FDA.reportPublic FDA data

Anti Itch

Product NDC
67234-008
11-digit product format
672340008
Labeler code
67234
Product ID
67234-008_eba79205-9b9e-495e-a57c-c1d980a90e22
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine Hydrochloride and Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Natureplex LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-02
Substance
PRAMOXINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength
10; 10 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct67234-008UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67234-00867234-008-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Anti Itch
Brand name suffix
Maximum Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/g
MENTHOL, UNSPECIFIED FORM10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1116155Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
75de3d5e-ecbe-4d04-a39d-792200e6ee32Available 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
67234-008-01Anti Itch Maximum Relief42 g in 1 TUBECREAM424
67234-008-01Anti Itch Maximum Relief1 in 1 BOXCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L5ANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
MentholACTIVE MOIETYL7T10EIP3AANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
PramoxineACTIVE MOIETY068X84E056ANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-008ANTI ITCH MAXIMUM RELIEF (PRAMOXINE HYDROCHLORIDE AND MENTHOL) CREAM [NATUREPLEX LLC]3Current NDC, Legacy NDC, 2 package rows20250119_75de3d5e-ecbe-4d04-a39d-792200e6ee32.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 96 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Pain ReliefMENTHOL 10.5%CVSd0ea80ce-38b2-acde-e053-2995a90a47e52025-03-31WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEA2A Integrated Pharmaceuticals, LLC31431866-6fb5-2acd-e063-6294a90ac5202025-03-31WarningsExact identifier
application number: M017
Citrus Cleansing Foot Soak and Body SoakCAMPHORSANSAR, LLCf136616d-9f32-4e55-a495-b7466fd685262025-03-28WarningsExact identifier
application number: M017
Zpol ULTRAMENTHOL, METHYL SALICYLATELaboratorios Zepol S.A.1a1433a6-8d04-96df-e063-6394a90a987b2025-03-27WarningsExact identifier
application number: M017
Muscle Recovery Foot Soak and Body SoakCAMPHORSANSAR, LLC1c347267-b653-41bf-9967-7feff17c38af2025-03-27WarningsExact identifier
application number: M017
Soothing Lavender Foot Soak and Body SoakCAMPHORSANSAR, LLCef26523a-b2f2-466e-89ad-f293cd64decb2025-03-27WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc31408e21-e58d-6db5-e063-6294a90aa4bc2025-03-26WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc3143bb72-2969-d66e-e063-6294a90a46042025-03-26WarningsExact identifier
application number: M017
Parche LeonCAPSAICIN, CAMPHOR, MENTHOLPharmadel LLCa8f266fa-6e43-559e-e053-2995a90a2c752025-03-26WarningsExact identifier
application number: M017
Adellina Numbing CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.314a83fe-8bdb-766f-e063-6294a90a61c62025-03-26WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus Menthol PatchLIDOCAINE AND MENTHOLVeridian Healthcare312f15fe-9297-2dc2-e063-6294a90a6f4d2025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3130729d-1679-90cd-e063-6294a90a21e62025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare31314dda-6199-574d-e063-6394a90aae7a2025-03-25WarningsExact identifier
application number: M017
RWSEFK Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.31366793-f8a6-a2c4-e063-6294a90acbfc2025-03-25WarningsExact identifier
application number: M017
Forticept Wounds and Burns HydrogelBENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELidan, inc.c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f2025-03-25WarningsExact identifier
application number: M017
MQ Pain Relieving PatchPAIN RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0978ff22-c357-e266-e063-6394a90a98a42025-03-24WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHAdvanced Rx of Tennessee, LLC30c97646-db06-df84-e063-6394a90a77432025-03-20WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e572025-03-20WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPFCAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.5f904369-5f21-4907-98de-df23bce308232025-03-20WarningsExact identifier
application number: M017
DermaCort Anti-itchHYDROCORTISONEMelaleuca, Inc.24044b0f-dd1e-4762-82b8-7a28b08c2f772025-03-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN75de3d5e-ecbe-4d04-a39d-792200e6ee324
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD75de3d5e-ecbe-4d04-a39d-792200e6ee324
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY75de3d5e-ecbe-4d04-a39d-792200e6ee324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67234-008-01672340008011 TUBE in 1 BOX (67234-008-01) / 42 g in 1 TUBE1 tube2008-01-020000-00-00NoNoCurrent