biofreeze ultraflex plus

Generic: lidocaine, menthol

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

Drug Facts

Product Profile

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

lidocaine .04 g/g, menthol .01 g/g

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 59316-898
Product ID 59316-898_401e1256-05df-d4a9-e063-6294a90adce4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2026-01-31

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 59316898
Hyphenated Format 59316-898

Supplemental Identifiers

RxCUI
1249758
UPC
0731124445261
UNII
98PI200987 L7T10EIP3A
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 plus (source: ndc)
Generic Name lidocaine, menthol (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .04 g/g
  • .01 g/g
source: ndc
Packaging
  • 4 PATCH in 1 CARTON (59316-898-04) / 2 g in 1 PATCH
  • 1 PATCH in 1 POUCH (59316-898-07) / 2 g in 1 PATCH
source: ndc

Packages (2)

Ingredients (2)

lidocaine (.04 g/g) menthol (.01 g/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "401e1256-05df-d4a9-e063-6294a90adce4", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0731124445261"], "unii": ["98PI200987", "L7T10EIP3A"], "rxcui": ["1249758"], "spl_set_id": ["401e1843-e9a6-fda9-e063-6294a90a3073"], "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 (59316-898-04)  / 2 g in 1 PATCH", "package_ndc": "59316-898-04", "marketing_start_date": "20260131"}, {"sample": false, "description": "1 PATCH in 1 POUCH (59316-898-07)  / 2 g in 1 PATCH", "package_ndc": "59316-898-07", "marketing_start_date": "20260131"}], "brand_name": "Biofreeze Ultraflex Plus", "product_id": "59316-898_401e1256-05df-d4a9-e063-6294a90adce4", "dosage_form": "PATCH", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "59316-898", "generic_name": "Lidocaine, Menthol", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Biofreeze Ultraflex Plus", "active_ingredients": [{"name": "LIDOCAINE", "strength": ".04 g/g"}, {"name": "MENTHOL", "strength": ".01 g/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260131", "listing_expiration_date": "20261231"}