dentek instant pain relief maximum strength

Generic: benzocaine

Labeler: dentek oral care, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dentek instant pain relief maximum strength
Generic Name benzocaine
Labeler dentek oral care, inc.
Dosage Form LIQUID
Routes
DENTAL TOPICAL
Active Ingredients

benzocaine 200 mg/mL

Manufacturer
DenTek Oral Care, Inc.

Identifiers & Regulatory

Product NDC 60630-078
Product ID 60630-078_b1654017-9b63-4ab6-b461-09617e6787ad
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2015-07-31

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 60630078
Hyphenated Format 60630-078

Supplemental Identifiers

RxCUI
308657
UNII
U3RSY48JW5
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 dentek instant pain relief maximum strength (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (60630-078-01) / 3.5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

60630-078-01 1 VIAL, GLASS in 1 CARTON (60630-078-01) / 3.5 mL in 1 VIAL, GLASS

Ingredients (1)

benzocaine (200 mg/mL)

Linked Drug Pages (1)

DenTek Instant Pain Relief Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL", "TOPICAL"], "spl_id": "b1654017-9b63-4ab6-b461-09617e6787ad", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["308657"], "spl_set_id": ["ae92b76e-815a-4b4c-8128-bd045098caa5"], "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": ["DenTek Oral Care, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (60630-078-01)  / 3.5 mL in 1 VIAL, GLASS", "package_ndc": "60630-078-01", "marketing_start_date": "20150731"}], "brand_name": "DenTek Instant Pain Relief Maximum Strength", "product_id": "60630-078_b1654017-9b63-4ab6-b461-09617e6787ad", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "60630-078", "generic_name": "Benzocaine", "labeler_name": "DenTek Oral Care, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DenTek Instant Pain Relief Maximum Strength", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150731", "listing_expiration_date": "20261231"}