MEDI-FIRST First Aid Antiseptic

Product NDC
78495-122
11-digit product format
784950122
Labeler code
78495
Product ID
78495-122_3239abbd-8033-7f52-e063-6294a90a8740
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Ultra Distributors Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-19
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78495-122-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78495-122-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78495-122-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage78495-122-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage78495-122-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage78495-122-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage78495-122-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
MEDI-FIRST First Aid Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039012Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6efaca5-49d0-b000-e053-2995a90ab9aaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78495-122-012025-04-07C16284748780-12cef2736-a700-d83d-e063-dadaa90ab31f78495-122
78495-122-012025-01-30C16284748780-12cef2736-a700-d83d-e063-dadaa90ab31f78495-122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78495-122-01MEDI-FIRST First Aid Antiseptic59.1 mL in 1 BOTTLE, PUMPSPRAY59.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78495-122MEDI-FIRST FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE) SPRAY [ULTRA DISTRIBUTORS INC]2Current NDC, Legacy NDC, 1 package rows20250409_b6efaca5-49d0-b000-e053-2995a90ab9aa.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 18 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntifungalMICONAZOLE NITRATEAdvantice Health, LLC9a47fb1b-a41f-4c8a-8e43-7332853c308e2026-03-19WarningsExact identifier
application number: M005
AntifungalCLOTRIMAZOLEDynarex Corporation4d4cc4b4-c0b4-9e25-e063-6294a90a70b82026-03-18WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEDynarex Corporation4d384385-f3c5-09ba-e063-6394a90aec7f2026-03-17WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriese21ccb83-54ff-4605-80bf-7b4b789c7cb72026-03-17WarningsExact identifier
application number: M005
Peunitory Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.4d2e86bc-5122-ba4a-e063-6394a90acf132026-03-16WarningsExact identifier
application number: M005
DRMITSUI FOOT ANTIFUNGAL TREATMENTSALICYLIC ACIDZhenping Renren Industry Co., Ltd.4ce59d31-56fe-d74f-e063-6294a90a7cce2026-03-14WarningsExact identifier
application number: M005
NERANTE FUNGUS NAIL PENUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3984b-53cd-a665-e063-6394a90afe5f2026-03-13WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENTUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3f0e2-b532-b89f-e063-6294a90a7e252026-03-13WarningsExact identifier
application number: M005
BYT BANGYTONG HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShenzhen Jindali Technology Co., Ltd49ed1cc8-e8e5-399c-e063-6394a90a044a2026-03-10WarningsExact identifier
application number: M005
Natouch Antifungal Wipes PlusANTIFUNGAL ANTISEPTIC WIPES PLUSNatouch LLCa85cb307-b3ad-1584-e053-2995a90a9a702026-03-10WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb6fdfd-116e-14e9-e063-6294a90a4de32026-03-10WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb73ebe-f9bb-5a8d-e063-6294a90a3c2b2026-03-10WarningsExact identifier
application number: M005
SootheSense Toenail Fungus TreatmentUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ca2bbeb-3b8a-9482-e063-6294a90a57892026-03-09WarningsExact identifier
application number: M005
Natouch Antifungal Antiseptic WipesANTIFUNGAL ANTISEPTIC WIPESNatouch LLC4c84c556-8d0b-ec28-e063-6294a90af1d32026-03-08WarningsExact identifier
application number: M005
ANTIFUNGAL CreamANGELICA DAHURICA EXTRACTT, ASIATIC ACIDGuangzhou Mizi Biotechnology Co., LTD.4c586cd9-d356-34d8-e063-6294a90a4d112026-03-06WarningsExact identifier
application number: M005
FungiFoamTOLNAFTATEThe Tetra Corporation2449e8e5-9d7e-4119-9e7a-378efe55f8752026-03-06WarningsExact identifier
application number: M005
RoyceDerm ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4c43e62b-9060-8962-e063-6394a90aff632026-03-05WarningsExact identifier
application number: M005
Derman AntifungalTOLNAFTATECompania Internacional de Comercio, S.A.P.I. de C.V.5784a783-1056-4d50-8d87-2df4f8e16b092026-03-05WarningsExact identifier
application number: M005
Antifungal PowderTOLNAFTATEARMY & AIR FORCE EXCHANGE SERVICE4c39e121-4919-a482-e063-6294a90a98cd2026-03-04WarningsExact identifier
application number: M005
ViLLsure Antifungal PenUNDECYLENIC ACID 25%ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD4c28cf04-94ad-8db6-e063-6394a90a2eed2026-03-03WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSNb6efaca5-49d0-b000-e053-2995a90ab9aa2
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCDb6efaca5-49d0-b000-e053-2995a90ab9aa2
1039012benzalkonium chloride 0.13 % Topical SpraySYb6efaca5-49d0-b000-e053-2995a90ab9aa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78495-122-017849501220159.1 mL in 1 BOTTLE, PUMP (78495-122-01) 59.1 ml2020-12-190000-00-00NoNoCurrent