Home NDC 84615-004 POMG PAIN RELIEF ROLLER
Product NDC 84615-004
11-digit product format 846150004
Labeler code 84615
Product ID 84615-004_47d03794-85ef-f653-e063-6294a90a9c17
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine Hydrochloride, Menthol
Dosage form GEL
Route TOPICAL
Labeler POMG LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-14
Substance MENTHOL; LIDOCAINE HYDROCHLORIDE
Active strength 50; 40 mg/mL; mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 84615-004 84615-004-02 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base POMG PAIN RELIEF ROLLER
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 50 mg/mL LIDOCAINE HYDROCHLORIDE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2690870 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84615-004-02 POMG PAIN RELIEF ROLLER 1 in 1 CARTON GEL 1 6 84615-004-02 POMG PAIN RELIEF ROLLER 59 mL in 1 BOTTLE, WITH APPLICATOR GEL 59 6 84615-004-03 POMG PAIN RELIEF ROLLER 90 mL in 1 BOTTLE, WITH APPLICATOR GEL 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84615-004 POMG PAIN RELIEF ROLLER (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [POMG LLC] 2 Current NDC, 3 package rows 20240929_1fa980fb-fc0e-fdd0-e063-6394a90adc13.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 124 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eagle Medicated MENTHOL METHYL SALICYLATE Eagle Indo Pharma, PT da338796-de9c-be51-e053-2a95a90a2509 2024-10-07 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Eagle Indo Pharma e2c5f821-cdd5-190d-e053-2a95a90a9159 2024-10-07 Warnings Exact identifier application number: M017 NanoXtreme Pain Relieving MENTHOL, METHYL SALICYLATE MG Science Technologies LLC c1490c30-a9db-4120-adaf-9e8000169e46 2024-10-07 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc ea656cf8-cad5-4fa5-82e7-daec77a0bb04 2024-10-07 Warnings Exact identifier application number: M017 Eagle Medicated Oil Refreshing MENTHOL, METHYL SALICYLATE Eagle Indo Pharma, PT e2729023-d689-7ae2-e053-2a95a90a78dc 2024-10-06 Warnings Exact identifier application number: M017 Flanax Back Pain Relief LIDOCAINE Belmora LLC 46d33346-e582-4af1-b81a-feca7033dceb 2024-10-04 Warnings Exact identifier application number: M017 Muscle Balm MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) Natural Essentials, Inc. 16918ba3-2e07-4232-9ed3-4c7751796cd2 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze Pain Relieving Continuous MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 998a4824-9ed9-4fe0-b45b-72e52861fcd3 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze Lidocaine Roll-On LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL Natural Essentials, Inc. 74b06366-5eb4-4eba-aa2b-2b672828294d 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze Lidocaine LIDOCAINE Natural Essentials, Inc. 029bd3fb-1b5b-48e0-b9af-d91d548b5b0f 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze MENTHOL Natural Essentials Inc. a96e3e41-871c-4cf3-93b6-af2a6246ded8 2024-10-04 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 4% CVS 20234356-5e80-b79e-e063-6294a90a2ee3 2024-10-04 Warnings Exact identifier application number: M017 FLANAX BACK PAIN RELIEF LIDOCAINE Belmora Llc af4bf57c-f250-4506-83eb-e0f253e96062 2024-10-04 Warnings Exact identifier application number: M017 topcare hydrocortisone HYDROCORTISONE Topco Associates LLC 11a30ec9-ebc2-4a00-8a8d-431d0d973b37 2024-10-03 Warnings Exact identifier application number: M017 pain relief patch LIDOCAINE 4% Bionpharma Inc. 19c69983-4e78-8ec5-e063-6394a90a84be 2024-10-03 Warnings Exact identifier application number: M017 Good Sense Anti Itch HYDROCORTISONE L. Perrigo Company ecd6d841-40b9-42c9-825d-d172cd04824d 2024-10-03 Warnings Exact identifier application number: M017 Gold Bond Medicated Original Strength Body MENTHOL Navajo Manufacturing Company Inc. f71d598c-92c3-d6fd-e053-6394a90a97d7 2024-10-03 Warnings Exact identifier application number: M017 Signature Care Hydrocortisone HYDROCORTISONE Safeway 9e663535-4acc-4b37-acae-8c17517c5a3d 2024-10-03 Warnings Exact identifier application number: M017 Topcare Hydrocortisone HYDROCORTISONE Topco Associates LLC 849c60fc-e455-4c50-8adf-ac59c0ee785b 2024-10-03 Warnings Exact identifier application number: M017 rexall anti itch maximum strength relief HYDROCORTISONE Dolgencorp, LLC 894cf9ab-693a-4210-96df-605947f51b63 2024-10-03 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84615-004-02 84615000402 1 BOTTLE, WITH APPLICATOR in 1 CARTON (84615-004-02) / 59 mL in 1 BOTTLE, WITH APPLICATOR 2024-08-14 No No Current 84615-004-03 84615000403 90 mL in 1 BOTTLE, WITH APPLICATOR (84615-004-03) 90 ml 2024-08-14 No No Current