topical cream

Generic: lidocaine

Labeler: bloomwell gardens llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topical cream
Generic Name lidocaine
Labeler bloomwell gardens llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

lidocaine 4 g/100g

Manufacturer
BLOOMWELL GARDENS LLC

Identifiers & Regulatory

Product NDC 85284-002
Product ID 85284-002_37bd328e-83bb-781d-e063-6294a90ad8a4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2025-06-16

Pharmacologic Class

Established (EPC)
amide local anesthetic [epc] antiarrhythmic [epc]
Chemical Structure
amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85284002
Hyphenated Format 85284-002

Supplemental Identifiers

RxCUI
1421893
UNII
98PI200987
NUI
N0000175682 M0000897 N0000175426 N0000175976

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 topical cream (source: ndc)
Generic Name lidocaine (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 4 g/100g
source: ndc
Packaging
  • 50 g in 1 BOTTLE, PLASTIC (85284-002-01)
source: ndc

Packages (1)

85284-002-01 50 g in 1 BOTTLE, PLASTIC (85284-002-01)

Ingredients (1)

lidocaine (4 g/100g)

Linked Drug Pages (1)

Topical Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "37bd328e-83bb-781d-e063-6294a90ad8a4", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "unii": ["98PI200987"], "rxcui": ["1421893"], "spl_set_id": ["37bd328e-83ba-781d-e063-6294a90ad8a4"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["BLOOMWELL GARDENS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 g in 1 BOTTLE, PLASTIC (85284-002-01)", "package_ndc": "85284-002-01", "marketing_start_date": "20250616"}], "brand_name": "Topical Cream", "product_id": "85284-002_37bd328e-83bb-781d-e063-6294a90ad8a4", "dosage_form": "CREAM", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "85284-002", "generic_name": "Lidocaine", "labeler_name": "BLOOMWELL GARDENS LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topical Cream", "active_ingredients": [{"name": "LIDOCAINE", "strength": "4 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250616", "listing_expiration_date": "20261231"}