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 104 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017
Lidocare Arm, Neck, Leg4% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC59a104ee-7034-99c3-e053-2991aa0a164c2025-01-06WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu Pharmaceutical Co., Inc.4f3a438c-f378-4d2a-a95c-58e56cf1e7972025-01-06WarningsExact identifier
application number: M017
Lidocare 034% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC416ebf5a-2efb-6d0b-e054-00144ff88e882025-01-06WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll-onMENTHOLADP Health Limitede0bb77b2-45ee-45fa-9659-9c7d99bb20dc2025-01-05WarningsExact identifier
application number: M017
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
application number: M017
glo SKIN BEAUTY Remedy GelGLO SKIN BEAUTY REMEDY GELHayden Caleel LLCaa47ff08-07b3-4fd1-bae5-420e4b928f062025-01-05WarningsExact identifier
application number: M017
Capsaicin 0.025% CreamCAPSAICIN 0.025%Puretek Corporation28f00df0-c416-f17b-e063-6294a90a55702025-01-02WarningsExact identifier
application number: M017
AVON HeXashield Pain Relief for Muscle, Back and Joint CreamCAMPHOR, MENTHOL, METHYL SALICYLATETai Guk Pharm. Co., Ltd.8f29ffd7-48b9-109f-e053-2995a90ab2152025-01-01WarningsExact identifier
application number: M017
AVON HeXashield Arthritis Pain Relief Cream CapsaisinCAPSAISINTai Guk Pharm. Co., Ltd.8f286a9d-8765-21b3-e053-2a95a90ae43a2025-01-01WarningsExact identifier
application number: M017
AVON HeXashield Anti Itch Cream with Healing AloeHYDROCORTISONETai Guk Pharm. Co., Ltd.8f2aa11d-d794-6f3e-e053-2995a90a1d9d2025-01-01WarningsExact identifier
application number: M017
HeXashield Anti Itch Cream with Healing AloeHYDROCORTISONETai Guk Pharm. Co., Ltd.b9d033f3-4d12-a2c8-e053-2995a90ac7f12025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Pain Relief with MentholMENTHOLGreen Compass, Inc.0a0c212e-ae5d-8505-e063-6394a90af6222025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.0a0b688e-50f1-3eb1-e063-6394a90a7efa2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Topical PainCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.8cb80362-5d24-1ee3-e053-2a95a90afcdf2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Roll-On Pain ReliefMENTHOLGreen Compass, Inc.b5916aa2-428c-5637-e053-2995a90a08b02025-01-01WarningsExact 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