Pramoxine Itch relief

Product NDC
51316-141
11-digit product format
513160141
Labeler code
51316
Product ID
51316-141_28f13725-48d9-8774-e063-6394a90a6704
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine HCl 1%
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-25
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
1 g/100g
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
Pramoxine Itch relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 g/100g

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
1052684Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e947694c-c122-0291-e053-2995a90ac39aAvailable 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
51316-141-12Pramoxine Itch relief340 g in 1 JARCREAM3403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-141PRAMOXINE ITCH RELIEF (PRAMOXINE HCL 1%) CREAM [CVS]3Current NDC, 1 package rows20241213_e947694c-c122-0291-e053-2995a90ac39a.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 144 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PURE EASE Neur Cream Instant Deep Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.e46a4636-6405-440a-a05a-862c354bab542023-11-13WarningsExact identifier
application number: M017
Cryomax CoolingMENTHOLLIFE WEAR TECHNOLOGIES0a0ae5ba-9fac-45f6-e063-6294a90ad5552023-11-13WarningsExact identifier
application number: M017
LBri Super Aloe Stop The PainMETHYL SALICYLATE, MENTHOL, CAPSAICINL'Bris, Pure 'N Natural8fb2010c-c34b-4552-858d-a0188ad313ad2023-11-11WarningsExact identifier
application number: M017
TOTAL RELIEFHYDROCORTISONEDR. MARDER SKINCARE, LLC2c05459c-5a2c-45ab-b534-87f966b416812023-11-11WarningsExact identifier
application number: M017
Human Science Muscle Pain ReliefMETHYL SALICYLATE, MENTHOLHuman Science, LLC4bccc017-264b-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M017
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma, LLC55108ffd-d6a8-41de-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M017
Debbies Down and Dirty Deep Tissue Joint and MuscleMENTHOLDD&D Manufacturing Co., Ltd531fe834-53e3-305f-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M017
TerraFreeze Pain ReliefMENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDEBeyond Derma, LLC81dc70b3-7e93-4f9a-ae3a-b50bbfd1a6772023-11-11WarningsExact identifier
application number: M017
GOLD ICE Pain ReliefMENTHOLEden's Answers, Inc.a1356c39-42b9-4bd8-a873-bcd40717058b2023-11-11WarningsExact identifier
application number: M017
RUBBING DOTS NATURAL COOL PAIN RELIEFMENTHOLAwesome Trading, LLC137a88ff-e409-4a67-addc-883194c356ae2023-11-11WarningsExact identifier
application number: M017
MAXOCAINE Lidocaine Hemp Oil Topical AnalgesicLIDOCAINE HYDROCHLORIDEPrime Commerce, LLC28ed2149-38d2-4062-8442-990a98a69cfc2023-11-11WarningsExact identifier
application number: M017
MAXOCAINE PAIN RELIEVING ROLL-ONLIDOCAINE HYDROCHLORIDE, MENTHOLPrime Commerce, LLCc263d5f2-89b9-4dfd-91c8-f894e5f956c92023-11-11WarningsExact identifier
application number: M017
SUGAR BRANDS Rescue Pain Relief and RecoveryLIDOCAINE HYDROCHLORIDESugar Brands, LLC74013709-d1d5-4425-825d-eee726718c612023-11-11WarningsExact identifier
application number: M017
NATURES CRAFT LIDOCAINE Male Genital DesensitizerLIDOCAINE HYDROCHLORIDENatures Design Products LLC61bf1776-5c6c-4307-8348-41fa601640172023-11-11WarningsExact identifier
application number: M017
CLEAN REMEDIES CR PAIN RELIEFMENTHOLClean Remedies, LLCaea9291d-3244-401c-9607-e91107228faa2023-11-11WarningsExact identifier
application number: M017
Arth ArrestMETHYL NICOTINATE, CAPSAICINKey 2 Health, Inc.495034ac-dbf5-4c55-906b-6ffcbcfd5bc22023-11-11WarningsExact identifier
application number: M017
KINETIC ICE Muscle and Joint Pain Relief CreamMENTHOLNo Reason, LLC565f0e20-e534-41db-ba20-e726d578405f2023-11-11WarningsExact identifier
application number: M017
KARMA RUB Elemental Pain ReliefLIDOCAINE HYDROCHLORIDEElemental Bliss LLCc224fb1b-827f-461e-a58f-4020700c3e0d2023-11-11WarningsExact identifier
application number: M017
Bakers Best Arthritis Pain Relief with Hemp SeedHISTAMINE DIHYDROCHLORIDEBaker's Best Health Products, LLC46415d28-99b5-4c9e-bde9-1c703595f6712023-11-11WarningsExact identifier
application number: M017
Dr PAINES Pain ReliefMENTHOLDOCTOR PAINE'S MEDICAL, LLC79d2b332-051e-48c1-afe8-6d4468cd18782023-11-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052684pramoxine HCl 1 % Topical CreamPSNe947694c-c122-0291-e053-2995a90ac39a3
1052684pramoxine hydrochloride 10 MG/ML Topical CreamSCDe947694c-c122-0291-e053-2995a90ac39a3
1052684pramoxine hydrochloride 1 % Topical CreamSYe947694c-c122-0291-e053-2995a90ac39a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-141-1251316014112340 g in 1 JAR (51316-141-12) 340 g2023-04-25NoNoCurrent