Budpak Oral Maximum Strength

Manufacturer: Budpak Inc. | Anicare Pharmaceuticals Pvt. Ltd
Effective date: 2013-06-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:40

Label at a glance#

ProductBudpak Oral Maximum Strength

Active ingredientBENZOCAINE

Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzocaine 20%

OTC - PURPOSE SECTION

Purpose

Anesthetic

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of pain associated with:

toothache
canker sores
cold sores
fever blisters
minor dental procedures

WARNINGS SECTION

Warnings

do not use for more than 7 days unless directed by a dentist or a doctor
if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

OTC - WHEN USING SECTION

When using this product

avoid contact with the eyes
do not exceed recommended dosage

OTC - STOP USE SECTION

Stop using this product and ask a doctor

sore mouth symptoms do not improve in 7 days
swelling, rash or fever develops
irritation, pain or redness persists or worsens

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 2 years of age and older:

break seal on tube
apply to the affected area up to 4 times daily or as directed by a dentist or a doctor
children under 12 years of age should be supervised in the use of the product
children under 2 years of age, there is no recommended dosage except under the advice and supervision of a dentist or a doctor

SPL UNCLASSIFIED SECTION

Other Information

store at room temperature.
Lot. No and Exp. Date: see crimp of tube.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Ammonium Glycyrrhizate, Polyethylene glycol, Saccharin sodium, Sorbic acid, Flavor

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

ORAL MAXIMUM STRENGTH PAIN RELIEF GEL

Benzocaine 20%

Anesthetic

NET WT 0.5 OZ (14 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238910	benzocaine 20 % Oral Gel	PSN	1
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	1
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
27293-019-01	2020-01-31	C162847	48780-1	9d75b9d0-6a3c-f424-e053-dadaa90a57ce	f1908054-8527-421a-a023-0476a71c9691

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27293-019-01	Budpak Oral Maximum Strength	1 in 1 BOX	GEL	1		1
27293-019-14	Budpak Oral Maximum Strength	14 g in 1 TUBE	GEL	14		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27293-019	BUDPAK ORAL MAXIMUM STRENGTH (BENZOCAINE) GEL [BUDPAK INC.]	1	Legacy NDC, 2 package rows	20130610_f1908054-8527-421a-a023-0476a71c9691.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1
GLYCYRRHIZIN, AMMONIATED	INACTIVE INGREDIENT	3VRD35U26C	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Budpak Oral Maximum Strength
Benzocaine
GLYCYRRHIZIN, AMMONIATED
POLYETHYLENE GLYCOLS
SACCHARIN SODIUM
SORBIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
27293-019	27293-019-14, 27293-019-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB
GLYCYRRHIZIN, AMMONIATED	3VRD35U26C	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBIC ACID	X045WJ989B	IACT

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 1 · 53 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	GEL / TOPICAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, DELAYED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, FILM COATED / ORAL		5 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	EMULSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SOLUTION/ DROPS / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SOLUTION / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SOLUTION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET / ORAL		10 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET / SUBLINGUAL	0.16 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SUSPENSION / ORAL		40 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 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
91a75546-e237-4970-a30c-6af048b0b011			f1908054-8527-421a-a023-0476a71c9691	2013-06-08	Warnings	Exact identifier spl id: 91a75546-e237-4970-a30c-6af048b0b011 spl set id: f1908054-8527-421a-a023-0476a71c9691

Reported adverse events (FAERS/openFDA)#

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