4x medicated toothache and gum cream

Generic: benzocaine

Labeler: heb
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name 4x medicated toothache and gum cream
Generic Name benzocaine
Labeler heb
Dosage Form CREAM
Routes
ORAL
Active Ingredients

benzalkonium chloride .13 g/100g, benzocaine 20 g/100g, menthol, unspecified form .25 g/100g, zinc chloride .15 g/100g

Manufacturer
HEB

Identifiers & Regulatory

Product NDC 37808-116
Product ID 37808-116_47e513f5-736f-c398-e063-6394a90a025d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2027-12-31
Marketing Start 2020-06-02

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808116
Hyphenated Format 37808-116

Supplemental Identifiers

RxCUI
2370903
UPC
0041220838189
UNII
F5UM2KM3W7 U3RSY48JW5 L7T10EIP3A 86Q357L16B
NUI
N0000185508 N0000175629 N0000184306 M0000728

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name 4x medicated toothache and gum cream (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .13 g/100g
  • 20 g/100g
  • .25 g/100g
  • .15 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (37808-116-69) / 9.4 g in 1 TUBE
source: ndc

Packages (1)

37808-116-69 1 TUBE in 1 CARTON (37808-116-69) / 9.4 g in 1 TUBE

Ingredients (4)

benzalkonium chloride (.13 g/100g) benzocaine (20 g/100g) menthol, unspecified form (.25 g/100g) zinc chloride (.15 g/100g)

Linked Drug Pages (1)

4x Medicated Toothache and Gum Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e513f5-736f-c398-e063-6394a90a025d", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0041220838189"], "unii": ["F5UM2KM3W7", "U3RSY48JW5", "L7T10EIP3A", "86Q357L16B"], "rxcui": ["2370903"], "spl_set_id": ["a71c5259-cbcf-7566-e053-2995a90a2cb6"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["HEB"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (37808-116-69)  / 9.4 g in 1 TUBE", "package_ndc": "37808-116-69", "marketing_start_date": "20200602"}], "brand_name": "4x Medicated Toothache and Gum Cream", "product_id": "37808-116_47e513f5-736f-c398-e063-6394a90a025d", "dosage_form": "CREAM", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "37808-116", "generic_name": "Benzocaine", "labeler_name": "HEB", "product_type": "HUMAN OTC DRUG", "brand_name_base": "4x Medicated Toothache and Gum Cream", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": ".13 g/100g"}, {"name": "BENZOCAINE", "strength": "20 g/100g"}, {"name": "MENTHOL, UNSPECIFIED FORM", "strength": ".25 g/100g"}, {"name": "ZINC CHLORIDE", "strength": ".15 g/100g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200602", "listing_expiration_date": "20271231"}