis and psoriasis.

• scalp irritation and itching • flaking • scaling

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 body.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

SPL UNCLASSIFIED SECTION

If 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

  • for best results, use at least twice a week or as directed by a doctor.
  • shake well before use. • apply to wet hair.
  • massage into scalp, leave lather on for several minutes.
  • rinse thoroughly and repeat for maximum relief.

Other information

SPL UNCLASSIFIED SECTION

Store at 68-77° F (20-25° C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua\Water\Eau, Sodium C14-16 olefin sulfonate, PPG-2 Hydroxyethyl Cocamide, Propylene glycol, Glycol distearate, Menthol, Cocamidopropyl betaine, Fragrance\Parfum, Panthenol, Tocopheryl acetate, Glycerin, Dimethicone PEG-8 Meadowfoamate, Polyquaternium-10, Sodium chloride, Sodium citrate, Sodium hydroxide, CI 15985 (Yellow 6), CI 47005 (Yellow 10), CI 17200 (Red 33), CI 42090 (Blue 1)

Questions?

OTC - QUESTIONS SECTION

Call 1-888-398-1382

email info@denorex.com or visit www.denorex.com

SPL UNCLASSIFIED SECTION

EXTRA STRENGTH

Denorex®

MULTI-SYMPTOM

MEDICATED ANTI-DANDRUFF

SHAMPOO + CONDITIONER

DISTRIBUTED BY NEOTERIC COSMETICS, INC.

NEW YORK 10003 / MADE IN USA

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

Denorex®

MULTI-SYMPTOM

MEDICATED

ANTI-DANDRUFF

SHAMPOO + CONDITIONER

SALICYLIC ACID 3% / DANDRUFF, SEBORRHEIC DEMATITIS + PSORIASIS

EFFECTIVE RELIEF OF 6 DANDRUFF SYMPTOMS

FLAKING & SCALING

DRYNESS

SCALP BUILDUP

IRRITATION

ITCHING

REDNESS

associated with dandruff, seborrheic dermatitis + psoriasis

3% SALICYLIC ACID

10 FL OZ. (296 ml)

LABELLABEL

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62673-059-102024-12-18C16284748780-1e4f33bdf-a537-d8a0-e053-dadaa90a6e4eDenorex Extra Strength with Conditioner
62673-059-102022-07-29C16284748780-1e4f33bdf-a537-d8a0-e053-dadaa90a6e4eDenorex Extra Strength with Conditioner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62673-059-10Denorex Extra Strength296 mL in 1 BOTTLESHAMPOO2964

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62673-05962673-059-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
DIMETHICONE PEG-8 MEADOWFOAMATE53UN5B8F4WIACT
MENTHOLL7T10EIP3AIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCOL DISTEARATE13W7MDN21WIACT
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
GLYCERINPDC6A3C0OXIACT
POLYQUATERNIUM-10 (10000 MPA.S AT 2%)PI1STR9QYHIACT
PPG-2 HYDROXYETHYL COCAMIDE34N07GUJ3XIACT

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
Denorex Extra StrengthSALICYLIC ACIDNeoteric Cosmetics, Inc.21d234ff-f379-4bcd-9ba0-90f27c6d3a692026-04-01WarningsExact identifier
ndc (package): 62673-059-10
ndc (product): 62673-059
ndc11 (package): 62673005910
spl id: 4ed2043a-0f5e-a764-e063-6394a90aa3bd
spl set id: 21d234ff-f379-4bcd-9ba0-90f27c6d3a69

Reported adverse events (FAERS/openFDA)#

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