FDA.reportPublic FDA data

3x Medicated Mouth Sore Gel

Product NDC
0363-1605
11-digit product format
003631605
Labeler code
0363
Product ID
0363-1605_437fcace-4b78-b891-e063-6294a90ac3cb
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
ORAL
Labeler
Walgreens
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-20
Substance
BENZOCAINE; MENTHOL, UNSPECIFIED FORM; ZINC CHLORIDE
Active strength
20; .1; .15 g/100g; g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
3x Medicated Mouth Sore Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g
MENTHOL, UNSPECIFIED FORM.1 g/100g
ZINC CHLORIDE.15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, L7T10EIP3A, 86Q357L16B
Rxcui2266762

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1605-193x Medicated Mouth Sore Gel11.9 g in 1 TUBEGEL11.98
0363-1605-193x Medicated Mouth Sore Gel1 in 1 CARTONGEL18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-16053X MEDICATED MOUTH SORE GEL (BENZOCAINE) GEL [WALGREENS]6Current NDC, Legacy NDC, 2 package rows20250121_ad509f2a-05de-6c77-e053-2995a90ae526.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2266762benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral GelPSNad509f2a-05de-6c77-e053-2995a90ae5268
2266762benzocaine 0.2 MG/MG / menthol 0.001 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCDad509f2a-05de-6c77-e053-2995a90ae5268
2266762benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral GelSYad509f2a-05de-6c77-e053-2995a90ae5268

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1605-19003631605191 TUBE in 1 CARTON (0363-1605-19) / 11.9 g in 1 TUBE1 tube2021-10-200000-00-00NoNoCurrent
0363-1605-51003631605511 TUBE in 1 CARTON (0363-1605-51) > 11.9 g in 1 TUBE1 tube2021-07-010000-00-00NoNoCurrent