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 48 of 230 · 4,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.bbf967e1-3a10-4e04-b7c5-2fcd80cc51742026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
unii: L7T10EIP3A
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEMeijer, Inc.e11390ec-99a3-4ff1-a3c8-ca909f4f67b52026-02-19Warnings, Adverse reactionsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.41b8d113-59e0-41e3-b852-0ec7541cad802026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.ec4907e1-d31c-4360-97d9-dc094a5a08ac2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.2aacfe5c-36c8-4890-b6c0-a9511346761e2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Aloe Vera GelLIDOCAINE HCL, MENTHOLMeijer, Inc.d0cc06c1-c0d5-42f0-82cd-8b704cbe1f462026-02-19Warnings, Adverse reactionsExact identifier
application number: M017
unii: L7T10EIP3A
unii: V13007Z41A
Tartar controlEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.191f01bb-d580-4e96-89d4-ab736b75c51c2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4b1a0e6f-aa68-421c-e063-6294a90a426e2026-02-18WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Veiurkiu External Analgesic CreamLIDOCAINEBLOOMWELL GARDENS LLC40ec5e6f-13dc-de04-e063-6294a90af5d52026-02-18WarningsExact identifier
application number: M017
External Analgesic Cream with Menthol 5%MENTHOL 5%BLOOMWELL GARDENS LLC402faa27-5305-c73d-e063-6394a90a36f22026-02-18WarningsExact identifier
application number: M017
unii: L7T10EIP3A
PAINGELMENTHOL, METHYL SALICYLATENACOR BUSINESS GROUP LLC4b1d55e2-cf83-ffbd-e063-6294a90ad52f2026-02-18WarningsExact identifier
application number: M017
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTarget Corporation563bdc23-7820-411a-b3c5-16514afc83d22026-02-18Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
cough suppressant and topical analgesicCAMPHOR, EUCALYPTUS OIL, MENTHOLTarget Corporationdf21d9d6-36a9-49cf-a29c-c4a573899bd52026-02-18Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEAdvagen Pharma Ltdae40021b-8df8-4b16-aac0-dcec88f76c7d2026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTarget Corporation55e29b2f-a51f-4473-a022-aa9b921beb872026-02-18Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Alocane Anti-ItchHYDROCORTISONE 1%Quest Products, LLC45252043-d41a-3cdd-e063-6394a90aa9e52026-02-18WarningsExact identifier
application number: M017
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLUnited Natural Foods, Inc. dba UNFIb139e7d6-bf4d-45b9-b7cf-d34e5352095c2026-02-17Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLUnited Natural Foods, Inc. dba UNFId9c48c72-b9df-4b3a-bc56-d887196521e22026-02-17Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLUnited Natural Foods, Inc. dba UNFIcd2b55e5-f69c-425e-84db-d114ba8566722026-02-17Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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