FDA.reportPublic FDA data

Nizoral

Manufacturer
Kramer Laboratories
Effective date
2025-08-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:11:34

Label at a glance#

ProductNizoral
Active ingredientKetoconazole
Label structure13 sections

Dosage and administration

adults and children 12 years and over wet hair thoroughly apply shampoo, generously lather, rinse thoroughly. Repeat use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff children under 12 years ask a doctor

Storage and handling

store at 20°C to 25°C (68°F-77°F) see top panel for lot number and expiration date

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Ketoconazole 1% w/wAnti-dandruff shampoo

INDICATIONS & USAGE SECTION

Uses 
controls flaking, scaling and itching associated with dandruff

WARNINGS SECTION

Warnings
For external use only

Do not use

OTC - DO NOT USE SECTION

  • on scalp that is broken or inflamed
  • if you are allergic to ingredients in this product

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • if product gets into eyes, rinse thoroughly with water

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • rash appears
  • condition worsens or does not improve in 2-4 weeks

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children
12 years and over
  • wet hair thoroughly
  • apply shampoo, generously lather,
    rinse thoroughly. Repeat
  • use every 3-4 days for up to 8 weeks
    or as directed by a doctor. Then use
    only as needed to control dandruff
children under
12 years
  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20°C to 25°C (68°F-77°F)
  • see top panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium laureth sulfate, sodium cocoyl sarcosinate, cocamide MEA, glycol distearate, benzyl alcohol, hydroxypropyl methylcellulose, polyquaternium-7, tetrasodium EDTA, fragrance, sodium chloride, BHT, citric acid, sodium benzoate, hydrochloric acid, sodium hydroxide, blue 1

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-824-4894

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Shampoo + conditioner

Nizoral®

Anti-Dandruff

KETOCONAZOLE 1%
ANTI-DANDRUFF SHAMPOO 

2-IN-1
Anti Drandruff
Shampoo +
Conditioner

CLINICALLY PROVEN
to control flaking, scaling and
itching from dandruff

CONTROLS
fungus that can cause dandruff

CONDITIONS
leaves hair soft, smooth & manageable

14 fl oz (400mL)

What Causes
Dandruff?
Dandruff can have many
causes. A fungus found on
every human head is often
associated with dandruff.

How Does Nizoral® 
Anti-Dandruff Work?
NIZORAL® Anti-Dandruff is
the only over-the-counter
anti-dandruff shampoo
that has Ketoconazole,
an effective antifungal.
Ketoconazole works by
controlling fungus often
associated with dandruff,
and once the fungus is
controlled, so are your
dandruff symptoms.

Nizoral ®
Anti-Dandruff
KETOCONAZOLE 1%
ANTI-DANDRUFF SHAMPOO 

Nizoral®  2-IN-1
Anti-Dandruff
Shampoo +
Conditioner
is formulated with more
conditioning properties
to help leave hair soft,
smooth, and manageable.

KRAMER
LABORATORIES

Made in Canada
Distributed by:
Kramer Laboratories, Inc.
Bridgewater, NJ 08807 USA

© 2025 KRAMER
LABORATORIES, INC.

Before use, read all label
information. If you have a
drug reaction, contact a
doctor and report it by calling:
1.800.824.4894

P238B15000

Lot:

Exp:         YYYY-MM

K0524

400mL Carton
400mL Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240812ketoconazole 1 % Medicated ShampooPSN2
608844Nizoral A-D 1 % Medicated ShampooPSN2
608844ketoconazole 10 MG/ML Medicated Shampoo [Nizoral]SBD2
240812ketoconazole 10 MG/ML Medicated ShampooSCD2
240812ketoconazole 1 % Medicated ShampooSY2
608844Nizoral 1 % Medicated ShampooSY2
608844Nizoral 10 MG/ML Medicated ShampooSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-233-65Nizoral400 mL in 1 CARTONSHAMPOO4002

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55505-23355505-233-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
KetoconazoleR9400W927IACTIB
Benzyl AlcoholLKG8494WBHIACT
Butylated Hydroxytoluene1P9D0Z171KIACT
Fd&C Blue No. 1H3R47K3TBDIACT
Citric Acid Monohydrate2968PHW8QPIACT
Coco MonoethanolamideC80684146DIACT
Glycol Distearate13W7MDN21WIACT
Hydrochloric AcidQTT17582CBIACT
Hypromellose, Unspecified3NXW29V3WOIACT
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw)0L414VCS5YIACT
Sodium Chloride451W47IQ8XIACT
Sodium Cocoyl Sarcosinate1R9DUY89CZIACT
Sodium Hydroxide55X04QC32IIACT
Sodium Laureth-3 SulfateBPV390UAP0IACT
Edetate SodiumMP1J8420LUIACT
Water059QF0KO0RIACT
Sodium BenzoateOJ245FE5EUIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020310-001NIZORAL ANTI-DANDRUFFKETOCONAZOLE1%SHAMPOO / TOPICALRLD, RS1997-10-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10c2088c7a36db…
2026-09-14 22:38:342026-08N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-1084e616aacf4f…
2026-08-18 06:07:402026-07N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-103f01610625f2…
2019-09-15 20:21 UTC2019-09N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-103f0d92c62455…
2023-05-13 08:27 UTC2023-05N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10053a50430f4f…
2023-01-26 05:58 UTC2023-01N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-103a93d1ddd44b…

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
NizoralKETOCONAZOLEKramer Laboratoriesf5c8c5b4-49bd-4dc7-8c29-8f1317c6ef882025-08-21WarningsExact identifier
ndc (package): 55505-233-65
ndc (product): 55505-233
ndc11 (package): 55505023365
spl id: d92aa7b7-48b6-4db5-9db4-85f4f4dd563d
spl set id: f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88

Reported adverse events (FAERS/openFDA)#

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