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 94 of 293 · 5,842 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLMY IMPORTS USA LLC48f2527c-a83e-f709-e063-6394a90aa0302026-01-21WarningsExact identifier
unii: 3K9958V90M
Walgreens SWEET PEA PETALS Hand Sanitizer MistETHYL ALCOHOLWalgreen Co.9867c899-980b-4272-8716-41e7c27cdcb82026-01-21WarningsExact identifier
unii: 3K9958V90M
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hand Sanitizing WipesALCOHOLGerms Be Gone LLC2bd6249b-f215-7aa9-e063-6394a90a65802026-01-20WarningsExact identifier
unii: 3K9958V90M
LIDOCAINE HYDROCHLORIDE AND DEXTROSELIDOCAINE HYDROCHLORIDE AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirst1bf999b5-e290-dcbd-e063-6294a90a2bab2026-01-20Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Equate Pain Relieving Cream LidocaineLIDOCAINEWal-Mart Stores Inc52b91508-22aa-4c4b-94f4-977f14a01dad2026-01-20WarningsExact identifier
unii: V13007Z41A
SPA HAND SANITIZER SUMMER LEMONETHYL ALCOHOLRejoice International Corp.48dd563a-0558-cc76-e063-6294a90ab0412026-01-20WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48de4a31-c620-6c1c-e063-6394a90abb962026-01-20WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar BlossomETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48df981a-74da-a629-e063-6294a90a7f402026-01-20WarningsExact identifier
unii: 3K9958V90M
Smart Care COCO CABANA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.026aff02-33cf-486d-ae7f-0f0913ce83992026-01-20WarningsExact identifier
unii: 3K9958V90M
Walgreens PEAR Hand Sanitizer MistETHYL ALCOHOLWalgreen Co.a89f90e1-0696-4688-9503-5e6b3e7853bd2026-01-20WarningsExact identifier
unii: 3K9958V90M
Smart Care CITRUS SUNSET HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.de33db2f-9329-4c42-b67f-de5358c547aa2026-01-19WarningsExact identifier
unii: 3K9958V90M
SIMPLY VITAL PAIN RELIEF HEMPMENTHOLALPHA PLANTS INCc14f4c06-cfe5-497e-9f9e-b2ba442e61bb2026-01-19WarningsExact identifier
unii: L7T10EIP3A
GRANULOTION HemorrhoidalMENTHOL, ZINC OXIDEGL Health, Inc.1a32741c-5e4a-40e5-b15a-8233c5bdb92b2026-01-19WarningsExact identifier
unii: L7T10EIP3A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution48c18a90-9d53-d200-e063-6394a90a12712026-01-19Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
VAPORXCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLAKRON PHARMA INC51b32162-0c5a-4b5b-999a-34337d8166032026-01-19WarningsExact identifier
unii: L7T10EIP3A
Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker FreezeALCOHOLScent Theory Products LLC48c3d5e9-2d57-5a46-e063-6394a90a07222026-01-19WarningsExact identifier
unii: 3K9958V90M
AsperFlexMENTHOL AND METHYL SALICYLATEAkron Pharma Inc.117de175-976d-44f3-85ed-3d127fbe3a7c2026-01-19WarningsExact identifier
unii: L7T10EIP3A
Equate Pain Relieving Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATEWal-Mart Stores Inc5ed1d7b3-925e-4a18-8e15-636f5b442ad72026-01-19WarningsExact identifier
unii: L7T10EIP3A
HydroseptineZINC OXIDE, MENTHOLAKRON PHARMA INC5359d92e-641e-4076-9d91-18daee58a30e2026-01-19WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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