FDA.reportPublic FDA data

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 62 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch EraserDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands2204e135-6a23-68a2-e063-6394a90ac0192025-11-18WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpc8594e10-661f-6ff3-e053-2995a90ab4fc2025-11-18WarningsExact identifier
application number: M017
Mag 5 PT Cooling Formula Recovery CreamMENTHOLRENU LABORATORIES, LLCa45cde67-64ec-643b-e053-2a95a90a10b62025-11-18WarningsExact identifier
application number: M017
After Ivy WipeCAMPHORTender Corporation d/b/a Adventure Ready Brands21d98018-826a-1d0d-e063-6294a90a0a712025-11-17WarningsExact identifier
application number: M017
Itch Eraser GelDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands223c7cfd-6dc5-140a-e063-6394a90a83322025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
application number: M017
AY BENDITO - CBDCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC04b1d605-60aa-56f4-e063-6294a90ae7602025-11-17WarningsExact identifier
application number: M017
AY BENDITO - CBDCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC0f1406fe-3a2f-bf36-e063-6294a90a7e5e2025-11-17WarningsExact identifier
application number: M017
AY BENDITO CBDMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC30a1c6b7-e37e-32c2-e063-6394a90aa3542025-11-17WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000MENTHOL, CAMPHORWorldwide Cosmetics, Inc0816cc8f-8d0b-de27-e063-6294a90a8a9d2025-11-17WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLCf6538e3e-4663-679c-e053-2995a90a87b52025-11-17WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLCf65455d7-04a9-6217-e053-2995a90a7c902025-11-17WarningsExact identifier
application number: M017
JUST CBD - CBD AND THC ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLCf664eb79-8897-3a49-e053-2995a90a37b42025-11-17WarningsExact identifier
application number: M017
JUST CBD RELIEF SOOTHINGLIDOCAINE HCLJust Brands LLCf9aff6e7-5702-f61c-e053-6294a90aa66f2025-11-17WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC0abece07-976c-4881-e063-6294a90a5c1b2025-11-17WarningsExact identifier
application number: M017
Blue-Emu Thrive Pain Relief CreamTRIPELENNAMINE 0.5%Kingsway Pharmaceuticals dba NFI, LLCa4ba6787-c99b-4bf2-9f8f-e923ef9762122025-11-14WarningsExact identifier
application number: M017
CVS Cooling PatchMENTHOLCVS Pharmacy42d97e29-f32d-a31b-e063-6394a90a88d82025-11-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINEMarlex Pharmaceuticals Inc4de2bc60-dc4a-4417-984f-eabab0e926a62025-11-14WarningsExact identifier
application number: M017
EXTREME EMUMENTHOL, METHYL SALICYLATERenu Laboratories, LLC4393b57b-1e70-b8dd-e063-6294a90ae7482025-11-14WarningsExact 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