FDA.reportPublic FDA data

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
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
680b40fa-1922-443a-a4b0-7c3f6a2b847dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-913-80Peviderm Pramoxine Hydrocholride 1%222 mL in 1 BOTTLELOTION2222
58980-913-80Peviderm Pramoxine Hydrocholride 1%1 in 1 BOXLOTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-913-80ML - Milliliter58980-9137d00e397-db14-47f8-a67d-cbb7e210a15812024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-913PEVIDERM PRAMOXINE HYDROCHOLRIDE 1% (PRAMOXINE HYDROCHLORIDE) LOTION [STRATUS PHARMACEUTICALS INC]2Current NDC, 2 package rows20241109_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 130 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIDL PAIN RELIEF HEAT THERAPY ROLL-ONPAIN RELIEF HEAT THERAPY ROLL-ONShenzhen Sam Technology Co., Ltd.1d0b7b8f-9e5d-00f7-e063-6394a90af87c2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d0b94ec-f956-dff2-e063-6294a90aca4a2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAYShenzhen Sam Technology Co., Ltd.1d0bf4f9-6b02-6cec-e063-6294a90a36c72024-07-12WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINE HCI 2.0%Trifecta Pharmaceuticals USA, LLC.e5e524cd-bb22-715f-e053-2995a90ab5d32024-07-12WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.1d10e3ca-dc93-8e1a-e063-6394a90a47c02024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.PAIN RELIEF HEAT THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d199826-1b27-b6e7-e063-6394a90a69ad2024-07-12WarningsExact identifier
application number: M017
Tidl Pain Relief Morning Therapy Spray.PAIN RELIEF MORNING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d19d070-3818-73de-e063-6394a90a89582024-07-12WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONE WITH ALOE ANTI ITCHNeilMed Pharmaceuticals Inc.032b9f58-5f64-04dd-e063-6294a90a6bb92024-07-10WarningsExact identifier
application number: M017
Octagon Pain ReliefMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.9926f733-1506-4224-9d70-b1813cd81ec32024-07-08WarningsExact identifier
application number: M017
LidoReal PatchLIDOCAINE AND MENTHOLFORREAL PHARMACEUTICALS LLC19f1c037-b4b8-47b0-b0f9-036691c1d3072024-07-05WarningsExact identifier
application number: M017
Lip Medex Lip BalmPETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.988f97e8-a59f-4bc0-9d71-60607364a6862024-07-01WarningsExact identifier
application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALMMENTHOLL'Oreal USA Products Incd580982f-dda6-4b03-bf84-342b9f2c6d932024-06-29WarningsExact identifier
application number: M017
Lip Medex CherryPETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORMBlistex Inc.fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af82024-06-28WarningsExact identifier
application number: M017
10% Methyl Salicylate Pain Relief Patch10% METHYL SALICYLATEAkron Coating & Adhesives1be1f1ce-3238-a8ed-e063-6294a90a5aed2024-06-27Exact identifier
application number: M017
Genuine First Aid Alcohol Cleansing PadBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.c39c4d80-9718-459f-8ae4-ada043bba5b72024-06-26WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bd5cf69-9a08-5e2e-e063-6394a90a03cd2024-06-26WarningsExact identifier
application number: M017
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation2c0389db-ceb2-422b-9575-bdb8fe649a1e2024-06-26WarningsExact identifier
application number: M017
astoneaHYDROCORTISONEASTONEA LABS PRIVATE LIMITEDde09e859-c5fd-0cc5-e053-2a95a90a147e2024-06-25WarningsExact identifier
application number: M017
HealthWise Pain Relief Lidocaine PatchLIDOCAINE 4%Veridian Healthcare0190196d-5f78-042b-e063-6294a90a37142024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bc1bf83-91ee-ec9d-e063-6394a90a3daf2024-06-25WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58980-913-80589800913801 BOTTLE in 1 BOX (58980-913-80) / 222 mL in 1 BOTTLE1 bottle2024-11-01NoNoCurrent