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 20 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stud 100 Male Genital Desensitizer LIDOCAINE Pound International Corp d075656e-b13f-4a1d-bbb6-501e642698d5 2026-05-12 Warnings Exact identifier application number: M017 CeraVe Developed with Dermatologists Itch Relief Moisturizing PRAMOXINE HYDROCHLORIDE L'Oreal USA Products Inc 13ce57d0-b1c5-4685-ad7d-a562d9d8fc86 2026-05-12 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY CVS Pharmacy db6f518d-3a0e-43f8-8d19-7382d9b7ff1c 2026-05-11 Warnings Exact identifier application number: M017 Cool and Heat MENTHOL AMERISOURCE BERGEN f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7 2026-05-11 Warnings Exact identifier application number: M017 Instaflex Extra Strength Pain Relief Cream MENTHOL, METHYL SALICYLATE Healthy Directions, LLC d058c64d-0e4f-45aa-8f52-804961b562e3 2026-05-11 Warnings Exact identifier application number: M017 BonicaEaseX Hot Capsicum Pain Relieving CAPSICUM Planet (Anhui) Pharmaceutical Co.,Ltd ca6e48af-af6d-4808-a576-0319d2080d38 2026-05-11 Warnings Exact identifier application number: M017 BonicaEaseX Pain Relieving Lidocaine LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 7486fe89-a377-4a37-997d-e3bd16b891a7 2026-05-11 Warnings Exact identifier application number: M017 YYSDMVY NUMBING Cream LIDOCAINE 4% NUMBING CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 5195f5ec-8524-77f5-e063-6294a90abdc2 2026-05-11 Warnings Exact identifier application number: M017 Lightning X Burn Relief Gel LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 515eb4cc-63af-c11d-e063-6294a90a13ca 2026-05-09 Warnings Exact identifier application number: M017 Albertson Lidocaine, Menthol Pain Relief Medicated Patch LIDOCAINE AND MENTHOL Safeway dc647647-90ec-6beb-e053-2a95a90a7982 2026-05-09 Warnings Exact identifier application number: M017 5 Elementum Lidocaine Male Genital Desensitizer LIDOCAINE MALE GENITAL DESENSITIZER MSVENTURESGROUP O 514b1738-886e-a95d-e063-6294a90aa707 2026-05-08 Warnings Exact identifier application number: M017 Kroger Muscle Rub Cream MENTHOL, CAMPHOR, METHYL SALICYLATE Kroger Co. 45c8c79a-b4b4-d4be-e063-6394a90a9251 2026-05-08 Warnings Exact identifier application number: M017 Walmart Equate Aloe Sunburn Relief Cooling LIDOCAINE WAL-MART STORES INC. 51540f6b-596f-bc47-e063-6294a90a46ae 2026-05-08 Warnings Exact identifier application number: M017 Capsaicin 0.035% cream CAPSAICIN Medcore LLC 0236e1e4-c26c-4fff-a83b-143ce26d93bf 2026-05-07 Warnings Exact identifier application number: M017 Lidocaine 4% Cream LIDOCAINE Medcore LLC 111cb421-ba3b-4772-ab60-d31eb4183168 2026-05-07 Warnings Exact identifier application number: M017 Lidocaine 5% Cream LIDOCAINE Medcore LLC 15d02b42-bf8b-486a-a081-f6d17cc11ec7 2026-05-07 Warnings Exact identifier application number: M017 JenGufun LIDOCAINE Pain Relief Gel-Patch LIDOCAINE PAIN RELIEF GEL-PATCH Henan Kangdi Medical Devices Co., Ltd. 51363a41-5dcc-6a3b-e063-6294a90a6c27 2026-05-07 Warnings Exact identifier application number: M017 Lidoxi LIDOCAINE T&T Pharma Holdings LLC 513c517e-c098-02aa-e063-6294a90ac8a4 2026-05-07 Warnings Exact identifier application number: M017 Harris Teeter Hydrocortisone HYDROCORTISONE HARRIS TEETER LLC 4e8199f8-96ec-5342-e063-6294a90afb2d 2026-05-07 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 5114cdba-96a1-c399-e063-6294a90aac12 2026-05-06 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