Orajel Toothache Rinse

Manufacturer
Church & Dwight Co., Inc. | Church & Dwight Co., Inc
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:39:36

Label at a glance#

ProductOrajel Toothache Rinse
Active ingredientBENZYL ALCOHOL, ZINC CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzyl Alcohol 0.27%

Zinc Chloride 0.15%

OTC - PURPOSE SECTION

Oral pain reliever

Oral astringent

INDICATIONS & USAGE SECTION

Usefor temporary relief of pain due to toothaches, minor irritation of the mouth and gums, occasional minor irritation, pain, sore mouth and sore throat

WARNINGS SECTION

Warnings

Do not usethis product for more than 7 days unless directed by a dentist or healthcare provider

OTC - WHEN USING SECTION

When using this product• do not swallow • do not exceed recommended dosage

OTC - STOP USE SECTION

Stop use and see your physician promptly if• swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days • allergic reaction occurs • sore thoat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions

•remove imprinted safety seal from bottle cap

• to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.

Adults and children 2 years of age or over:

Swish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider

Children under 12 years of age:

Should be supervised in the use of this product

Children under 2 years of age:

Consult a dentist or healthcare provider

Other Information •cap tightly • keep away from heat or direct sunlight • do not use if safety seal is broken or missing

INACTIVE INGREDIENT SECTION

Inactive Ingredientsalcohol (4.1% by volume), blue 1, disodium pyrophosphate, menthol, methyl salicylate, poloxamer 338, polysorbate 20, sodium benzoate, sodium saccharin, sorbitol, tetrasodium pyrophosphate, water

OTC - QUESTIONS SECTION

Questions or commentscalls us at 800 952 5080 Monday through Friday 9 to 5 ET or visit our website at www orajel com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1

ORAL PAIN RELIEVER

BRAND FOR TOOTHACHE

NON-NUMBING RELIEF!

Orajel™

For TOOTHACHE

Analgesic & Astringent Rinse

Provides All-Over Oral Pain Relief

Soothes Irritated Gums

Cleans Affected Area

Kills Odor-Causing Bacteria

Soothing

Mint

Rinse

ORAL PAIN RELIEVER/

ASTRINGENT

16 FL OZ (473.2 mL)

DA2011186_OJLBF-43001-02_72013520DA2011186_OJLBF-43001-02_72013520

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1865199benzyl alcohol 0.27 % / zinc chloride 0.15 % Mucous Membrane Topical SolutionPSN8
1865199benzyl alcohol 2.7 MG/ML / zinc chloride 1.5 MG/ML Mucous Membrane Topical SolutionSCD8
1865199benzyl alcohol 0.27 % / zinc chloride 0.15 % Mucous Membrane Topical SolutionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZYL ALCOHOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-764-08Orajel Toothache Rinse236.6 mL in 1 BOTTLELIQUID236.68
10237-764-16Orajel Toothache Rinse473.2 mL in 1 BOTTLELIQUID473.28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-764ORAJEL TOOTHACHE RINSE (BENZYL ALCOHOL, ZINC CHLORIDE) LIQUID [CHURCH & DWIGHT CO., INC.]8Current NDC, Legacy NDC, 2 package rows20241128_41709710-5392-3119-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-76410237-764-16, 10237-764-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
ndc (package): 10237-764-08
ndc (package): 10237-764-16
ndc (product): 10237-764
ndc11 (package): 10237076416
ndc11 (package): 10237076408
spl id: 27e7c3b6-5f9a-a7f3-e063-6394a90a02a7
spl set id: 41709710-5392-3119-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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