Rite Aid

Manufacturer: Rite Aid | Lornamead Products | HK KOLMAR CANADA, INC
Effective date: 2025-11-13
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-06-01 01:16:02

Label at a glance#

ProductRite Aid Maximum Strength

Active ingredientBENZOCAINE

Label structure9 sections

Storage and handling

Other information do not use if package has been opened store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzocaine 20% (w/w)

OTC - PURPOSE SECTION

Purpose

Oral anesthetic

INDICATIONS & USAGE SECTION

Use

temporarily relieves pain associated with the following mouth irritations

toothache
sore gums
canker sores
braces
minor dental procedures

WARNINGS SECTION

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in yoru care develops:

pale, gray, or blue colored skin (cyanosis)
headache
rapid heart rate
shortness of breath
dizziness or lighteadedness
fatigue or lack of energy

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

OTC - DO NOT USE SECTION

Do not use

more than directed
for more than 7 days unless directed by a dentist or doctor
for teething
in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a doctor if

swelling, rash or fever develops
irritation, pain or redness persists or worsens
symptoms do not improve in 7 days
allergic reaction occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and older:

apply to affected area using applicator tip
use up to 4 times daily or as directed by a dentist or doctor
children under 12 years of age should be supervised in the use of this product

children under 2 years of age: do not use

STORAGE AND HANDLING SECTION

Other information

do not use if package has been opened
store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, Methylparaben, Natural and Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

MADE IN CANADA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Card R5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308657	benzocaine 20 % Mucous Membrane Topical Solution	PSN	15
308657	benzocaine 200 MG/ML Mucous Membrane Topical Solution	SCD	15
308657	benzocaine 20 % Mucous Membrane Topical Solution	SY	15

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11822-0345-1	Rite AidMaximum Strength	14.7 g in 1 BOTTLE	LIQUID	14.7		15
11822-0345-7	Rite AidMaximum Strength	1 in 1 CARTON	LIQUID	1		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Rite Aid Maximum Strength
Benzocaine
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SACCHARIN SODIUM
METHYLPARABEN
BENZYL ALCOHOL
FD&C RED NO. 40
D&C YELLOW NO. 10
FD&C BLUE NO. 1
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11822-0345	11822-0345-1, 11822-0345-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
WATER	059QF0KO0R	IACT
BENZOCAINE	U3RSY48JW5	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 213 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CONCENTRATE / ORAL		3000 mg	Exact identifier — unii+route 51 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route 63 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 51 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii+route 63 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / ORAL		8 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii+route 51 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii+route 66 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii+route 51 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route 66 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CONCENTRATE / ORAL	0.03 mg/1ml		Exact identifier — unii+route 63 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION, CONCENTRATE / ORAL		2813 mg	Exact identifier — unii+route 51 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route 63 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii+route 51 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route 63 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	ELIXIR / ORAL	0.3 mg/15ml		Exact identifier — unii+route 63 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii+route 51 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE / ORAL	20 mg		Exact identifier — unii+route 63 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii+route 51 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii+route 51 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CONCENTRATE / ORAL	0.03 mg/1ml		Exact identifier — unii+route 63 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 66 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii+route 21 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 66 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii+route 63 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / ORAL		2 mg	Exact identifier — unii+route 63 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE / ORAL	20 mg		Exact identifier — unii+route 63 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii+route 66 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE / ORAL		450 mg	Exact identifier — unii+route 21 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii+route 66 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii+route 63 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SYRUP / ORAL		4 mg	Exact identifier — unii+route 63 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 63 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route 66 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER, FOR SUSPENSION / ORAL		76 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / ORAL		70200 mg	Exact identifier — unii+route 51 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, EXTENDED RELEASE / ORAL		14 mg	Exact identifier — unii+route 63 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route 66 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, DELAYED RELEASE / ORAL	1.9 mg		Exact identifier — unii+route 63 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii+route 63 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii+route 66 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route 63 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii+route 51 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rite Aid Maximum Strength	BENZOCAINE	Rite Aid	340ccdab-0a02-454c-8d44-ced5667276ab	2025-11-13	Warnings	Exact identifier ndc (package): 11822-0345-7 ndc (package): 11822-0345-1 ndc (product): 11822-0345 ndc11 (package): 11822034507 ndc11 (package): 11822034501 spl id: 437fc201-e0df-b2d6-e063-6394a90a9d24 spl set id: 340ccdab-0a02-454c-8d44-ced5667276ab

Reported adverse events (FAERS/openFDA)#

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