Home NDC 69452-393 pain relief roll-on
Product NDC 69452-393
11-digit product format 694520393
Labeler code 69452
Product ID 69452-393_29f92d33-ff52-1181-e063-6394a90a6211
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine 4%
Dosage form LIQUID
Route TOPICAL
Labeler Bionpharma Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-20
Substance LIDOCAINE HYDROCHLORIDE
Active strength 4 g/100mL
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 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 pain relief roll-on
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1987647 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 69452-393-63 pain relief roll-on 74 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 74 2 69452-393-63 pain relief roll-on 1 in 1 CARTON LIQUID 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-393 PAIN RELIEF ROLL-ON (LIDOCAINE 4%) LIQUID [BIONPHARMA INC.] 2 Current NDC, 2 package rows 20241225_f607b6dc-8d13-604a-e053-2995a90a59ab.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 145 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZIMS MAX FREEZE PRO FORMULA MENTHOL, UNSPECIFIED FORM KOBAYASHI Healthcare International, Inc. 436e8578-b609-4b45-8f84-0d111140fda6 2023-11-16 Warnings Exact identifier application number: M017 ZIMS MAX FREEZE PRO FORMULA MENTHOL KOBAYASHI Healthcare International, Inc. 08dcfa78-7332-4f19-90d7-fdd7d446848a 2023-11-16 Warnings Exact identifier application number: M017 Totally Fun After Sun LIDOCAINE HCL MJ Products Association, LLC 965a2a29-914c-4ad0-b25f-5df3c30da393 2023-11-15 Warnings Exact identifier application number: M017 Universal Ice Cold Analgesic MENTHOL Universal Distribution Center LLC 4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f 2023-11-15 Warnings Exact identifier application number: M017 ZIMS MAX FREEZE PRO FORMULA MENTHOL, UNSPECIFIED FORM KOBAYASHI Healthcare International, Inc. b44beac3-1d20-434f-9a79-4fab1ac68791 2023-11-15 Warnings Exact identifier application number: M017 Universal Ice Cold Analgesic MENTHOL Universal Distribution Center LLC 79ad55eb-b59d-4bb8-88e3-3b51e10a7f28 2023-11-15 Warnings Exact identifier application number: M017 PURE EASE Joint Muscle lnstant Pain Relief CAPSAICIN, MENTHOL SERENU, INC. 42bf129c-5c84-4331-b6d0-78e3be71a985 2023-11-13 Warnings Exact identifier application number: M017 PURE EASE Neur Cream Instant Deep Pain Relief CAPSAICIN, MENTHOL SERENU, INC. e46a4636-6405-440a-a05a-862c354bab54 2023-11-13 Warnings Exact identifier application number: M017 Cryomax Cooling MENTHOL LIFE WEAR TECHNOLOGIES 0a0ae5ba-9fac-45f6-e063-6294a90ad555 2023-11-13 Warnings Exact identifier application number: M017 LBri Super Aloe Stop The Pain METHYL SALICYLATE, MENTHOL, CAPSAICIN L'Bris, Pure 'N Natural 8fb2010c-c34b-4552-858d-a0188ad313ad 2023-11-11 Warnings Exact identifier application number: M017 TOTAL RELIEF HYDROCORTISONE DR. MARDER SKINCARE, LLC 2c05459c-5a2c-45ab-b534-87f966b41681 2023-11-11 Warnings Exact identifier application number: M017 Human Science Muscle Pain Relief METHYL SALICYLATE, MENTHOL Human Science, LLC 4bccc017-264b-11ce-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M017 Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL Village Pharma, LLC 55108ffd-d6a8-41de-e054-00144ff88e88 2023-11-11 Warnings Exact identifier application number: M017 Debbies Down and Dirty Deep Tissue Joint and Muscle MENTHOL DD&D Manufacturing Co., Ltd 531fe834-53e3-305f-e054-00144ff88e88 2023-11-11 Warnings Exact identifier application number: M017 TerraFreeze Pain Relief MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE Beyond Derma, LLC 81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677 2023-11-11 Warnings Exact identifier application number: M017 GOLD ICE Pain Relief MENTHOL Eden's Answers, Inc. a1356c39-42b9-4bd8-a873-bcd40717058b 2023-11-11 Warnings Exact identifier application number: M017 RUBBING DOTS NATURAL COOL PAIN RELIEF MENTHOL Awesome Trading, LLC 137a88ff-e409-4a67-addc-883194c356ae 2023-11-11 Warnings Exact identifier application number: M017 MAXOCAINE Lidocaine Hemp Oil Topical Analgesic LIDOCAINE HYDROCHLORIDE Prime Commerce, LLC 28ed2149-38d2-4062-8442-990a98a69cfc 2023-11-11 Warnings Exact identifier application number: M017 MAXOCAINE PAIN RELIEVING ROLL-ON LIDOCAINE HYDROCHLORIDE, MENTHOL Prime Commerce, LLC c263d5f2-89b9-4dfd-91c8-f894e5f956c9 2023-11-11 Warnings Exact identifier application number: M017 SUGAR BRANDS Rescue Pain Relief and Recovery LIDOCAINE HYDROCHLORIDE Sugar Brands, LLC 74013709-d1d5-4425-825d-eee726718c61 2023-11-11 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69452-393-63 69452039363 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69452-393-63) / 74 mL in 1 BOTTLE, WITH APPLICATOR 2023-02-20 No No Current