burn cream

Generic: benzalkonium chloride, lidocaine hci

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name burn cream
Generic Name benzalkonium chloride, lidocaine hci
Labeler trifecta pharmaceuticals usa llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

benzalkonium chloride .0013 g/g, lidocaine hydrochloride .005 g/g

Manufacturer
Trifecta Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 69396-136
Product ID 69396-136_4af5a82b-f212-7f5c-e063-6394a90a6852
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2027-12-31
Marketing Start 2023-10-23

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396136
Hyphenated Format 69396-136

Supplemental Identifiers

RxCUI
1012100
UPC
0850058161266 0766588195414
UNII
F5UM2KM3W7 V13007Z41A

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 burn cream (source: ndc)
Generic Name benzalkonium chloride, lidocaine hci (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .0013 g/g
  • .005 g/g
source: ndc
Packaging
  • 10 PACKET in 1 CARTON (69396-136-10) / .9 g in 1 PACKET
  • 25 PACKET in 1 CARTON (69396-136-25) / .9 g in 1 PACKET
source: ndc

Packages (2)

69396-136-10 10 PACKET in 1 CARTON (69396-136-10) / .9 g in 1 PACKET 69396-136-25 25 PACKET in 1 CARTON (69396-136-25) / .9 g in 1 PACKET

Ingredients (2)

benzalkonium chloride (.0013 g/g) lidocaine hydrochloride (.005 g/g)

Linked Drug Pages (1)

Burn Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4af5a82b-f212-7f5c-e063-6394a90a6852", "openfda": {"upc": ["0850058161266", "0766588195414"], "unii": ["F5UM2KM3W7", "V13007Z41A"], "rxcui": ["1012100"], "spl_set_id": ["087ac43c-1076-d1e2-e063-6294a90a5859"], "manufacturer_name": ["Trifecta Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 PACKET in 1 CARTON (69396-136-10)  / .9 g in 1 PACKET", "package_ndc": "69396-136-10", "marketing_start_date": "20231023"}, {"sample": false, "description": "25 PACKET in 1 CARTON (69396-136-25)  / .9 g in 1 PACKET", "package_ndc": "69396-136-25", "marketing_start_date": "20231023"}], "brand_name": "Burn Cream", "product_id": "69396-136_4af5a82b-f212-7f5c-e063-6394a90a6852", "dosage_form": "CREAM", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "69396-136", "generic_name": "Benzalkonium Chloride, Lidocaine HCI", "labeler_name": "Trifecta Pharmaceuticals USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Burn Cream", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": ".0013 g/g"}, {"name": "LIDOCAINE HYDROCHLORIDE", "strength": ".005 g/g"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231023", "listing_expiration_date": "20271231"}