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 23 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kevo-ProphenJUNIPER TARFaeve, LLC4fe773a8-77cd-831e-e063-6294a90ae2ca2026-04-20WarningsExact identifier
application number: M017
BeeVenomMETHYL SALICYLATEMenper Distributors, Inc.4fe7a986-336d-ad4e-e063-6294a90a0b8a2026-04-20WarningsExact identifier
application number: M017
BenzodentBENZOCAINEFocus Consumer Healthcare, LLC5fdcb871-d387-6352-e053-2991aa0a09da2026-04-20WarningsExact identifier
application number: M017
Tecnu CalagelDIPHENHYDRAMINE HYDROCHLORIDETec Laboratories Inc.8bc9cbfe-1dd4-18ed-e053-2a95a90a79662026-04-20WarningsExact identifier
application number: M017
Aemerry Numbing CreamMENTHOL 5%Da Capo Prima LLC4fefddaf-19c8-86b4-e063-6294a90abffc2026-04-20WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINE4 Visions LLC4fc7a356-2f1d-85af-e063-6394a90aec6b2026-04-18WarningsExact identifier
application number: M017
Equate Lidocaine and Menthol Paraben FreeLIDOCAINE 4% PLUS MENTHOL 1%Walmart Stores Inc4fa917de-bc46-0b8d-e063-6294a90a218a2026-04-17WarningsExact identifier
application number: M017
LidoProLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC4faa515f-6040-d948-e063-6294a90a187f2026-04-17WarningsExact identifier
application number: M017
Coleman Bite and Sting ReliefEXTERNAL ANESTHETIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4fadf1f1-478a-5104-e063-6294a90a10cb2026-04-17WarningsExact identifier
application number: M017
Ice Gel ICE COLD ANALGESICMENTHOLUniversal Distribution Center LLC4f921ced-7722-cba5-e063-6294a90a650b2026-04-16WarningsExact identifier
application number: M017
Walgreens Capsaicin Hot PatchCAPSAICINWalgreen Co.41e959d8-f6ac-f5b4-e063-6294a90abd962026-04-16WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relieving PatchMENTHOLWalgreen Co.41e7574a-348f-8eb8-e063-6294a90a6e902026-04-16WarningsExact identifier
application number: M017
Coleman Sting and Bite ReliefEXTERNAL ANALGESIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4f94ab35-3099-716c-e063-6294a90a8bea2026-04-16WarningsExact identifier
application number: M017
Kroger Witch HazelWITCH HAZELKroger Co.461407d0-fbf6-47e9-e063-6394a90a9a832026-04-16WarningsExact identifier
application number: M017
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.86fe4e8c-5279-445a-a19a-e694eac785fd2026-04-16WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.4503208f-2808-4727-8066-c431230bd70b2026-04-16WarningsExact identifier
application number: M017
EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ONMENTHOLTROY MANUFACTURING, INC895896dc-0762-40a7-8313-cca10ce689842026-04-16WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5%MENTHOLVeridian Healthcare4f9b1b2d-1acc-e0a7-e063-6394a90aadbc2026-04-16WarningsExact identifier
application number: M017
Lidoease 2%LIDOCAINE HCL 2%PureTek Corporation3ba0c0ff-0f7a-7a29-e063-6294a90a547a2026-04-16WarningsExact identifier
application number: M017
Walgreens Lidocaine Pain Relieving Patch AssortedLIDOCAINEWalgreen Co.41e98f15-669f-4543-e063-6294a90a1ef72026-04-15WarningsExact 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