FDA.reportPublic FDA data

4X Medicated Toothache and Gum Gel

Product NDC
49035-569
11-digit product format
490350569
Labeler code
49035
Product ID
49035-569_437fd35c-d085-cbb8-e063-6394a90a1c11
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
ORAL
Labeler
Walmart
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-18
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL; ZINC CHLORIDE
Active strength
.13; 20; .5; .15 g/100g; 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
4X Medicated Toothache and Gum Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g
BENZOCAINE20 g/100g
MENTHOL.5 g/100g
ZINC CHLORIDE.15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, U3RSY48JW5, L7T10EIP3A, 86Q357L16B
Rxcui2369638

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-569-994X Medicated Toothache and Gum Gel1 g in 1 TUBEGEL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-5694X MEDICATED TOOTHACHE AND GUM GEL (BENZOCAINE) GEL [WALMART]4Current NDC, Legacy NDC, 1 package rows20250120_a471a858-edbf-c31e-e053-2995a90a7156.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369638benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral GelPSNa471a858-edbf-c31e-e053-2995a90a71566
2369638benzalkonium chloride 0.0013 MG/MG / benzocaine 0.2 MG/MG / menthol 0.005 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCDa471a858-edbf-c31e-e053-2995a90a71566
2369638benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral GelSYa471a858-edbf-c31e-e053-2995a90a71566

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-569-99490350569991 g in 1 TUBE (49035-569-99) 1 g2020-05-180000-00-00NoNoCurrent