FDA.reportPublic FDA data

NDC 58228-2012-01 - PROSTAT FIRST AID Burn Ease, 0.9g

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
58228-2012
Requested NDC
58228-2012-01
Package NDCs from labels
58228-2012-1, 58228-2012-01
Manufacturer
ProStat First Aid LLC | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2025-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
58228-2012-1 Prostat 8610 Burn Ease Burn gel 0.9gProStat First Aid LLC | Nantong Health & Beyond Hygienic Products Inc.2025-10-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-2012-1PROSTAT FIRST AID Burn Ease, 0.9g25 in 1 BOXGEL251
58228-2012-1PROSTAT FIRST AID Burn Ease, 0.9g900 in 1 CARTONGEL9001

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 116 of 228 · 4,545 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AsperFlex AdvanceCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.d23d7f2b-4dcd-4c31-9d12-340f233018b42025-10-01WarningsExact identifier
application number: M017
unii: L7T10EIP3A
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC4024d604-c8c7-2d73-e063-6294a90a2e802025-10-01WarningsExact identifier
application number: M017
unii: L7T10EIP3A
DR AMIN JAVID Botanical-Complex Pain-Relieving Balm, 30 ml/1.0 fl ozMENTHOL, CAMPHOR, METHYL SALICYLATE, CAPSICUM OLEORESIN (CONTAINING CAPSAICIN)BH GLOBAL HOLDINGS LLC1ddddbb6-2d01-c894-e063-6394a90acd582025-10-01WarningsExact identifier
application number: M017
Tylenol Precise Pain Relieving Lidocaine 4%LIDOCAINEKenvue Brands LLC36a95afd-97e5-2271-e063-6394a90aea182025-09-30WarningsExact identifier
application number: M017
Original Extra Strong All Natural Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf2025-09-30WarningsExact identifier
unii: L7T10EIP3A
Xpect First Aid CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLCintas Corporationf7112e5d-c8c4-42ad-8a65-24bfc32d4aea2025-09-30WarningsExact identifier
unii: V13007Z41A
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Capsaicin HeatCAPSAICINUniversal Distribution Center LLCb3b40f77-3b0b-4111-968b-f3a87a5701fa2025-09-29WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSHenry Schein, Inc.bb53bb10-bb36-4c9b-b632-71455615f9f32025-09-29Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.ee21518e-b3ed-405a-ac3b-bfe753893dba2025-09-29Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Caring Mills Menthol 4% Roll-OnMENTHOLVeridian Healthcaref4308c74-0860-4265-aeaf-a01301cca27a2025-09-29WarningsExact identifier
application number: M017
unii: L7T10EIP3A
COLD AND HOT MEDICATED LARGEMENTHOLUniversal Distribution Center LLCd6780230-aa96-4055-b054-be41358568b62025-09-29WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSHenry Schein, Inc.a5d4b206-cc53-470f-9bca-abfc6ea5cc992025-09-29Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
COLD AND HOT MEDICATEDMENTHOLUniversal Distribution Center LLCc19aa620-401d-43c4-804c-3611cc39e9f22025-09-29WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Lidocaine HydrochlorideLIDOCAINEHenry Schein, Inc.0c0790ec-effd-4d8a-9874-8ca0b31e54d02025-09-29Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
UniShield First Aid BurnLIDOCAINE HCLUnishieldf729c557-da4b-3fb5-e053-6394a90a41962025-09-28WarningsExact identifier
application number: M017
unii: V13007Z41A
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Xpect HydrocortisoneHYDROCORTISONECintas Corporation45ef9be4-54c4-4d85-966b-27708313ded42025-09-26WarningsExact identifier
application number: M017
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD3fb16579-7cf1-873a-e063-6294a90a9ac12025-09-26WarningsExact identifier
unii: 9E8X80D2L0
Zhuifeng Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3f12da60-26d1-4407-8e02-c3213ea3ad2a2025-09-26WarningsExact identifier
application number: M017
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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