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 52 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOMBRA COOL THERAPYMENTHOLSOMBRA COSMETICS INC.87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca32026-04-21WarningsExact identifier
unii: L7T10EIP3A
AlcoholALCOHOLTarget Corporation5c6be1e4-ae02-430c-8ed7-2148660da19d2026-04-21Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
KT Pain Relief Cream Magnesium with Cooling 5% MentholKT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOLClarion Brands LLC4fe64056-f3c6-bc76-e063-6294a90a7e622026-04-20WarningsExact identifier
unii: L7T10EIP3A
4x Medicated Toothache and Gum CreamBENZOCAINECVSa7576238-e7c8-7e86-e053-2995a90aaeb52026-04-20WarningsExact identifier
unii: L7T10EIP3A
Lidothol ES PatchLIDOTHOL ES PATCHDirect_Rx4fe72fca-9689-fff4-e063-6394a90a3ad22026-04-20Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Aemerry Numbing CreamMENTHOL 5%Da Capo Prima LLC4fefddaf-19c8-86b4-e063-6294a90abffc2026-04-20WarningsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)9f991292-bbaa-4f4e-b2cb-059d1a04849e2026-04-20WarningsExact identifier
unii: L7T10EIP3A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEBryant Ranch Prepack8f79b023-9bd1-4bd6-8fd0-f9efe88abec02026-04-20Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Solar Flare Sunlit Holiday Hand Sanitizers (Golden Caramel, Vanilla Solstice, Amber Rose)ALCOHOL SPRAYScent Theory Products LLC4fc170dd-7c6b-b810-e063-6394a90ae61f2026-04-18WarningsExact identifier
unii: 3K9958V90M
Sting Relief SwabBENZOCAINE4 Visions LLC4fc7a356-2f1d-85af-e063-6394a90aec6b2026-04-18WarningsExact identifier
unii: L7T10EIP3A
Smart Care APPLE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3a377d37-28c3-4cd6-8633-8b13464a28ef2026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care MISTLETOE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.24534267-52d9-47c9-bb83-913c3a0f29d12026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care PUMPKIN SPICE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5f7ddccc-58da-4c86-b2b4-9de17e12922d2026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care CANDY CANE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.84b0158c-4450-4a15-a01d-8592ae8c9c162026-04-17WarningsExact identifier
unii: 3K9958V90M
Equate Lidocaine and Menthol Paraben FreeLIDOCAINE 4% PLUS MENTHOL 1%Walmart Stores Inc4fa917de-bc46-0b8d-e063-6294a90a218a2026-04-17WarningsExact identifier
unii: L7T10EIP3A
LidoProLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC4faa515f-6040-d948-e063-6294a90a187f2026-04-17WarningsExact identifier
unii: L7T10EIP3A
Smart Care BOTANIC BLUSH HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.4978df06-8dc2-4dc5-a626-6bcb61e7d0ac2026-04-17WarningsExact identifier
unii: 3K9958V90M
Ice Gel ICE COLD ANALGESICMENTHOLUniversal Distribution Center LLC4f921ced-7722-cba5-e063-6294a90a650b2026-04-16WarningsExact identifier
unii: L7T10EIP3A
Walgreens Cold Therapy Pain Relieving PatchMENTHOLWalgreen Co.41e7574a-348f-8eb8-e063-6294a90a6e902026-04-16WarningsExact identifier
unii: L7T10EIP3A
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLH E Be425bc4c-88c7-48ec-98ef-46b45436a6892026-04-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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