FDA.reportPublic FDA data

Bonita Alcohol Sanitizing

Product NDC
78409-001
Requested package NDC
78409-001-14
11-digit product format
784090001
Labeler code
78409
Product ID
78409-001_d001cca6-5336-9d3c-e053-2995a90a17ac
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol Sanitizing Spray
Dosage form
SPRAY
Route
TOPICAL
Labeler
Moreno and Sons Company
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-20
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78409-00178409-001-14IInactivated by FDA2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
78409-001-01Bonita Alcohol Sanitizing Spray
78409-001-02Bonita Alcohol Sanitizing Spray
78409-001-03Bonita Alcohol Sanitizing Spray
78409-001-04Bonita Alcohol Sanitizing Spray
78409-001-05Bonita Alcohol Sanitizing Spray
78409-001-06Bonita Alcohol Sanitizing Spray
78409-001-07Bonita Alcohol Sanitizing Spray
78409-001-08Bonita Alcohol Sanitizing Spray
78409-001-09Bonita Alcohol Sanitizing Spray
78409-001-10Bonita Alcohol Sanitizing Spray
78409-001-11Bonita Alcohol Sanitizing Spray
78409-001-12Bonita Alcohol Sanitizing Spray
78409-001-13Bonita Alcohol Sanitizing Spray
78409-001-14Bonita Alcohol Sanitizing Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78409-001-01Bonita Alcohol Sanitizing60 mL in 1 BOTTLESPRAY603
78409-001-02Bonita Alcohol Sanitizing100 mL in 1 BOTTLESPRAY1003
78409-001-03Bonita Alcohol Sanitizing120 mL in 1 BOTTLESPRAY1203
78409-001-04Bonita Alcohol Sanitizing150 mL in 1 BOTTLESPRAY1503
78409-001-05Bonita Alcohol Sanitizing200 mL in 1 BOTTLESPRAY2003
78409-001-06Bonita Alcohol Sanitizing235 mL in 1 BOTTLESPRAY2353
78409-001-07Bonita Alcohol Sanitizing250 mL in 1 BOTTLESPRAY2503
78409-001-08Bonita Alcohol Sanitizing260 mL in 1 BOTTLESPRAY2603
78409-001-09Bonita Alcohol Sanitizing290 mL in 1 BOTTLESPRAY2903
78409-001-10Bonita Alcohol Sanitizing300 mL in 1 BOTTLESPRAY3003
78409-001-11Bonita Alcohol Sanitizing500 mL in 1 BOTTLESPRAY5003
78409-001-12Bonita Alcohol Sanitizing950 mL in 1 BOTTLESPRAY9503
78409-001-13Bonita Alcohol Sanitizing1000 mL in 1 BOTTLESPRAY10003
78409-001-14Bonita Alcohol Sanitizing2000 mL in 1 BOTTLESPRAY20003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78409-001BONITA ALCOHOL SANITIZING (ALCOHOL SANITIZING SPRAY) SPRAY [MORENO AND SONS COMPANY]3Legacy NDC, 14 package rows20211106_a695f0ba-f025-95d9-e053-2995a90a1d20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2286295ethanol 75 % Topical SprayPSNa695f0ba-f025-95d9-e053-2995a90a1d203
2286295ethanol 0.75 ML/ML Topical SpraySCDa695f0ba-f025-95d9-e053-2995a90a1d203
2286295ethanol 75 % Topical SpraySYa695f0ba-f025-95d9-e053-2995a90a1d203

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78409-001-14784090001142000 mL in 1 BOTTLE (78409-001-14) 2000 ml2020-04-200000-00-00NoNoCurrent