topicale

Generic: benzocaine

Labeler: medical products laboratories, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topicale
Generic Name benzocaine
Labeler medical products laboratories, inc.
Dosage Form GEL
Routes
ORAL
Active Ingredients

benzocaine 180 mg/g

Manufacturer
Medical Products Laboratories, Inc.

Identifiers & Regulatory

Product NDC 10733-171
Product ID 10733-171_28dd17ff-9097-d336-e063-6394a90a00fd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2019-03-05

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 10733171
Hyphenated Format 10733-171

Supplemental Identifiers

RxCUI
1042838 1049213
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 topicale (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/g
source: ndc
Packaging
  • 43 g in 1 BOTTLE, PUMP (10733-171-43)
source: ndc

Packages (1)

10733-171-43 43 g in 1 BOTTLE, PUMP (10733-171-43)

Ingredients (1)

benzocaine (180 mg/g)

Linked Drug Pages (1)

Topicale ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "28dd17ff-9097-d336-e063-6394a90a00fd", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["1042838", "1049213"], "spl_set_id": ["8281700c-10f9-841c-e053-2991aa0a918f"], "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": ["Medical Products Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "43 g in 1 BOTTLE, PUMP (10733-171-43)", "package_ndc": "10733-171-43", "marketing_start_date": "20190305"}], "brand_name": "Topicale", "product_id": "10733-171_28dd17ff-9097-d336-e063-6394a90a00fd", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "10733-171", "generic_name": "Benzocaine", "labeler_name": "Medical Products Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topicale", "active_ingredients": [{"name": "BENZOCAINE", "strength": "180 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190305", "listing_expiration_date": "20261231"}