HOLY WATER MERCY IN A BOTTLE

Product NDC
59228-104
Requested package NDC
59228-104-18
11-digit product format
592280104
Labeler code
59228
Product ID
59228-104_dd46426d-7112-0d40-e053-2995a90a7e1a
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HCL, BENZALKONIUM CHLORIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
EMS Contract Packaging
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-04-25
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
0 g/1000mL; g/1000mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59228-104-182025-01-30C16284748780-12cef2736-af55-d83d-e063-dadaa90ab31fEMS (as CMO) - Holy Water (59228-104)

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59228-104HOLY WATER MERCY IN A BOTTLE (LIDOCAINE HCL, BENZALKONIUM CHLORIDE) SOLUTION [EMS CONTRACT PACKAGING]4Legacy NDC20220423_1933d0fa-c1b1-4390-bc79-b83c85871c49.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59228-104-1859228010418250 mL in 1 BOTTLE (59228-104-18) 250 ml2019-04-250000-00-00NoNoCurrent