FDA.reportPublic FDA data

First Aid Antiseptic

Product NDC
69103-3501
11-digit product format
691033501
Labeler code
69103
Product ID
69103-3501_ed3cb7fd-75d1-4b20-ad45-39fd5763a751
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride and benzocaine
Dosage form
SPRAY
Route
TOPICAL
Labeler
Provision Medical
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-08-29
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength
1 g/L; g/L
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69103-3501IInactivated by FDA2026-07-31
excluded packagepackage69103-350169103-3501-1IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MistALCOHOLDerma Glove4513f6b9-ceac-415d-a1af-1f7585c5989e2025-11-14WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove90058ba8-e55d-4318-9fc5-8f0d25dfdd992025-11-14WarningsExact identifier
KONIX Alcohol Antiseptic Hand RubKONIX ALCOHOL ANTISEPTIC HAND RUBTURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS17435b35-815b-4292-a809-e533ea137b802025-01-29WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove074a760f-9031-40c1-9867-95ef0345418d2025-01-08WarningsExact identifier
MistALCOHOLDerma Glove2a0bcc4e-5114-4afc-91cb-cb4816a63db22024-10-09WarningsExact identifier
HandLOTIONDerma Gloveba9611a3-e2a4-4835-9ffe-aafe85a7cb9c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove45d130c9-0835-45bb-b525-86a2119c87d12024-10-09WarningsExact identifier
MistALCOHOLDerma Gloveb5bfd7f0-0f96-459e-84d4-24b2081ae46f2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glovee2f89d56-5624-4a94-8151-1edb508232ac2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove06f74478-57aa-4b8d-b888-55e1ee4fbd452024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloved3926f48-3a42-42df-a850-47b3914ba3b62024-10-09WarningsExact identifier
MistALCOHOLDerma Glove7c21ee1c-ce2a-464b-8269-cdb3e59db0942024-10-09WarningsExact identifier
HandLOTIONDerma Glovebcd71f37-63aa-4ad9-a9be-e5519c7e66e72024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloveffdfb167-0efa-4cd8-afdf-e1ff69ee62522024-10-09WarningsExact identifier
MistALCOHOLDerma Glove11c2939c-e77a-48f6-949c-9d508714012b2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glovee6cfe092-cb2c-441b-8897-98626c43bef82024-10-09WarningsExact identifier
HandLOTIONDerma Glove642cc56f-9f39-46be-bbd8-a2346a0efac42024-10-09WarningsExact identifier
HandLOTIONDerma Glove93736944-7535-4035-93aa-4771138af8e32024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove39867f66-b641-4060-881d-161c2591d19c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove767cc1f2-89a2-4d0b-ae49-ad7b9afca18b2024-10-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Flammable. Keep away from children.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69103-3501-12020-01-31C16284748780-19d75b9d1-2256-f424-e053-dadaa90a57ce527232df-20d6-4e10-a478-e42a7a6dc20f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69103-3501-1First Aid Antiseptic0.0591 L in 1 BOTTLE, SPRAYSPRAY0.05911

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W7FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY [PROVISION MEDICAL]1
benzocaineACTIVE INGREDIENTU3RSY48JW5FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY [PROVISION MEDICAL]1
benzalkoniumACTIVE MOIETY7N6JUD5X6YFIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY [PROVISION MEDICAL]1
benzocaineACTIVE MOIETYU3RSY48JW5FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY [PROVISION MEDICAL]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY [PROVISION MEDICAL]1
waterINACTIVE INGREDIENT059QF0KO0RFIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY [PROVISION MEDICAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69103-3501FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY [PROVISION MEDICAL]1Legacy NDC, 1 package rows20140904_527232df-20d6-4e10-a478-e42a7a6dc20f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245229benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN527232df-20d6-4e10-a478-e42a7a6dc20f1
1245229benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD527232df-20d6-4e10-a478-e42a7a6dc20f1
1245229benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY527232df-20d6-4e10-a478-e42a7a6dc20f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69103-3501-1691033501010.0591 L in 1 BOTTLE, SPRAY0.0591 lHistorical