Drugplain

Dandruff 10 mg/mL

Pyrithione zinc · SHAMPOO · United Natural Foods, Inc. dba UNFI

6 Recalls on Record
Plain English

Dandruff is a shampoo containing pyrithione zinc at 10 mg/mL, taken topical. Manufactured by United Natural Foods, Inc. dba UNFI.

Key Facts

Brand Name
Dandruff
Generic Name
Pyrithione zinc
NDC Code (Product)
41163-253
Manufacturer
United Natural Foods, Inc. dba UNFI
Strength
10 mg/mL
Dosage Form
SHAMPOO
Route
TOPICAL
Marketing Status
Application #
M032
Marketing Start
01/21/2015

Recall History

6 Recalls on Record
Class III05/26/2016

Taro Pharmaceuticals U.S.A., Inc.

Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II10/09/2020

Milbar Laboratories, Inc.

GMP Deviations

TerminatedVoluntary: Firm initiated
Class III02/11/2016

J. Strickland and Co

Subpotent Drug: failed at the 3 and 6 month stability time points.

TerminatedVoluntary: Firm initiated
Class III12/09/2014

J. Strickland and Co

Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.

TerminatedVoluntary: Firm initiated
Class II06/03/2020

A.P. Deauville, LLC

cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,785 reports
off label use1,259 reports
fatigue1,237 reports
psoriasis1,170 reports
nausea1,116 reports
pruritus1,085 reports
pain1,063 reports
headache1,035 reports
rash918 reports
diarrhoea823 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use helps prevent recurrence of flaking and itching associated with dandruff.

Dosage & Administration

Directions shake well wet hair massage onto scalp rinse repeat if desired for best results use at least twice a week or as directed by a doctor for maximum dandruff control, use every time you shampoo

Warnings

Warnings For external use only When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Frequently Asked Questions

What is Dandruff used for?

Dandruff contains Pyrithione zinc. It is a shampoo taken topical. Consult your doctor for specific uses.

Is Dandruff a controlled substance?

Dandruff is not classified as a controlled substance by the DEA.

What is the generic name for Dandruff?

The generic name for Dandruff is Pyrithione zinc. There are 9 other brand versions of Pyrithione zinc.

What is the NDC code for Dandruff 10 mg/mL?

The NDC (National Drug Code) for Dandruff 10 mg/mL is 41163-253, listed by United Natural Foods, Inc. dba UNFI.