FDA.reportPublic FDA data

DerMend Moisturizing Anti-Itch

Product NDC
0496-0586
11-digit product format
004960586
Labeler code
0496
Product ID
0496-0586_297a5495-6a56-857c-e063-6394a90a531e
Type
HUMAN OTC DRUG
Nonproprietary name
pramoxine hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Ferndale Laboratories, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-01
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
10 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
DerMend Moisturizing Anti-Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246075Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
14c7fb1c-a310-4b12-ab2e-7f1c0801995cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0496-0586-08DerMend Moisturizing Anti-Itch237 mL in 1 BOTTLELOTION2372

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0496-0586-08ML - Milliliter0496-058626637a40-a1c1-429f-8fdc-e653eff6293412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0496-0586DERMEND MOISTURIZING ANTI-ITCH (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20241219_14c7fb1c-a310-4b12-ab2e-7f1c0801995c.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 63 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
After Bite OutdoorDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands22b891a9-6386-dee1-e063-6394a90a5c2f2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger3f881349-fcdd-e276-e063-6394a90ae49e2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434cb8b2-a996-5360-e063-6394a90ada032025-11-13WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED4360e3ec-7a4b-b28e-e063-6294a90a0bd62025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED4360e3be-0ec4-cd57-e063-6394a90aca632025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED43616ad7-58bb-e5ad-e063-6394a90a192b2025-11-13WarningsExact identifier
application number: M017
4x Medicated Severe Toothache and Gum GelBENZALKONIUM CHLORIDEMeijer97ce7890-5093-1763-e053-2a95a90afae72025-11-13WarningsExact identifier
application number: M017
Pain RelieverCAMPHOR, MENTHOLKool 'N Fit Inc.2253f6bd-5707-b993-e063-6394a90aa74a2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED4360e0d1-46cd-ab4b-e063-6394a90a55e12025-11-12WarningsExact identifier
application number: M017
CVS Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECVS8723e097-296f-784a-e053-2991aa0a552e2025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154d8821-3e76-b0e2-e063-6294a90ae0772025-11-12WarningsExact identifier
application number: M017
Good neighbor Pharmacy Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEAMERISOURCEBERGEN DRUG CORPORATION87395273-380c-7cef-e053-2991aa0a54c62025-11-12WarningsExact identifier
application number: M017
Quality Choice Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEChain Drug Marketing Association8735b298-83f3-0b5d-e053-2a91aa0a82922025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.1550e794-b3c0-4769-e063-6294a90a8c2d2025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154fd46e-f00d-1772-e063-6394a90aba7d2025-11-12WarningsExact identifier
application number: M017
Best Choice Itch StoppingDIPHENHYDRAMINE HCLValu Merchandisers884cfd64-2cd1-8c12-e053-2995a90a89252025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLCVS8839149d-e6d5-57cc-e053-2995a90a98322025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLChain Drug Marketing Association884c9b47-d511-1d17-e053-2995a90a42eb2025-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246075pramoxine HCl 1 % Topical LotionPSN14c7fb1c-a310-4b12-ab2e-7f1c0801995c2
1246075pramoxine hydrochloride 10 MG/ML Topical LotionSCD14c7fb1c-a310-4b12-ab2e-7f1c0801995c2
1246075pramoxine hydrochloride 1 % Topical LotionSY14c7fb1c-a310-4b12-ab2e-7f1c0801995c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0496-0586-0800496058608237 mL in 1 BOTTLE (0496-0586-08) 237 ml2017-03-010000-00-00NoNoCurrent