FDA.reportPublic FDA data

benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray

RxCUI
1049123
RxNorm name
benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray
Display name
Benzalkonium/Pramoxine (Topical)
Full name
benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray
Term type
SCD
Status
Active
Strength
0.13-1%
Dose form
Spray
Route
Topical
Updated
2026-07-30 22:46:44

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012011
Active start
012011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
benzalkonium chloride1.3 MG / 1 MLbenzalkoniumbenzalkonium chloride
pramoxine hydrochloride10 MG / 1 MLpramoxinepramoxine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Spray346165

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
benzalkonium1378
pramoxine34347

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRbenzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SprayNAMES
RxNorm Namebenzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SprayNAMES
RxNorm Synonymbenzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SprayNAMES
TTYSCDATTRIBUTES
SPL_SET_IDc2a8b134-8bb3-4e00-9df4-3229cb372da0CODES
SPL_SET_IDd55e6b09-0587-61a9-e053-2995a90afaf5CODES
SPL_SET_IDd5749cba-32f3-cf9c-e053-2a95a90a4416CODES
RxCUI1049123CODES
MMSL_CODEBD24544CODES
MMSL_CODECD24544CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
52651-055-0352651-055T.N. Dickinsons Wound Cleansing benzalkonium chloride, pramoxine hydrochlorideDickinson Brands Inc.M003
69968-0727-169968-0727Band Aid Antiseptic Cleansing To Go Benzalkonium Chloride, Pramoxine HClKenvue Brands LLCM017
69968-0729-869968-0729Band Aid Antiseptic Cleansing Benzalkonium Chloride, Pramoxine HClKenvue Brands LLCM017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M00352651-055T.N. Dickinsons Wound Cleansing benzalkonium chloride, pramoxine hydrochlorideOTC MONOGRAPH DRUGDickinson Brands Inc.
M01769968-0727Band Aid Antiseptic Cleansing To Go Benzalkonium Chloride, Pramoxine HClOTC MONOGRAPH DRUGKenvue Brands LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
52651005503rxnav_ndcsyes
58232007111rxnav_ndcsyes
68016010300rxnav_ndcsyes
69968072701rxnav_ndcsyes
69968072908rxnav_ndcsyes
05823207111rxnav_historical_indirect
08137202025rxnav_historical
12547023722rxnav_historical
12547023756rxnav_historical
12547040743rxnav_historical_indirect
48871000000rxnav_historical
58232071101rxnav_historical_indirect
58232400901rxnav_historical_indirect
69968005301rxnav_historical
82199061026rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
d55e6b09-0587-61a9-e053-2995a90afaf5benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD4Band Aid Antiseptic Cleansing20250605
d55e6b09-0587-61a9-e053-2995a90afaf5benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SprayPSN4Band Aid Antiseptic Cleansing20250605
d55e6b09-0587-61a9-e053-2995a90afaf5benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SpraySY4Band Aid Antiseptic Cleansing20250605
d5749cba-32f3-cf9c-e053-2a95a90a4416benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SpraySY3Band Aid Antiseptic Cleansing To Go20241106
d5749cba-32f3-cf9c-e053-2a95a90a4416benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SprayPSN3Band Aid Antiseptic Cleansing To Go20241106
d5749cba-32f3-cf9c-e053-2a95a90a4416benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD3Band Aid Antiseptic Cleansing To Go20241106
c2a8b134-8bb3-4e00-9df4-3229cb372da0benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SpraySY2T.N. Dickinson's ® Wound Cleansing20251201
c2a8b134-8bb3-4e00-9df4-3229cb372da0benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SprayPSN2T.N. Dickinson's ® Wound Cleansing20251201
c2a8b134-8bb3-4e00-9df4-3229cb372da0benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD2T.N. Dickinson's ® Wound Cleansing20251201
d11f5df7-b239-a407-e053-2995a90a728bbenzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SprayPSN120211119
d11f5df7-b239-a407-e053-2995a90a728bbenzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SpraySY120211119
d11f5df7-b239-a407-e053-2995a90a728bbenzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD120211119
60cc1ea1-f063-4988-bfe9-d18cfe323d92benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD1Drug Facts20100126
60cc1ea1-f063-4988-bfe9-d18cfe323d92benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SprayPSN1Drug Facts20100126
60cc1ea1-f063-4988-bfe9-d18cfe323d92benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SpraySY1Drug Facts20100126

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
c2a8b134-8bb3-4e00-9df4-3229cb372da0T.N. Dickinson's ® Wound CleansingDickinson Brands Inc. | American Distilling Inc.20251201
d55e6b09-0587-61a9-e053-2995a90afaf5Band Aid Antiseptic CleansingKenvue Brands LLC20250605
d5749cba-32f3-cf9c-e053-2a95a90a4416Band Aid Antiseptic Cleansing To GoKenvue Brands LLC20241106
d11f5df7-b239-a407-e053-2995a90a728bShandong Ruian Pharmaceutical Co.,Ltd.20211119
60cc1ea1-f063-4988-bfe9-d18cfe323d92Drug FactsHealth-Tech, Inc.20100126

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD04ABAnesthetics for topical useATC1-4pramoxine
ATCR02AAAntisepticsATC1-4benzalkonium
ATCC05ADLocal anestheticsATC1-4pramoxine
ATCD09AAMedicated dressings with antiinfectivesATC1-4benzalkonium
ATCD08AJQuaternary ammonium compoundsATC1-4benzalkonium
MEDRTD001548Benzalkonium CompoundsCHEMhas_ingredientbenzalkonium
MEDRTD001548Benzalkonium CompoundsCHEMhas_ingredientbenzalkonium chloride
MEDRTD009025MorpholinesCHEMhas_ingredientpramoxine
MEDRTD009025MorpholinesCHEMhas_ingredientpramoxine hydrochloride
MEDRTD001424Bacterial InfectionsDISEASEmay_preventbenzalkonium chloride
MEDRTD001424Bacterial InfectionsDISEASEmay_preventbenzalkonium
MEDRTD003877Dermatitis, ContactDISEASEmay_treatpramoxine
MEDRTD003877Dermatitis, ContactDISEASEmay_treatpramoxine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withpramoxine
MEDRTD004342Drug HypersensitivityDISEASEci_withbenzalkonium chloride
MEDRTD004342Drug HypersensitivityDISEASEci_withpramoxine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withbenzalkonium
MEDRTD005401Fissure in AnoDISEASEmay_treatpramoxine
MEDRTD005401Fissure in AnoDISEASEmay_treatpramoxine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatpramoxine
MEDRTD006484HemorrhoidsDISEASEmay_treatpramoxine hydrochloride
MEDRTD010146PainDISEASEmay_treatpramoxine
MEDRTD010146PainDISEASEmay_treatpramoxine hydrochloride
MEDRTD011537PruritusDISEASEmay_treatpramoxine
MEDRTD011537PruritusDISEASEmay_treatpramoxine hydrochloride
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moapramoxine hydrochloride
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moapramoxine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pepramoxine hydrochloride
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pepramoxine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH1.3 MG/ML / 10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD24544
CODESMMSL_CODECD24544
CODESRxCUI1049123
CODESSPL_SET_IDc2a8b134-8bb3-4e00-9df4-3229cb372da0
CODESSPL_SET_IDd55e6b09-0587-61a9-e053-2995a90afaf5
CODESSPL_SET_IDd5749cba-32f3-cf9c-e053-2a95a90a4416
NAMESPrescribable Synonymbenzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray
NAMESRXNAV_STRbenzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray
NAMESRxNorm Namebenzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray
NAMESRxNorm Synonymbenzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon