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 18 of 296 · 5,903 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Assorted Hand Sanitizer MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.57a380f2-2c92-18b3-e063-6394a90ae7702026-07-27WarningsExact identifier
unii: 3K9958V90M
Smart Care Assorted Hand Sanitizer Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.57a3ce42-a3d6-0c3c-e063-6294a90a668a2026-07-27WarningsExact identifier
unii: 3K9958V90M
Smart Care Assorted Hand Sanitizer GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.57a4389e-c4f9-bd9b-e063-6394a90a4c5e2026-07-27WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Pouch-Sweet PeaALCOHOLShenzhen Lantern Scicence Co.,Ltd.57a4be75-f0af-56c5-e063-6294a90aafc92026-07-27WarningsExact identifier
unii: 3K9958V90M
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
unii: L7T10EIP3A
PURELL Advanced Hand Sanitizer Green Certified GelALCOHOLGOJO Industries, LLC575d559d-c60a-7704-e063-6394a90a9c6b2026-07-24WarningsExact identifier
unii: 3K9958V90M
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
unii: V13007Z41A
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsExact identifier
unii: V13007Z41A
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: V13007Z41A
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
unii: L7T10EIP3A
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
unii: L7T10EIP3A
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
unii: L7T10EIP3A
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
unii: L7T10EIP3A
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
unii: L7T10EIP3A
MISTIFY WATERMELON HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bf021-6352-e3fc-e063-6394a90ad6de2026-07-23WarningsExact identifier
unii: 3K9958V90M
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
unii: L7T10EIP3A
Smart Care SUGAR COOKIE HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.b7aac379-90d6-4039-9304-891056b40bc02026-07-22WarningsExact identifier
unii: 3K9958V90M
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
unii: L7T10EIP3A
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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