Home NDC 58228-2012-1 PROSTAT FIRST AID Burn Ease, 0.9g
Product NDC 58228-2012
Requested package NDC 58228-2012-1
11-digit product format 582282012
Labeler code 58228
Product ID 58228-2012_401216de-924e-7a0a-e063-6394a90ac498
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE
Dosage form GEL
Route TOPICAL
Labeler ProStat First Aid LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-30
Substance LIDOCAINE HYDROCHLORIDE
Active strength 2 g/100g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PROSTAT FIRST AID Burn Ease, 0.9g
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1011852 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58228-2012-1 PROSTAT FIRST AID Burn Ease, 0.9g 25 in 1 BOX GEL 25 1 58228-2012-1 PROSTAT FIRST AID Burn Ease, 0.9g 900 in 1 CARTON GEL 900 1
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 68 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aulief Topical Pain Reliever MENTHOL AND CAMOHOR China-Gel, LLC 8647dcc3-1dbc-1093-e053-2991aa0a1ab9 2025-11-04 Warnings Exact identifier application number: M017 China-Gel Topical Pain Reliever MENTHOL AND CAMOHOR (SYNTHETIC) China-Gel, LLC 254abae9-ef1b-5a90-e054-00144ff88e88 2025-11-04 Warnings Exact identifier application number: M017 Pain Relief Gel-Tube MENTHOL Bullet point LLC 42c93789-9758-54b7-e063-6394a90ac398 2025-11-04 Warnings Exact identifier application number: M017 Tattoo care TATTOO CARE CREAM Perfso (HK) Co., Limited 42d0f56f-9cb1-8e19-e063-6394a90aa3e0 2025-11-04 Warnings Exact identifier application number: M017 CORE RELIEF CAMPHOR, MENTHOL Copper Joint, LLC 42d17270-f58d-9d69-e063-6294a90a4078 2025-11-04 Warnings Exact identifier application number: M017 Lidocaine and Menthol LIDOCAINE AND MENTHOL Marcella Health d25f25ee-79f8-49e7-9715-0aae305b73e5 2025-11-03 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS NO TOUCH SPRAY Premier Brands of America Inc. 36481d67-2346-470b-e063-6294a90aae99 2025-11-03 Warnings Exact identifier application number: M017 Lidocaine Numbing Cream LIDOCAINE 5% YYBA Corp 1319ee69-8b3f-5815-e063-6294a90a5ad5 2025-11-03 Warnings Exact identifier application number: M017 Goodsense Extra Strength Cold and Hot Medicated MENTHOL Geiss, Destin and Dunn, Inc. 7585d111-775f-4fb6-a485-28cd99d88852 2025-10-31 Warnings Exact identifier application number: M017 Topcare Cold and Hot Medicated MENTHOL Topco Associates LLC 8739aedd-165c-5ae0-e053-2a91aa0afcd0 2025-10-31 Warnings Exact identifier application number: M017 CVS Medicated Heat 1 ct CAPSAICIN CVS Pharmacy, Inc. d41dce5b-e698-4930-8869-040b2a973f25 2025-10-31 Warnings Exact identifier application number: M017 Coralite Medicated Heat CAPSAICIN United Exchange Corp. a0b89c7e-80bc-43c4-840c-5fd567f60b21 2025-10-31 Warnings Exact identifier application number: M017 Dragon with Arnical Pain Relief MENTHOL Genomma Lab USA Inc. b4cbb7b6-cb71-9721-e053-2995a90a2b2c 2025-10-31 Warnings Exact identifier application number: M017 Gemachlich ZuHause NEUROPATHY SOLID Ointment. GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT. Guangdong Quadrant Ecological Technology Co., Ltd. 425b1b9d-c33a-05e9-e063-6394a90a97a6 2025-10-30 Warnings Exact identifier application number: M017 Gemachlich ZuHause NEUROPATHY Spray. GEMACHLICH ZUHAUSE NEUROPATHY SPRAY. Guangdong Quadrant Ecological Technology Co., Ltd. 425b8259-af38-8d68-e063-6394a90a1120 2025-10-30 Warnings Exact identifier application number: M017 Family Care Muscle and Joint MENTHOL United Exchange Corp. 959af9f4-7188-91a1-e053-2995a90a4665 2025-10-30 Warnings Exact identifier application number: M017 CVS Maximum Strength Boil Relief BENZOCAINE CVS Pharmacy, Inc. 0761b866-af34-42bd-adc9-3d229170d01c 2025-10-30 Warnings Exact identifier application number: M017 CVS Cold and Hot MENTHOL CVS Pharmacy a44ca52d-fec8-0e8c-e053-2995a90a2e60 2025-10-30 Warnings Exact identifier application number: M017 CVS CAPSAICIN CAPSAICIN CVS PHARMACY 9b551fe3-3842-482a-9042-63de5ad39884 2025-10-30 Warnings Exact identifier application number: M017 TopCare Health Pain Relief MENTHOL, CAMPHOR, AND METHYL SALICYLATE Topco Associates LLC dac364ef-6dcd-3fc6-e053-2a95a90a9bb2 2025-10-30 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58228-2012-1 58228201201 900 BOX in 1 CARTON (58228-2012-1) / 25 PACKET in 1 BOX / .9 g in 1 PACKET 900 box 2025-09-30 No No Current