Home NDC 58980-913 Peviderm Pramoxine Hydrocholride 1%
Product NDC 58980-913
11-digit product format 589800913
Labeler code 58980
Product ID 58980-913_119ef16e-c873-41df-9e98-4ccade286a85
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine Hydrochloride
Dosage form LOTION
Route TOPICAL
Labeler Stratus Pharmaceuticals Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-01
Substance PRAMOXINE HYDROCHLORIDE
Active strength 1 mg/mL
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 Peviderm Pramoxine Hydrocholride 1%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII 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 58980-913-80 Peviderm Pramoxine Hydrocholride 1% 222 mL in 1 BOTTLE LOTION 222 2 58980-913-80 Peviderm Pramoxine Hydrocholride 1% 1 in 1 BOX LOTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58980-913 PEVIDERM PRAMOXINE HYDROCHOLRIDE 1% (PRAMOXINE HYDROCHLORIDE) LOTION [STRATUS PHARMACEUTICALS INC] 2 Current NDC, 2 package rows 20241109_680b40fa-1922-443a-a4b0-7c3f6a2b847d.zip
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 47 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NUVALU ICE THERAPY MENTHOL PAIN RELIEVING MENTHOL JC SALES 490bc3b1-48bf-5437-e063-6394a90a9018 2026-01-01 Warnings Exact identifier application number: M017 NUVALU ICE THERAPY MENTHOL PAIN RELIEVING MENTHOL NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 5ae00308-0a8c-065c-e063-6394a90aff6b 2026-01-01 Warnings Exact identifier application number: M017 NUVALU ICE THERAPY MENTHOL PAIN RELIEVING MENTHOL NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 4a24e813-6dbc-3fd1-e063-6294a90a4ff0 2026-01-01 Warnings Exact identifier application number: M017 Lidozen Patch LIDOCAINE, MENTHOL Village Pharma LLC d0ec7d25-ad58-46f2-b3b3-f13b4648b0b6 2026-01-01 Warnings Exact identifier application number: M017 FEMININE PAIN RELIEF MENTHOL, UNSPECIFIED FORM BeYou Together Ltd 9636b973-fe7e-481e-a6e9-8070347c0883 2025-12-31 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL FSA Store Inc. 47434af6-0fdd-9615-e063-6394a90ab9e8 2025-12-31 Warnings Exact identifier application number: M017 Winco Lidocaine Pain Patch 4% 5ct LIDOCAINE PAIN PATCH 4% WINCO FOODS, LLC 47439162-fc34-f0d0-e063-6394a90a29ab 2025-12-31 Warnings Exact identifier application number: M017 Pain Relief Patch PAIN RELIEF PATCH QUEST USA CORP. 1ad47834-4f8e-c692-e063-6294a90a7e77 2025-12-31 Warnings Exact identifier application number: M017 Dermagesic PRAMOXINE HCL, ZINC OXIDE, CALAMINE Llorens Pharmaceutical International Division bbff6b53-29da-45c1-8ccd-3e9df7f250e0 2025-12-31 Warnings Exact identifier application number: M017 Dologesic Roll-On LIDOCAINE HCL Llorens Pharmaceutical International Division, Inc. 81546810-85a8-45fe-b9e6-cdd02cc4c080 2025-12-31 Warnings Exact identifier application number: M017 Mentholatum Soothing Vapor Rub Lavender CAMPHOR, EUCALYPTUS OIL, MENTHOL The Mentholatum Company 47473b24-a3e3-2858-e063-6394a90a5920 2025-12-31 Warnings Exact identifier application number: M017 Eucerin Itch Relief Intensive Calming MENTHOL Beiersdorf Inc a7a78af1-1f5a-684d-e053-2a95a90a6ae9 2025-12-31 Warnings Exact identifier application number: M017 Eucerin Skin Calming Itch Relief Treatment MENTHOL Beiersdorf Inc 7e568311-1e6b-9b4b-e053-2991aa0a7b67 2025-12-31 Warnings Exact identifier application number: M017 Steady Freddy LIDOCAINE Medical Symbiosis Pty Ltd caa9eae9-7028-5185-e053-2a95a90ac504 2025-12-31 Warnings Exact identifier application number: M017 HYDROCORTISONE ANTI-ITCH CREAM Water-Jel Technologies 3d34ae31-265a-46bc-a52d-546ea5bb24b6 2025-12-31 Warnings Exact identifier application number: M017 Antibacterial Lidocaine Wound Gel BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Water-Jel Technologies, LLC ef1a6100-7f78-1fdb-e053-2a95a90abf20 2025-12-31 Warnings Exact identifier application number: M017 Kroger Pain Relief Lidocaine Patch LIDOCAINE Kroger Company f6407554-c9a7-24e2-e053-2a95a90aae02 2025-12-30 Warnings Exact identifier application number: M017 Kroger Hot and Cold Medicated Patch MENTHOL Kroger Company 0331c1dd-fe30-421a-85a7-6c6886e7ab27 2025-12-30 Warnings Exact identifier application number: M017 Menthol, Camphor MENTHOL, CAMPHOR Chemco Corporation 472fb097-92e5-c230-e063-6294a90ab33a 2025-12-30 Warnings Exact identifier application number: M017 MENTHOL MENTHOL CHEMCO CORPORATIOM 472fb99c-dcc2-d9a9-e063-6294a90a794c 2025-12-30 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58980-913-80 58980091380 1 BOTTLE in 1 BOX (58980-913-80) / 222 mL in 1 BOTTLE 1 bottle 2024-11-01 No No Current