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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRbenzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray1NAMES
RxNorm Namebenzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray1NAMES
RxNorm Synonymbenzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI10491231CODES
MMSL_CODE
2 linked values
2CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 15 matching rows.

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

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
T.N. Dickinsons Wound CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDEDickinson Brands Inc.c2a8b134-8bb3-4e00-9df4-3229cb372da02025-12-01WarningsExact identifier
ndc (package): 52651-055-03
ndc (product): 52651-055
ndc11 (package): 52651005503
rxcui: 1049123
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd55e6b09-0587-61a9-e053-2995a90afaf52025-06-05WarningsExact identifier
ndc (package): 69968-0729-8
ndc (product): 69968-0729
ndc11 (package): 69968072908
rxcui: 1049123
Band Aid Antiseptic Cleansing To GoBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd5749cba-32f3-cf9c-e053-2a95a90a44162024-11-06WarningsExact identifier
ndc (package): 69968-0727-1
ndc (product): 69968-0727
ndc11 (package): 69968072701
rxcui: 1049123

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d55e6b09-0587-61a9-e053-2995a90afaf5benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray [PSN] · benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray [SCD] · benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray [SY]34Band Aid Antiseptic Cleansing20250605
d5749cba-32f3-cf9c-e053-2a95a90a4416benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray [PSN] · benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray [SCD] · benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray [SY]33Band Aid Antiseptic Cleansing To Go20241106
c2a8b134-8bb3-4e00-9df4-3229cb372da0benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray [PSN] · benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray [SCD] · benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray [SY]32T.N. Dickinson's ® Wound Cleansing20251201
d11f5df7-b239-a407-e053-2995a90a728bbenzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray [PSN] · benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray [SCD] · benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray [SY]3120211119
60cc1ea1-f063-4988-bfe9-d18cfe323d92benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray [PSN] · benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray [SCD] · benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray [SY]31Drug Facts20100126

Recently Linked 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
7b315b7d-90e4-4bc2-9230-44dd2d1ae70bNEOSPORIN ® + PAIN RELIEF NEO TO GO! ® FIRST AID ANTISEPTIC/PAIN RELIEVING SPRAYJohnson & Johnson Consumer Inc.20230713
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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymbenzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon