FDA.reportPublic FDA data

NDC 58443-0648 - Panama Jack Burn Relief Gel with Lidocaine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58443-0648
Package NDCs from labels
58443-0648-4
Manufacturer
Prime Enterprises Inc.
Effective date
2024-05-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Panama Jack Burn Relief Gel with Lidocaine - Prime Enterprises Inc.Prime Enterprises Inc.2024-05-02HUMAN OTC DRUG LABEL

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 78 of 293 · 5,854 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc3006971b-784c-43fd-91a6-d96876bbf1852026-02-23WarningsExact identifier
unii: L7T10EIP3A
Scent Theory Hand Sanitizers Cherry Pop, Ocean Splash, Juicy PearALCOHOLScent Theory Products LLC4b865d82-71c3-1023-e063-6294a90ac7742026-02-23WarningsExact identifier
unii: 3K9958V90M
NeuroFreezeMENTHOLBlue Heron Pharmaceuticals, LLCbb8aba0a-2378-4eb5-b51e-22957586480b2026-02-23WarningsExact identifier
unii: L7T10EIP3A
NeuroSootheCAMPHOR, MENTHOLBlue Heron Pharmaceuticals, LLCe3c21cdb-0027-486b-9b83-c1261c3e73a62026-02-23WarningsExact identifier
unii: L7T10EIP3A
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.cf723c7b-495d-4bae-942c-561cf28af2d32026-02-21WarningsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDEBaxter Healthcare Corporationf21512ea-c7c3-4766-b976-b2c0b5616bf02026-02-20Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Advanced Hand SanitizerADVANCED HAND SANITIZERChain Drug Marketing Association49a1001c-8f4e-d0e7-e063-6394a90a53062026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLChain Drug Marketing Associationa85d93f2-e6f0-4fad-9ff7-6cbb62942bb22026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Swiftalyn Numbing CreamMENTHOL 1%GENUINE INNOVATION LTD4b2ebff2-2f50-e54b-e063-6294a90aaccb2026-02-19WarningsExact identifier
unii: L7T10EIP3A
Equate Cold Therapy Pain RelievingMENTHOLWalmart Inc46a3c9e9-5cd3-4bc4-e063-6394a90a71782026-02-19WarningsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOLPerrigo Direct, Inc790843ce-88e2-4060-b61f-925fb30272da2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCAYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPerrigo Direct, Inc50776776-80aa-4098-8cf3-6daa0b305b152026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AdvancedETHYL ALCOHOLPerrigo Direct, Inc68eca241-acce-4f12-9643-bec9b14f53d02026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPerrigo Direct, Inccb4cf304-4f19-40cd-b480-9d89d19096842026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.bbf967e1-3a10-4e04-b7c5-2fcd80cc51742026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.41b8d113-59e0-41e3-b852-0ec7541cad802026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Advanced Hand SanitizerETHYL ALCOHOLMeijer, Inc.a56b4a66-3923-4e40-a461-1d97043fb89a2026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.ec4907e1-d31c-4360-97d9-dc094a5a08ac2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.2aacfe5c-36c8-4890-b6c0-a9511346761e2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.