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 24 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A Health Itch Relief GelITCH RELIEF GELPharma Nobis, LLC4f80c403-c760-31ec-e063-6394a90a61c92026-04-15WarningsExact identifier
application number: M017
Family Care Antibiotic Pain Relief 0.33ozANTIBIOTIC PAIN RELIEFUnited Exchange Corp4f8405fc-3e38-05d9-e063-6394a90a4cda2026-04-15WarningsExact identifier
application number: M017
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
application number: M017
LavaDerm AfterSunMENTHOLYoung Living Essential Oils, LC.4fcddcf1-36db-2f1a-e054-00144ff8d46c2026-04-15WarningsExact identifier
application number: M017
Arlun Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.4f8b60f9-03e3-e731-e063-6294a90a3b0a2026-04-15WarningsExact identifier
application number: M017
tuiwaro Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.4f66178c-95d9-8c6a-e063-6294a90a2c092026-04-14WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Pharma Nobis, LLC4f6d9a51-c42e-ca88-e063-6394a90a86592026-04-14WarningsExact identifier
application number: M017
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONPharma Nobis, LLC4f6f5a0b-3bfa-289e-e063-6294a90a94b32026-04-14WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINE4 Visions LLC4f76a8c5-fde6-eee0-e063-6394a90a09f82026-04-14WarningsExact identifier
application number: M017
Signature Pain Relief Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4f555b8f-5193-e685-e063-6294a90a7ba22026-04-13WarningsExact identifier
application number: M017
Deep Numbing CreamMENTHOLYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD7943559b-de10-4214-96dc-f9cbac828f462026-04-13WarningsExact identifier
application number: M017
Hydrocortisone Cream 1%HYDROCORTISONE CREAM 1% WITH ALOEPublix Super Markets Inc.3c45a654-7fec-55b3-e063-6294a90a184b2026-04-13WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%AMERISOURCE BERGEN4f5aea1c-ae51-4e1a-e063-6294a90a6aa12026-04-13WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP8465b443-abe9-78fb-e053-2a91aa0ac1d82026-04-13WarningsExact identifier
application number: M017
4JointzMENTHOLARP(USA) Pty Ltd94a5b5f5-abf7-40b3-9dd7-43e2c22f138e2026-04-13WarningsExact identifier
application number: M017
Sumifun Pain Relief CreamsMETHYL SALICLATE CAPSAICIN CAMPHORGuchutang Biotechnology (Longyan) Co., Ltd4f3dd96a-d843-d810-e063-6394a90a188e2026-04-12WarningsExact identifier
application number: M017
BonicaEaseX 24 Hour Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co., Ltd.17fc0cd1-710d-45e6-9513-d7100e3adb422026-04-10WarningsExact identifier
application number: M017
BonicaEaseX Colorless Roll-On Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltdacf460b4-1b41-4b30-a74a-6c3613119d8e2026-04-10WarningsExact identifier
application number: M017
BonicaEaseX Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltd4d84b4fb-8f55-4b2b-b261-858edb7f31442026-04-10WarningsExact identifier
application number: M017
HealthWise Pain Relief Gel PatchCAPSAICIN, MENTHOLVeridian Healthcaref5484151-b6da-4f64-867f-87160a4ec2d62026-04-10WarningsExact 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