biofreeze ultraflex

Generic: lidocaine

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name biofreeze ultraflex
Generic Name lidocaine
Labeler rb health (us) llc
Dosage Form PATCH
Routes
TOPICAL
Active Ingredients

lidocaine .04 g/g

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 59316-899
Product ID 59316-899_30dfaa6b-e80e-20a0-e063-6294a90a200b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2025-01-15

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 59316899
Hyphenated Format 59316-899

Supplemental Identifiers

RxCUI
1737778
UPC
0731124444967
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 biofreeze ultraflex (source: ndc)
Generic Name lidocaine (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .04 g/g
source: ndc
Packaging
  • 4 PATCH in 1 CARTON (59316-899-04) / 2 g in 1 PATCH
  • 1 PATCH in 1 POUCH (59316-899-07) / 2 g in 1 PATCH
source: ndc

Packages (2)

59316-899-04 4 PATCH in 1 CARTON (59316-899-04) / 2 g in 1 PATCH 59316-899-07 1 PATCH in 1 POUCH (59316-899-07) / 2 g in 1 PATCH

Ingredients (1)

lidocaine (.04 g/g)

Linked Drug Pages (1)

Biofreeze Ultraflex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "30dfaa6b-e80e-20a0-e063-6294a90a200b", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0731124444967"], "unii": ["98PI200987"], "rxcui": ["1737778"], "spl_set_id": ["2655974b-a67d-9f07-e063-6294a90a54e8"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 PATCH in 1 CARTON (59316-899-04)  / 2 g in 1 PATCH", "package_ndc": "59316-899-04", "marketing_start_date": "20250115"}, {"sample": false, "description": "1 PATCH in 1 POUCH (59316-899-07)  / 2 g in 1 PATCH", "package_ndc": "59316-899-07", "marketing_start_date": "20250115"}], "brand_name": "Biofreeze Ultraflex", "product_id": "59316-899_30dfaa6b-e80e-20a0-e063-6294a90a200b", "dosage_form": "PATCH", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "59316-899", "generic_name": "Lidocaine", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Biofreeze Ultraflex", "active_ingredients": [{"name": "LIDOCAINE", "strength": ".04 g/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}