theraworx pain relief roll- on- lidocaine

Generic: lidocaine hydrochloride

Labeler: avadim holdings, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name theraworx pain relief roll- on- lidocaine
Generic Name lidocaine hydrochloride
Labeler avadim holdings, inc.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 40 mg/mL

Manufacturer
AVADIM HOLDINGS, INC.

Identifiers & Regulatory

Product NDC 61594-028
Product ID 61594-028_08645940-ca97-3f2b-e063-6394a90a386f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2024-01-15

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 61594028
Hyphenated Format 61594-028

Supplemental Identifiers

RxCUI
1987647
UPC
0850005308911
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 theraworx pain relief roll- on- lidocaine (source: ndc)
Generic Name lidocaine hydrochloride (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (61594-028-00) / 74 mL in 1 BOTTLE
source: ndc

Packages (1)

61594-028-00 1 BOTTLE in 1 CARTON (61594-028-00) / 74 mL in 1 BOTTLE

Ingredients (1)

lidocaine hydrochloride (40 mg/mL)

Linked Drug Pages (1)

Theraworx Pain Relief Roll- On- Lidocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "08645940-ca97-3f2b-e063-6394a90a386f", "openfda": {"upc": ["0850005308911"], "unii": ["V13007Z41A"], "rxcui": ["1987647"], "spl_set_id": ["b4ce3876-f9e3-43ca-810b-75fbe6f887b6"], "manufacturer_name": ["AVADIM HOLDINGS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (61594-028-00)  / 74 mL in 1 BOTTLE", "package_ndc": "61594-028-00", "marketing_start_date": "20240115"}], "brand_name": "Theraworx Pain Relief Roll- On- Lidocaine", "product_id": "61594-028_08645940-ca97-3f2b-e063-6394a90a386f", "dosage_form": "LIQUID", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "61594-028", "generic_name": "LIDOCAINE HYDROCHLORIDE", "labeler_name": "AVADIM HOLDINGS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraworx Pain Relief Roll- On- Lidocaine", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240115", "listing_expiration_date": "20261231"}