FDA.reportPublic FDA data

ITCH X

Product NDC
0225-0495
11-digit product format
002250495
Labeler code
0225
Product ID
0225-0495_2888be26-0ebc-ab78-e063-6394a90ada63
Type
HUMAN OTC DRUG
Nonproprietary name
BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
BF ASCHER AND CO INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-19
Substance
BENZYL ALCOHOL; PRAMOXINE HYDROCHLORIDE
Active strength
10; 1 g/100g; g/100g
Pharmacologic classes
Pediculicide [EPC]
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
ITCH X
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZYL ALCOHOL10 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
LKG8494WBHInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293632Internal RxNorm lookup
1293634Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03c16d33-8f59-0184-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0225-0495-33ITCH X35.4 g in 1 TUBEGEL35.46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0225-0495-33GM - Gram0225-0495adf96dec-94ed-41d3-b853-e9b2a1ce7e4712014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZYL ALCOHOLACTIVE INGREDIENTLKG8494WBHITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
BENZYL ALCOHOLACTIVE MOIETYLKG8494WBHITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
PRAMOXINEACTIVE MOIETY068X84E056ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
ALOEINACTIVE INGREDIENTV5VD430YW9ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
EDETOLINACTIVE INGREDIENTQ4R969U9FRITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1
WATERINACTIVE INGREDIENT059QF0KO0RITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0225-0495ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]6Current NDC, Legacy NDC, 1 package rows20241208_03c16d33-8f59-0184-e054-00144ff8d46c.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 43 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLT 2LIDOCAINE HCLCENTURA PHARMACEUTICALS INC41dc85ec-d79b-0a32-e054-00144ff8d46c2026-01-12WarningsExact identifier
application number: M017
Mineral Ice Pain RelievingMENTHOLCrown Laboratories7b30076a-0af6-2f74-e053-2a91aa0ae08d2026-01-12WarningsExact identifier
application number: M017
SarnaPRAMOXINE HYDROCHLORIDECrown Laboratories19b0ce1b-e147-01a1-e063-6394a90af8082026-01-12WarningsExact identifier
application number: M017
SarnaPRAMOXINE HYDROCHLORIDE, MENTHOLCrown Laboratories, Inc19c41e75-a654-90cf-e063-6394a90a7e972026-01-12WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEHY-VEE, INC48350b54-8d9a-48c4-e063-6394a90ac0402026-01-12WarningsExact identifier
application number: M017
LidoPlus Pain ReliefLIDOCAINE HYDROCHLORIDECentura Pharmaceuticals, Inc07bacc6c-60a6-4297-8663-904a22bdc0402026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf1efb51c-5217-4cb2-e053-2a95a90a7f952026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf2277e27-868b-57ef-e053-2a95a90abf282026-01-12WarningsExact identifier
application number: M017
BLT 3TETRACAINECENTURA PHARMACEUTICALS INC401a0d22-1181-02ac-e054-00144ff88e882026-01-12WarningsExact identifier
application number: M017
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.0c901f64-6890-45c0-9ca7-ee9de87903c42026-01-12WarningsExact identifier
application number: M017
Goodsense Oral Pain ReliefBENZOCAINEGeiss, Destin and Dunn, Inc.eb461b70-d10f-4e11-8374-e43713f3504d2026-01-12WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM AND MENTHOLSaje Natural Business Incf516e416-446b-8f21-e053-2a95a90afd882026-01-12WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.3df0e56a-7651-42dc-8ed8-f68836a63c612026-01-12WarningsExact identifier
application number: M017
Trauma LessMENTHOLSaje Natural Business Inc.650cba4c-6aba-48c3-9c41-841f199055482026-01-12WarningsExact identifier
application number: M017
MamisanLIDOCAINE HYDROCHLORIDE, MENTHOLMiramar Cosmetics, Inc DBA Miramar Lab4402e900-c6e9-4f32-8cc4-c84014384a9f2026-01-12WarningsExact identifier
application number: M017
Curist Lidocaine PatchLIDOCAINE 4% PATCHLittle Pharma, Inc.1a8fe44e-7a21-c2ab-e063-6394a90a61002026-01-11WarningsExact identifier
application number: M017
DG Health Pain RelievingLIDOCAINE HCLDOLGENCORP, LLC923aeb4c-049f-4ecc-a77e-9ffa0e236d4e2026-01-11WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare46b84e0b-78a9-4cde-9f90-e165b54191622026-01-09WarningsExact identifier
application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-OnMENTHOLInspec Solutions12ff9b9a-73e5-ce31-e063-6294a90aeaf82026-01-09WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bb0278c9-eaff-d435-e053-2995a90a202a2026-01-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293634Itch-X 10 % / 1 % Topical GelPSN03c16d33-8f59-0184-e054-00144ff8d46c6
1293632pramoxine HCl 1 % / benzyl alcohol 10 % Topical GelPSN03c16d33-8f59-0184-e054-00144ff8d46c6
1293634benzyl alcohol 0.1 ML/ML / pramoxine hydrochloride 0.01 MG/MG Topical Gel [Itch-X]SBD03c16d33-8f59-0184-e054-00144ff8d46c6
1293632benzyl alcohol 0.1 ML/ML / pramoxine hydrochloride 0.01 MG/MG Topical GelSCD03c16d33-8f59-0184-e054-00144ff8d46c6
1293632benzyl alcohol 10 % / pramoxine hydrochloride 1 % Topical GelSY03c16d33-8f59-0184-e054-00144ff8d46c6
1293634Itch-X (benzyl alcohol 10 % / pramoxine hydrochloride 1 % ) Topical GelSY03c16d33-8f59-0184-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0225-0495-330022504953335.4 g in 1 TUBE (0225-0495-33) 35.4 g2014-09-190000-00-00NoNoCurrent