Home NDC 58228-2012 PROSTAT FIRST AID Burn Ease, 0.9g
Product NDC 58228-2012
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 134 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Burn LIDOCAINE HYDROCHLORIDE JHK Inc 5a4ac4cc-015a-48e7-81f8-93a895049afd 2024-04-25 Warnings Exact identifier application number: M017 Cold Therapy Pain Relief MENTHOL, UNSPECIFIED FORM Walgreen Co. ede15818-5d17-477d-a8be-7b36bb0770a6 2024-04-22 Warnings Exact identifier application number: M017 Anti Itch HYDROCORTISONE Neilmed Pharmaceuticals Inc. 14b4f066-fde4-ac97-e063-6394a90ae64c 2024-04-20 Warnings Exact identifier application number: M017 Walgreens Cold Therapy Pain Relief Patch MENTHOL 5% Walgreens Company e33c90d1-2729-970f-e053-2995a90ad97a 2024-04-18 Warnings Exact identifier application number: M017 HealthWise Cold Therapy Pain Relief Patch MENTHOL Veridian Healthcare 0ce356e0-90a3-ad52-e063-6294a90a404a 2024-04-18 Warnings Exact identifier application number: M017 Walgreens Scalp Relief External analgesic HYDROCORTISONE Walgreen Company da0a24c7-9295-4f22-b2c7-40000dad4b81 2024-04-18 Warnings Exact identifier application number: M017 HealthWise 3x Medicated Pain Relief Patch CAMPHOR,MENTHOL, METHYL SALICYLATE Veridian Healthcare 164d4d62-00c0-e06d-e063-6294a90abd73 2024-04-17 Warnings Exact identifier application number: M017 TIGER Balm PAIN RELIEVING HYDROGEL CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM Haw Par Healthcare Ltd. ca601b02-e9be-4d8d-a384-c62553302ceb 2024-04-16 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 1592a40a-a647-34bd-e063-6394a90a0a10 2024-04-08 Warnings Exact identifier application number: M017 Menticam CAMPHOR, MENTHOL, METHYL SALICYLATE PureTek Corporation 081837a8-9669-be1f-e063-6394a90a9d20 2024-04-05 Warnings Exact identifier application number: M017 Pain Relieving Liniment CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM J.R. Watkins, LLC. 97a0c839-0927-4e54-aee2-ded2016ac4a0 2024-04-02 Warnings Exact identifier application number: M017 HealthWise Capsaicin Heat Patch CAPSAICIN Veridian Healthcare 150c1f09-8aa7-67ea-e063-6294a90a950a 2024-04-01 Warnings Exact identifier application number: M017 HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent LIDOCAINE HCI Veridian Healthcare 150d3e54-5c8d-19ef-e063-6394a90a70c2 2024-04-01 Warnings Exact identifier application number: M017 Meijer Pain Relief Cream LIDOCAINE Meijer Distribution 07ecee44-387a-cdce-e063-6294a90ab9c9 2024-03-27 Warnings Exact identifier application number: M017 Hydrocortisone Cream HYDROCORTISONE Trifecta Pharmaceuticals USA 141aa2a7-8789-1127-e063-6294a90a2d23 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. 1dc21c95-b419-4175-85f8-040b73060d37 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Roll-On Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. d94ae654-ce25-4bff-b9bd-24a0e0e8568a 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. f8bff018-fb4f-47b4-b8f8-4a496aede346 2024-03-20 Warnings Exact identifier application number: M017 Rugby Arthritis Pain Relieving Topical Analgesic CAPSAICIN Rugby Laboratories 8f1bc075-97ac-4154-8768-0d878104c3ba 2024-03-14 Warnings Exact identifier application number: M017 Rugby Ice Blue External Analgesic MENTHOL, UNSPECIFIED FORM Rugby Laboratories 2b65cb6a-4364-4770-b7b9-5c4637edd01a 2024-03-14 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