1168

Generic: 1168 burn spray

Labeler: dynarex corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name 1168
Generic Name 1168 burn spray
Labeler dynarex corporation
Dosage Form SPRAY
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride .02 mg/mL

Manufacturer
Dynarex Corporation

Identifiers & Regulatory

Product NDC 67777-013
Product ID 67777-013_1183a4f5-f876-dfb0-e063-6394a90af35f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2024-02-29

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 67777013
Hyphenated Format 67777-013

Supplemental Identifiers

UPC
0840117332751
UNII
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 1168 (source: ndc)
Generic Name 1168 burn spray (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .02 mg/mL
source: ndc
Packaging
  • 24 BOTTLE, SPRAY in 1 CASE (67777-013-05) / 59.1 mL in 1 BOTTLE, SPRAY (67777-013-06)
source: ndc

Packages (1)

67777-013-05 24 BOTTLE, SPRAY in 1 CASE (67777-013-05) / 59.1 mL in 1 BOTTLE, SPRAY (67777-013-06)

Ingredients (1)

lidocaine hydrochloride (.02 mg/mL)

Linked Drug Pages (1)

1168 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1183a4f5-f876-dfb0-e063-6394a90af35f", "openfda": {"upc": ["0840117332751"], "unii": ["V13007Z41A"], "spl_set_id": ["1183a4f5-f875-dfb0-e063-6394a90af35f"], "manufacturer_name": ["Dynarex Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BOTTLE, SPRAY in 1 CASE (67777-013-05)  / 59.1 mL in 1 BOTTLE, SPRAY (67777-013-06)", "package_ndc": "67777-013-05", "marketing_start_date": "20240229"}], "brand_name": "1168", "product_id": "67777-013_1183a4f5-f876-dfb0-e063-6394a90af35f", "dosage_form": "SPRAY", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "67777-013", "generic_name": "1168 Burn Spray", "labeler_name": "Dynarex Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "1168", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": ".02 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240229", "listing_expiration_date": "20261231"}