FDA.reportPublic FDA data

Orajel Toothache Rinse

Product NDC
10237-764
11-digit product format
102370764
Labeler code
10237
Product ID
10237-764_27e7c3b6-5f9a-a7f3-e063-6394a90a02a7
Type
HUMAN OTC DRUG
Nonproprietary name
Benzyl Alcohol, Zinc Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Church & Dwight Co., Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-12-01
Substance
BENZYL ALCOHOL; ZINC CHLORIDE
Active strength
2.7; 1.5 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Orajel Toothache Rinse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZYL ALCOHOL2.7 mg/mL
ZINC CHLORIDE1.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLKG8494WBH, 86Q357L16B
Rxcui1865199

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1865199benzyl alcohol 0.27 % / zinc chloride 0.15 % Mucous Membrane Topical SolutionPSN41709710-5392-3119-e054-00144ff88e888
1865199benzyl alcohol 2.7 MG/ML / zinc chloride 1.5 MG/ML Mucous Membrane Topical SolutionSCD41709710-5392-3119-e054-00144ff88e888
1865199benzyl alcohol 0.27 % / zinc chloride 0.15 % Mucous Membrane Topical SolutionSY41709710-5392-3119-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-764-0810237076408236.6 mL in 1 BOTTLE (10237-764-08) 236.6 ml2016-12-010000-00-00NoNoCurrent
10237-764-1610237076416473.2 mL in 1 BOTTLE (10237-764-16) 473.2 ml2016-12-010000-00-00NoNoCurrent