NeutraCaine

Manufacturer: Invado Pharmaceuticals, LLC
Effective date: 2014-04-07
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:36:44

Label at a glance#

ProductNeutraCaine

Active ingredientBENZOCAINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

For temporary relief of inflammation and pain in the oral cavity: * mouth * tongue *cheeks

Dosage and administration

Dissolve one packet of NeutraCaine® in a clean glass of 30 mL (1 ounce) of tap water. Distilled, bottled or purified water can also be used. Use immediately after the solution appears clear or nearly clear in the glass, or in about 15 seconds. Stir if necessary (1) Swish 1/2 the solution in the mouth for 1 min and spit out. (2) Repeat with the remaining 1/2 of the solution and spit out Adults and children 12 year...

Contacts and useful links#

Websitewww.neutracaine.com

www.NeutraCaine.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NeutraCaine (Calcium Phosphate Rinse with Benzocaine)

Drug Facts

Active Ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine hydrochloride 90 mg (3mg/ml)

Purpose

OTC - PURPOSE SECTION

Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of inflammation and pain in the oral cavity:

* mouth * tongue *cheeks

Warnings

WARNINGS SECTION

This product contains benzocaine. The use of benzocaine applied to the mouth or gums has been associated with methemoglobinemia (a condition where the amount of oxygen in the blood stream is reduced).

Stop using

OTC - STOP USE SECTION

immediately if you experience any of the following symptoms and seek medical attention:

Pale, gray or blue colored skin, lips, or nail beds
Headache or lightheadedness

Ask a doctor if:

OTC - ASK DOCTOR SECTION

Sore mouth symptoms do not improve in 7 days
Irritation, pain or swelling persists or worsens

When using this product:

OTC - WHEN USING SECTION

NeutraCaine® must be mixed with water before use
NeutraCaine® rinse should not be swallowed
NeutraCaine® rinse should be spit out after use

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, immediately call Poison Control Center or doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Dissolve one packet of NeutraCaine® in a clean glass of 30 mL (1 ounce) of tap water. Distilled, bottled or purified water can also be used. Use immediately after the solution appears clear or nearly clear in the glass, or in about 15 seconds. Stir if necessary
(1) Swish 1/2 the solution in the mouth for 1 min and spit out.
(2) Repeat with the remaining 1/2 of the solution and spit out

Adults and children 12 years and over	Use NeutraCaine up to 4 times per day, as needed; Do not exceed recommended dosage
Children under 12 years of age	Use NeutraCaine up to 4 times per day, as needed; Should be supervised by an adult; Do not exceed recommended dosage
Children under 2 years	Ask a doctor or dentist

DO NOT USE

OTC - DO NOT USE SECTION

FOR MORE THAN 7 DAYS UNLESS DIRECTED BY PHYSICIAN

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature ■ Avoid excessive heat or moisture
Do not use if foil packet is opened or shows signs of leakage or damage

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium Chloride, Sodium Phosphate, Sodium Chloride, Sodium Bicarbonate, Cherry Flavoring

Manufactured for Invado Pharmaceuticals, LLC
Pomono, NY 10970
Made in Canada
www.NeutraCaine.com
Patents Pending
UPC Code 793573756282

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49939-201-01
NeutraCaine
(Calcium Phosphate Rinse with Benzocaine)
For relief of oral mucocitis pain
Mix with water before use
30 Packets Dissolving Powder
491 mg per packet | Net wt.14.73g

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0793573756282	GTIN-13: 0793573756282 EAN-13: 0793573756282 GTIN-12: 793573756282 UPC-A: 793573756282 GTIN storage (14 digits): 00793573756282	neutracaine-1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49939-201-01	2025-11-18	C162847	48780-1	9855e2a2-38ee-60a7-e053-dbdaa90a05bd	NeutraCaine
49939-201-01	2019-11-27	C162847	48780-1	9855e2a2-38ee-60a7-e053-dbdaa90a05bd	NeutraCaine

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49939-201	NEUTRACAINE (BENZOCAINE HYDROCHLORIDE) POWDER, FOR SOLUTION [INVADO PHARMACEUTICALS, LLC]	3	Legacy NDC	20140407_3469ec91-abf1-41c7-b67c-46335e9cbd70.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	OG625Z9LEO	3
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	3
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	3
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	3

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NeutraCaine
Benzocaine hydrochloride
BENZOCAINE
CALCIUM CHLORIDE
SODIUM PHOSPHATE
SODIUM CHLORIDE
SODIUM BICARBONATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49939-201	49939-201-01

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 HYDROCHLORIDE	OG625Z9LEO	ACTIB
CALCIUM CHLORIDE	M4I0D6VV5M	IACT
SODIUM PHOSPHATE	SE337SVY37	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM BICARBONATE	8MDF5V39QO	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 4 · 208 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		3059 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / EPIDURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET / BUCCAL		42 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / IONTOPHORESIS	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBARACHNOID	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAMUSCULAR		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
CALCIUM CHLORIDE	CALCIUM CHLORIDE	M4I0D6VV5M	SOLUTION / INTRAPERITONEAL	0.03 %w/v		Exact identifier — unii candidate 16 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	INJECTION / INTRAMUSCULAR	10.6 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		3219 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GUM, CHEWING / ORAL		360 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / ENDOTRACHEAL		68 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	LOZENGE / ORAL		100 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ENDOTRACHEAL	46.76 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
CALCIUM CHLORIDE	CALCIUM CHLORIDE	M4I0D6VV5M	SOLUTION / INTRAOCULAR		24 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
CALCIUM CHLORIDE	CALCIUM CHLORIDE	M4I0D6VV5M	SOLUTION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRATHECAL	0.05 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / OPHTHALMIC	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		24 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, COATED / ORAL	10.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAVITARY	0.82 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	INJECTION, SOLUTION / INTRAVENOUS	0.14 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAVENOUS	812 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / TOPICAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	OINTMENT / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, DENTIFRICE / DENTAL	0.03 mg/mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 34 equally ranked IID candidates
CALCIUM CHLORIDE	CALCIUM CHLORIDE	M4I0D6VV5M	INJECTION / INTRAMUSCULAR	4 %w/v		Exact identifier — unii candidate 16 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / PARENTERAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVASCULAR	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
CALCIUM CHLORIDE	CALCIUM CHLORIDE	M4I0D6VV5M	SOLUTION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 16 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INFILTRATION		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 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
43f76864-413a-d235-e063-6394a90a8e1e			3469ec91-abf1-41c7-b67c-46335e9cbd70	2025-11-19	Warnings	Exact identifier spl set id: 3469ec91-abf1-41c7-b67c-46335e9cbd70

Reported adverse events (FAERS/openFDA)#

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