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Nizoral

Ketoconazole · Shampoo

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Nizoral
Generic name
Ketoconazole
Dosage form
Shampoo
Route
Topical
Marketing category
NDA · NDA
Labeler
Kramer Laboratories
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
3
Packages
11
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ketoconazole 1 g/100mL 197853 View
Ketoconazole 10 mg/mL 197853 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Shampoo
Route of administration
Topical
Presentations
14

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Azole Antifungal [EPC] EPC All 44 members
Azoles [CS] CS All 44 members
Cytochrome P450 3A4 Inhibitors [MoA] MoA All 118 members
Cytochrome P450 3A5 Inhibitors [MoA] MoA 7 members — no class page
P-Glycoprotein Inhibitors [MoA] MoA All 105 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020310
Application type
NDA · New Drug Application
Approval date
October 10, 1997
Sponsor
KRAMER
Products on application
1
Submissions recorded
27
Products approved under application 020310.
Product Trade name Form Strength Ingredient Status TE Flags
020310-001 NIZORAL ANTI-DANDRUFF SHAMPOO KETOCONAZOLE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020310.
Type No. Action Status Date Review
Supplement 42 Manufacturing (CMC) Approved April 30, 2026 N/A
Supplement 41 Labeling Approved November 18, 2025 Standard
Supplement 34 Manufacturing (CMC) Approved January 26, 2025 N/A
Supplement 33 Manufacturing (CMC) Approved July 5, 2024 N/A
Supplement 32 Manufacturing (CMC) Approved March 14, 2024 N/A
Supplement 31 Manufacturing (CMC) Approved September 29, 2023 N/A
Supplement 29 Manufacturing (CMC) Approved January 19, 2023 N/A
Supplement 27 Manufacturing (CMC) Approved May 13, 2022 N/A
Supplement 26 Labeling Approved February 2, 2021 Standard
Supplement 24 Labeling Approved April 20, 2020 Standard
Supplement 23 Labeling Approved November 25, 2019 Standard
Supplement 22 Manufacturing (CMC) Approved November 30, 2018 N/A
Supplement 21 Manufacturing (CMC) Approved January 3, 2014 Standard
Supplement 20 Manufacturing (CMC) Approved September 5, 2013 Standard
Supplement 19 Manufacturing (CMC) Approved September 17, 2010 Standard
Supplement 13 Manufacturing (CMC) Approved March 8, 2002 Standard
Supplement 11 Manufacturing (CMC) Approved July 13, 2001 Standard
Supplement 10 Manufacturing (CMC) Approved August 11, 2000 Standard
Supplement 9 Manufacturing (CMC) Approved January 21, 2000 Standard
Supplement 7 Manufacturing (CMC) Approved January 13, 1999 Standard
Supplement 6 Manufacturing (CMC) Approved January 13, 1999 Standard
Supplement 8 Manufacturing (CMC) Approved December 22, 1998 Standard
Supplement 5 Manufacturing (CMC) Approved November 17, 1998 Standard
Supplement 4 Manufacturing (CMC) Approved November 6, 1998 Standard
Supplement 3 Manufacturing (CMC) Approved November 6, 1998 Standard
Supplement 2 Manufacturing (CMC) Approved November 6, 1998 Standard
Original application 1 Type 3 - New Dosage Form Approved October 10, 1997 Standard

Review documents

  • 0 · Supplement · May 4, 2026
  • 0 · Supplement · May 4, 2026
  • 0 · Supplement · November 19, 2025
  • 0 · Supplement · November 19, 2025
  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · July 8, 2024
  • 0 · Supplement · July 8, 2024
  • 0 · Supplement · March 15, 2024
  • 0 · Supplement · March 15, 2024
  • 0 · Supplement · October 3, 2023
  • 0 · Supplement · October 3, 2023
  • 0 · Supplement · January 20, 2023
  • 0 · Supplement · January 20, 2023
  • 0 · Supplement · May 19, 2022
  • 0 · Supplement · May 16, 2022
  • 0 · Supplement · February 3, 2021
  • 0 · Supplement · April 21, 2020
  • 0 · Supplement · April 21, 2020
  • 0 · Supplement · November 27, 2019
  • 0 · Supplement · November 27, 2019
  • 0 · Supplement · December 4, 2018
  • 0 · Original application · February 7, 2014
  • 0 · Supplement · September 21, 2010
  • 0 · Original application · October 10, 1997

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250711). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250711

Indications and Usage

openFDA Drug Labeling

Uses controls flaking, scaling and itching associated with dandruff

Purpose

openFDA Drug Labeling

Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo

Dosage and Administration

openFDA Drug Labeling

Directions 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

Warnings

openFDA Drug Labeling

Warnings For external use only

Do Not Use

openFDA Drug Labeling

Do not use on scalp that is broken or inflamed if you are allergic to ingredients in this product

Ask a Doctor

openFDA Drug Labeling

Stop use and ask a doctor if rash appears condition worsens or does not improve in 2-4 weeks

Active Ingredient

openFDA Drug Labeling

Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo

Adverse event reports

Source: openFDA FAERS
17,282
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: KETOCONAZOLE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
55505-196-33 55505-196 Kramer Laboratories 1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE June 16, 2022
55505-196-40 55505-196 Kramer Laboratories 1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE June 16, 2022
55505-196-47 55505-196 Kramer Laboratories 4 mL in 1 PACKET (55505-196-47) March 1, 2024
55505-196-57 55505-196 Kramer Laboratories 2 BOTTLE in 1 CARTON (55505-196-57) / 200 mL in 1 BOTTLE April 29, 2023
55505-196-65 55505-196 Kramer Laboratories 1 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTON June 16, 2022
55505-196-68 55505-196 Kramer Laboratories 3 BOTTLE in 1 CARTON (55505-196-68) / 200 mL in 1 BOTTLE October 15, 2022
55505-196-72 55505-196 Kramer Laboratories 2 BOTTLE in 1 CARTON (55505-196-72) / 325 mL in 1 BOTTLE December 1, 2023
55505-196-84 55505-196 Kramer Laboratories 2 BOTTLE in 1 CARTON (55505-196-84) / 400 mL in 1 BOTTLE June 1, 2025
55505-196-85 55505-196 Kramer Laboratories 1 BOTTLE in 1 CARTON (55505-196-85) / 562 mL in 1 BOTTLE January 12, 2026
55505-232-65 55505-232 Kramer Laboratories 400 mL in 1 CARTON (55505-232-65) October 1, 2025
55505-233-65 55505-233 Kramer Laboratories 400 mL in 1 CARTON (55505-233-65) November 1, 2024
55505-196 55505-196 Kramer Laboratories — June 16, 2022
55505-232 55505-232 Kramer Laboratories — October 1, 2025
55505-233 55505-233 Kramer Laboratories — November 1, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.