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 40 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vanilla Salt Air Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC5228794d-0048-bb6d-e063-6394a90acdae2026-05-26WarningsExact identifier
unii: 3K9958V90M
Watermelon Whirl Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC522b6376-bae8-adb0-e063-6294a90a318d2026-05-26WarningsExact identifier
unii: 3K9958V90M
Lidothol ESMENTHOL 5%, LIDOCAINE 4%Advanced Rx of Tennessee, LLC49ef3680-e34e-1fe7-e063-6294a90a959f2026-05-26Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
unii: V13007Z41A
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
unii: V13007Z41A
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
unii: L7T10EIP3A
Smart Care Hand Sanitizer 4pk with Glitter Silicone Case - Watermelon Splash, Mango Papaya, Pineapple Sunrise, Coconut WaterALCOHOLShenzhen Lantern Scicence Co.,Ltd.529f25f9-92eb-b7df-e063-6294a90a8dbc2026-05-25WarningsExact identifier
unii: 3K9958V90M
Elf Hand Sanitizer Gift Set Maple Syrup Drizzle, Peppermint Sugar Rush, Creamy Vanilla SwirlALCOHOLScent Theory Products LLC52aa188f-32b9-684a-e063-6294a90a8d4a2026-05-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Glitter Silicone Case 2pk - Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.529bc4a4-a7e3-dbcc-e063-6294a90a7bca2026-05-24WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Glitter Silicone Case 2pk - Peach BelliniALCOHOLShenzhen Lantern Scicence Co.,Ltd.529c5b79-bb85-0fb5-e063-6294a90ad8a02026-05-24WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 4pk with Silicone Case Cherry Blossom,Gardenia,Lavender Vanilla,Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.529cb9a6-3105-8a45-e063-6294a90ac5c12026-05-24WarningsExact identifier
unii: 3K9958V90M
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.55aa77b8-7601-4432-8631-bfec58daf2472026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.5251a3e8-f499-7775-e063-6294a90a44bf2026-05-21WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.51ae09af-1ce4-2831-e063-6294a90ab6a52026-05-21WarningsExact identifier
unii: 3K9958V90M
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact identifier
unii: L7T10EIP3A
DO ME DELAYLIDOCAINE HCLProdigy Media Inc5255ee85-6f29-0776-e063-6394a90a525b2026-05-21WarningsExact identifier
unii: V13007Z41A
Scentfull Midnight Air Hand SanitizerALCOHOLScent Theory Products LLC52561c01-574a-81e8-e063-6294a90a5f822026-05-21WarningsExact identifier
unii: 3K9958V90M
DEHYDRATED ALCOHOLALCOHOLAccord Healthcare, Inc.07fa92f7-d752-42e3-a572-b552461c43892026-05-21Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
THE WORLD OF Strawberry ShortcakeALCOHOL HAND SANITIZERDongyang Loulee Cosmetics Co.,Ltd.52581a49-181f-7db4-e063-6394a90a46f42026-05-21WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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