cetacaine anesthetic

Generic: benzocaine, butamben, and tetracaine hydrochloride

Labeler: cetylite industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name cetacaine anesthetic
Generic Name benzocaine, butamben, and tetracaine hydrochloride
Labeler cetylite industries, inc.
Dosage Form AEROSOL, SPRAY
Routes
TOPICAL
Active Ingredients

benzocaine .028 g/.2g, butamben .004 g/.2g, tetracaine hydrochloride .004 g/.2g

Manufacturer
Cetylite Industries, Inc.

Identifiers & Regulatory

Product NDC 10223-0201
Product ID 10223-0201_ac4f8056-7c1b-461f-86c3-f5e44cbe4249
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 1958-01-01

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 102230201
Hyphenated Format 10223-0201

Supplemental Identifiers

RxCUI
999683 1722107
UNII
U3RSY48JW5 EFW857872Q 5NF5D4OPCI
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 cetacaine anesthetic (source: ndc)
Generic Name benzocaine, butamben, and tetracaine hydrochloride (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .028 g/.2g
  • .004 g/.2g
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 BOX (10223-0201-3) / 20 g in 1 BOTTLE, GLASS
  • 1 BOTTLE, GLASS in 1 BOX (10223-0201-4) / 5 g in 1 BOTTLE, GLASS
source: ndc

Packages (2)

10223-0201-3 1 BOTTLE, GLASS in 1 BOX (10223-0201-3) / 20 g in 1 BOTTLE, GLASS 10223-0201-4 1 BOTTLE, GLASS in 1 BOX (10223-0201-4) / 5 g in 1 BOTTLE, GLASS

Ingredients (3)

benzocaine (.028 g/.2g) butamben (.004 g/.2g) tetracaine hydrochloride (.004 g/.2g)

Linked Drug Pages (1)

Cetacaine Anesthetic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ac4f8056-7c1b-461f-86c3-f5e44cbe4249", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5", "EFW857872Q", "5NF5D4OPCI"], "rxcui": ["999683", "1722107"], "spl_set_id": ["af1773c5-5d5b-4278-b551-30ad2df6d5b5"], "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": ["Cetylite Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 BOX (10223-0201-3)  / 20 g in 1 BOTTLE, GLASS", "package_ndc": "10223-0201-3", "marketing_start_date": "20160101"}, {"sample": false, "description": "1 BOTTLE, GLASS in 1 BOX (10223-0201-4)  / 5 g in 1 BOTTLE, GLASS", "package_ndc": "10223-0201-4", "marketing_start_date": "20171101"}], "brand_name": "Cetacaine Anesthetic", "product_id": "10223-0201_ac4f8056-7c1b-461f-86c3-f5e44cbe4249", "dosage_form": "AEROSOL, SPRAY", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Ester Local Anesthetic [EPC]", "Esters [CS]", "Increased Histamine Release [PE]", "Local Anesthesia [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "10223-0201", "generic_name": "Benzocaine, Butamben, and Tetracaine Hydrochloride", "labeler_name": "Cetylite Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetacaine Anesthetic", "active_ingredients": [{"name": "BENZOCAINE", "strength": ".028 g/.2g"}, {"name": "BUTAMBEN", "strength": ".004 g/.2g"}, {"name": "TETRACAINE HYDROCHLORIDE", "strength": ".004 g/.2g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "19580101", "listing_expiration_date": "20261231"}