QC Medicated anti itch

Product NDC
63868-959
11-digit product format
638680959
Labeler code
63868
Product ID
63868-959_28cd0b68-0d27-bc7b-e063-6294a90a53a1
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine hydrochloride, menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Chain Drug Marketing Association
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-07
Substance
MENTHOL; PRAMOXINE HYDROCHLORIDE
Active strength
1; 1 g/100g; 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
QC Medicated anti itch
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
88AYB867L5Internal 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
b5e41e3a-81df-3a63-e053-2a95a90a5839Available 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
63868-959-01QC Medicated anti itch1 in 1 CARTONCREAM12
63868-959-01QC Medicated anti itch28 g in 1 TUBECREAM282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-959-01GM - Gram63868-959a2292b26-9014-4510-a2a5-42f34bab2bfc12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-959QC MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [CHAIN DRUG MARKETING ASSOCIATION]2Current NDC, Legacy NDC, 2 package rows20241210_b5e41e3a-81df-3a63-e053-2a95a90a5839.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 30 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RICHTOFIT RAPID ACTIVE ARTHRITISMENTHOL AND CAMPHORRICHTOFIT LIMITED LIABILITY COMPANY4b1cdab1-3e50-4ec3-e063-6394a90af75e2026-03-12WarningsExact identifier
application number: M017
5Kind DMSO 4 Lidocaine HCl Pain RelievingLIDOCAINE HYDROCHLORIDE, MENTHOL5KIND TRADING LTD67d8d045-7fa0-46c2-8072-645d8823903b2026-03-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4%RAPID AID VIET NAM COMPANY LIMITED4ca541b4-7afe-77c5-e063-6294a90ad6922026-03-10WarningsExact identifier
application number: M017
Lidocaine Cream, 4%LIDOCAINEIPG PHARMACEUTICALS, INC.7775bfdd-7eac-4f09-b83f-fc4a16a245582026-03-10WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4c989283-9a27-e8d2-e063-6294a90a8bfa2026-03-09WarningsExact identifier
application number: M017
Prequel Anti-Itch Solution Medicated CalmingMEDICATED CALMING LOTIONThe Center Brands, LLC419fa45b-992b-676e-e063-6394a90add812026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with borderLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.1fda69f7-2bb6-42fc-bcef-677e7b3d7f012026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for kneeMENTHOL, LAUROCAPRAMPlanet (Anhui) Pharmaceutical Co., Ltd.7577625c-87eb-4639-aeab-8a2ab97033fd2026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.7de99b81-b3b3-49f1-8aa7-2ff42e1b46a42026-03-09WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4%RAPID AID VIET NAM COMPANY LIMITED4ca35030-958c-8f62-e063-6294a90a4d632026-03-09WarningsExact identifier
application number: M017
Welmate Lidocaine Pain Relieving PatchLIDOCAINEYYBA Corpcff71b75-fc4e-29ac-e053-2995a90abd502026-03-06WarningsExact identifier
application number: M017
Heal and Rescue Bunion Pain ReliefLIDOCAINE HCL, MENTHOLRooftop Consumer Health, Inc4c60d4d3-e0a9-6f93-e063-6394a90a16af2026-03-06WarningsExact identifier
application number: M017
JUST CBD - PAIN RELIEFMENTHOL, CAMPHORJust Brands LLC4c493c0b-c58e-cb56-e063-6394a90a93952026-03-05WarningsExact identifier
application number: M017
Hug a BooBoo Medicated booboo WipesBENZOCAINELights Medical Manufacture Co., Ltd.509aaafc-2ef7-4205-818c-7ff5b146e1592026-03-04WarningsExact identifier
application number: M017
CVS Foot PainLIDOCAINE HYDROCHLORIDECVS Pharmacy4c3350c3-2e3e-093c-e063-6394a90a34752026-03-04WarningsExact identifier
application number: M017
Game On SportMENTHOLNatural Essentials, Inc4c3411dc-5378-bd93-e063-6394a90a84062026-03-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llcf4d4a56b-b4b7-9a07-e053-2a95a90ad8532026-03-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llc9987165c-1a0f-dd57-e053-2a95a90ae7352026-03-04WarningsExact identifier
application number: M017
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
application number: M017
Careland Pain Relief Patch PlusLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e32026-03-04WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSNb5e41e3a-81df-3a63-e053-2a95a90a58392
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDb5e41e3a-81df-3a63-e053-2a95a90a58392
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSYb5e41e3a-81df-3a63-e053-2a95a90a58392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-959-01638680959011 TUBE in 1 CARTON (63868-959-01) / 28 g in 1 TUBE1 tube2020-12-070000-00-00NoNoCurrent