FDA.reportPublic FDA data

ITCH-X

Product NDC
0225-0516
11-digit product format
002250516
Labeler code
0225
Product ID
0225-0516_ec8208ae-21d5-51d7-e053-2a95a90ad50d
Type
HUMAN OTC DRUG
Nonproprietary name
PRAMOXINE HCL/BENZYL ALCOHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
BF ASCHER AND CO INC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-09-19
Marketing end
2025-10-31
Substance
BENZYL ALCOHOL; PRAMOXINE HYDROCHLORIDE
Active strength
10 g/100mL; g/100mL
Pharmacologic classes
Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0225-0516DDiscontinued by firm2026-10-05
excluded packagepackage0225-05160225-0516-51DDiscontinued by firm2026-10-05

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
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0225-0516DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0225-05160225-0516-51DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0225-0516-51ML - Milliliter0225-0516a05d994c-b6b2-46b7-a291-6fe42b34d0e612014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZYL ALCOHOLACTIVE INGREDIENTLKG8494WBHITCH-X (PRAMOXINE HCL/BENZYL ALCOHOL) SPRAY [BF ASCHER AND CO INC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5ITCH-X (PRAMOXINE HCL/BENZYL ALCOHOL) SPRAY [BF ASCHER AND CO INC]1
BENZYL ALCOHOLACTIVE MOIETYLKG8494WBHITCH-X (PRAMOXINE HCL/BENZYL ALCOHOL) SPRAY [BF ASCHER AND CO INC]1
PRAMOXINEACTIVE MOIETY068X84E056ITCH-X (PRAMOXINE HCL/BENZYL ALCOHOL) SPRAY [BF ASCHER AND CO INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MITCH-X (PRAMOXINE HCL/BENZYL ALCOHOL) SPRAY [BF ASCHER AND CO INC]1
ALOEINACTIVE INGREDIENTV5VD430YW9ITCH-X (PRAMOXINE HCL/BENZYL ALCOHOL) SPRAY [BF ASCHER AND CO INC]1
WATERINACTIVE INGREDIENT059QF0KO0RITCH-X (PRAMOXINE HCL/BENZYL ALCOHOL) SPRAY [BF ASCHER AND CO INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0225-0516ITCH-X (PRAMOXINE HCL/BENZYL ALCOHOL) SPRAY [BF ASCHER AND CO INC]3Legacy NDC20221103_03f85dbb-a13a-3126-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0225-0516-510022505165159.1 mL in 1 BOTTLE, SPRAY (0225-0516-51) 59.1 ml2014-09-190000-00-00NoNoCurrent