Home NDC 83833-101 WelAhead by Welmate Lidocaine 5% Roll-on
Product NDC 83833-101
11-digit product format 838330101
Labeler code 83833
Product ID 83833-101_35a93f2b-396d-1532-e063-6394a90a7c83
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine 5%
Dosage form SOLUTION
Route TOPICAL
Labeler OTC PHARM LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-01
Substance LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength 5 g/100mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 83833-101-03 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 83833-101-03 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 83833-101-03 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 83833-101-03 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 83833-101-03 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 83833-101-03 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 83833-101-03 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 WelAhead by Welmate Lidocaine 5% Roll-on
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EC2CNF7XFP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2670601 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83833-101-03 WelAhead by Welmate Lidocaine 5% Roll-on 90 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83833-101 WELAHEAD BY WELMATE LIDOCAINE 5% ROLL-ON (LIDOCAINE 5%) SOLUTION [OTC PHARM LLC] 2 Current NDC, 1 package rows 20250523_0b75e83e-8c7b-6247-e063-6294a90ac413.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 149 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bakers Best Maximum Strength Pain Relief LIDOCAINE HYDROCHLORIDE, MENTHOL Baker's Best Health Products, LLC 9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d 2023-11-06 Warnings Exact identifier application number: M017 BAKERS BEST Pain Relief with Pure Hemp Seed Oil LIDOCAINE HYDROCHLORIDE, MENTHOL BAKER'S BEST HEALTH PRODUCTS, INC. ae54c234-bfe4-4a74-b293-db7efda7884b 2023-11-06 Warnings Exact identifier application number: M017 Arth RX Topical Analgesic METHYL NICOTINATE, CAPSAICIN HCD Sales a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609 2023-11-06 Warnings Exact identifier application number: M017 BAKERS BEST Arthritis Pain Relief Cream with Hemp and Lavender HISTAMINE DIHYDROCHLORIDE BAKER'S BEST HEALTH PRODUCTS, INC. 03ec87c5-6669-4afb-8d9c-c8dc9907495d 2023-11-06 Warnings Exact identifier application number: M017 DOCTORS TOUCH Erase The Pain MENTHOL DOCTOR'S CHOICE MEDICAL, LLC fe9ce2c7-d6af-4dad-b6e6-5049a9e091b0 2023-11-06 Warnings Exact identifier application number: M017 RadiaGuard Advanced Radiation Relief LIDOCAINE HYDROCHLORIDE SMOOTH SIDE, INC 21205087-5a2e-41a5-be40-30cba2895408 2023-11-06 Warnings Exact identifier application number: M017 BLUE SPRING Foot and Leg Comfort MENTHOL ACA MANAGEMENT LLC 5f52218d-eea4-4640-b820-84c077ab98ba 2023-11-06 Warnings Exact identifier application number: M017 EMU THERAPY Red Hot Pepper Pain Relief Cream MENTHOL, CAPSAICIN ACA MANAGEMENT LLC 36293885-b2dd-4fba-9748-35a3c9e05078 2023-11-06 Warnings Exact identifier application number: M017 ROPANA Pain Relief Cream HISTAMINE DIHYDROCHLORIDE FUSION PAIN SOLUTIONS LLC e0342aa3-ca80-40b7-bec6-1b33c4db398b 2023-11-06 Warnings Exact identifier application number: M017 EMU THERAPY Cool Menthol Therapy Pain Relief Cream MENTHOL ACA MANAGEMENT LLC 16894346-3513-41b1-b09f-72d84edcc4ac 2023-11-06 Warnings Exact identifier application number: M017 SKINS DELAY Climax Control Lidocaine LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 0db91010-12f7-4f20-b96c-432915720d5a 2023-11-06 Warnings Exact identifier application number: M017 POWERECT Lidocaine Male Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 42e0c40f-1efd-45ef-815d-53d193d720eb 2023-11-06 Warnings Exact identifier application number: M017 ARTHRO LIFE Instant Pain Relief Cream MENTHOL BIOBEST SERVICES LLC 66eb1a78-6861-4693-b68e-bd4a664fc075 2023-11-06 Warnings Exact identifier application number: M017 PARACTIN QuantumActiv Pain Relief Cream MENTHOL NHR SCIENCE CORP ae2f89cf-120c-4c6f-9e81-4560e6fa0373 2023-11-06 Warnings Exact identifier application number: M017 FISICO Arthrozene Pain Cream MENTHOL FISICO INC. d02c4349-78dd-4672-9582-50124ea9f1e1 2023-11-06 Warnings Exact identifier application number: M017 BRONSON SOOTHE Pain Relief CAPSAICIN BRONSON NUTRITIONALS, LLC cedf8f43-b9a3-4a06-b3a1-cf82668541f8 2023-11-06 Warnings Exact identifier application number: M017 INTIMALE Benzocaine Delay Gel BENZOCAINE SKINS SEXUAL HEALTH LIMITED b845bfd5-ab73-495f-97ef-e959bc6311d9 2023-11-06 Warnings Exact identifier application number: M017 RAPID PAIN-RELIEF TOPICAL LIDOCAINE HYDROCHLORIDE, MENTHOL NORDIC HEALTHY LIVING INC. a06d6aca-9aa2-4bbe-bf77-4c85f1dd7870 2023-11-06 Warnings Exact identifier application number: M017 PURE PERSONAL All Natural Pain Relief Cream MENTHOL PURE PERSONAL CARE, LLC 8f3fb1d0-d238-4b4c-9816-7e335258d71d 2023-11-06 Warnings Exact identifier application number: M017 DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC 89c80a8f-227d-4ec0-9327-683892e73b6a 2023-11-06 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 83833-101-03 83833010103 90 mL in 1 BOTTLE, WITH APPLICATOR (83833-101-03) 90 ml 2023-12-01 No No Current