FDA.reportPublic FDA data

4x Medicated Toothache and Gum Cream

Product NDC
37808-116
11-digit product format
378080116
Labeler code
37808
Product ID
37808-116_47e513f5-736f-c398-e063-6394a90a025d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
CREAM
Route
ORAL
Labeler
HEB
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-02
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL, UNSPECIFIED FORM; ZINC CHLORIDE
Active strength
.13; 20; .25; .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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
4x Medicated Toothache and Gum Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g
BENZOCAINE20 g/100g
MENTHOL, UNSPECIFIED FORM.25 g/100g
ZINC CHLORIDE.15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, U3RSY48JW5, L7T10EIP3A, 86Q357L16B
Rxcui2370903

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
37808-116-694x Medicated Toothache and Gum Cream9.4 g in 1 TUBECREAM9.46
37808-116-694x Medicated Toothache and Gum Cream1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-1164X MEDICATED TOOTHACHE AND GUM CREAM (BENZOCAINE) CREAM [HEB]4Current NDC, Legacy NDC, 2 package rows20250413_a71c5259-cbcf-7566-e053-2995a90a2cb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamPSNa71c5259-cbcf-7566-e053-2995a90a2cb66
2370903benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral CreamSCDa71c5259-cbcf-7566-e053-2995a90a2cb66
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamSYa71c5259-cbcf-7566-e053-2995a90a2cb66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-116-69378080116691 TUBE in 1 CARTON (37808-116-69) / 9.4 g in 1 TUBE1 tube2020-06-020000-00-00NoNoCurrent