ORAL PAIN RELIEF 20 g/100g

Benzocaine · GEL · Nantong Health & Beyond Hygienic Products Inc.

1 Recall on Record

Plain English

ORAL PAIN RELIEF is a gel containing benzocaine at 20 g/100g, taken oral. Manufactured by Nantong Health & Beyond Hygienic Products Inc..

Key Facts

Brand Name: ORAL PAIN RELIEF
Generic Name: Benzocaine
NDC Code (Product): 43473-100
Manufacturer: Nantong Health & Beyond Hygienic Products Inc.
Strength: 20 g/100g
Dosage Form: GEL
Route: ORAL
Marketing Status
Application #: M022
Drug Class: Standardized Chemical Allergen [EPC]
Marketing Start: 01/20/2026

Recall History

1 Recall on Record

Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective177 reports

off label use150 reports

methaemoglobinaemia127 reports

dyspnoea125 reports

drug hypersensitivity119 reports

fatigue112 reports

pain105 reports

pruritus97 reports

headache95 reports

dizziness92 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infectionin minor oral irritation

Dosage & Administration

Directions ■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider ■ children under 12 years: should be supervised in the use of this product ■ children under 2 years of age: ask a physician or health care provider

Warnings

Warnings ■ Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

Frequently Asked Questions

What is ORAL PAIN RELIEF used for?

ORAL PAIN RELIEF contains Benzocaine. It is a gel taken oral. Consult your doctor for specific uses.

Is ORAL PAIN RELIEF a controlled substance?

ORAL PAIN RELIEF is not classified as a controlled substance by the DEA.

What is the generic name for ORAL PAIN RELIEF?

The generic name for ORAL PAIN RELIEF is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for ORAL PAIN RELIEF 20 g/100g?

The NDC (National Drug Code) for ORAL PAIN RELIEF 20 g/100g is 43473-100, listed by Nantong Health & Beyond Hygienic Products Inc..

Product NDC

43473-100

Package NDC

43473-100-04

Other Benzocaine Brands

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

Data from openFDA · Public domain (CC0 1.0)