Drugplain

ADAPALENE AND BENZOYL PEROXIDE 3 mg/g

adapalene and benzoyl peroxide topical · GEL · Alembic Pharmaceuticals Limited

1 Recall on Record
Plain English

ADAPALENE AND BENZOYL PEROXIDE is a gel containing adapalene and benzoyl peroxide topical at 3 mg/g, taken topical. Manufactured by Alembic Pharmaceuticals Limited.

Key Facts

Brand Name
ADAPALENE AND BENZOYL PEROXIDE
Generic Name
adapalene and benzoyl peroxide topical
NDC Code (Product)
46708-662
Manufacturer
Alembic Pharmaceuticals Limited
Strength
3 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
ANDA214185
Drug Class
Retinoid [EPC]
Marketing Start
05/21/2025

Recall History

1 Recall on Record
Class II02/12/2024

MCKESSON CORPORATION

CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective10 reports
rash8 reports
acne5 reports
application site pain4 reports
erythema4 reports
application site erythema3 reports
application site pruritus3 reports
burning sensation3 reports
skin burning sensation3 reports
application site irritation2 reports

Frequently Asked Questions

What is ADAPALENE AND BENZOYL PEROXIDE used for?

ADAPALENE AND BENZOYL PEROXIDE contains adapalene and benzoyl peroxide topical. It is a gel taken topical. Consult your doctor for specific uses.

Is ADAPALENE AND BENZOYL PEROXIDE a controlled substance?

ADAPALENE AND BENZOYL PEROXIDE is not classified as a controlled substance by the DEA.

What is the generic name for ADAPALENE AND BENZOYL PEROXIDE?

The generic name for ADAPALENE AND BENZOYL PEROXIDE is adapalene and benzoyl peroxide topical. There are no other listed brand versions of adapalene and benzoyl peroxide topical.

What is the NDC code for ADAPALENE AND BENZOYL PEROXIDE 3 mg/g?

The NDC (National Drug Code) for ADAPALENE AND BENZOYL PEROXIDE 3 mg/g is 46708-662, listed by Alembic Pharmaceuticals Limited.

Product NDC

46708-662

Package NDC

46708-662-45

Other ADAPALENE AND BENZOYL PEROXIDE Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)