FDA.reportPublic FDA data

Freds Medicated anti itch

Product NDC
53943-265
11-digit product format
539430265
Labeler code
53943
Product ID
53943-265_0c530ae4-9788-7809-e063-6394a90a143d
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine hydrochloride, menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Discount Drug Mart
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-13
Substance
PRAMOXINE HYDROCHLORIDE; MENTHOL
Active strength
1; 1 g/100g; g/100g
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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53943-265-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53943-265-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53943-265-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53943-265-018dfbde2a14a4…c9ff85d89658…

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
Freds Medicated anti itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 g/100g
MENTHOL1 g/100g

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
8697b932-da5a-717e-e053-2a91aa0afcaeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-265-012023-12-12C16284748780-1ba0f9c33-5871-a910-e053-dadaa90a0b85Discount Drug Mart Medicated Anti itch Cream
53943-265-012021-01-29C16284748780-1ba0f9c33-5871-a910-e053-dadaa90a0b85Discount Drug Mart Medicated Anti itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-265-01Freds Medicated anti itch1 in 1 CARTONCREAM16
53943-265-01Freds Medicated anti itch28 g in 1 TUBECREAM286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-265FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [DISCOUNT DRUG MART]6Current NDC, Legacy NDC, 2 package rows20231213_8697b932-da5a-717e-e053-2a91aa0afcae.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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
application number: M017
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
application number: M017
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
application number: M017
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsExact identifier
application number: M017
POMG PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDE, MENTHOLPOMG LLC1fa980fb-fc0e-fdd0-e063-6394a90adc132026-01-07WarningsExact identifier
application number: M017
Artridon GlucosamineMENTHOL, METHYL SALICYLATEPharmadel LLC73572156-4cce-0669-e053-2991aa0aaecc2026-01-07WarningsExact identifier
application number: M017
HealthWise Cooling Pain ReliefMENTHOLVeridian Healthcare6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd2026-01-07WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-Itch CreamHYDROCORTISONEDLC Laboratories, Inc.16eeec2c-065d-4da0-e063-6294a90a38732026-01-07WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
application number: M017
EARTHS CARE MUSCLE AND JOINT RUBCAMPHORDLC Laboratories, Inc.71e33e06-4dc3-4ead-a122-ff89d93a64de2026-01-07WarningsExact identifier
application number: M017
Amour CBDPAIN RELIEF CREAMSVD Premium Products95b45e79-b1e7-17b2-e053-2995a90a88362026-01-07WarningsExact identifier
application number: M017
Tiger Balm Active MuscleMETHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.845a4ead-f9c0-4009-bcae-b17cd388439b2026-01-07WarningsExact identifier
application number: M017
3X Medicated Toothache and Gum GelBENZOCAINERite Aid996f7989-17ce-5b28-e053-2995a90af8b82026-01-06WarningsExact identifier
application number: M017
QNTAMAX Muscle and Joint Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLQntamax LLC6622b94c-824e-4e84-a8d8-b60bb0b866e22026-01-06WarningsExact identifier
application number: M017
Winco Muscle and Joint Pain Relief Gel 2ozWINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEFWINCO FOODS, LLC47bedf4e-4036-cf43-e063-6394a90a91d62026-01-06WarningsExact identifier
application number: M017
Pain Relief Hot PatchMENTHOL AND CAPSAICINUniversal Distribution Center LLC110bcb16-ef0b-4bc8-8877-173a0494e1ad2026-01-06WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN8697b932-da5a-717e-e053-2a91aa0afcae6
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD8697b932-da5a-717e-e053-2a91aa0afcae6
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY8697b932-da5a-717e-e053-2a91aa0afcae6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53943-265-01539430265011 TUBE in 1 CARTON (53943-265-01) / 28 g in 1 TUBE1 tube2014-04-13NoNoCurrent