Mi

Product NDC
81563-013
Requested package NDC
81563-013-16
11-digit product format
815630013
Labeler code
81563
Product ID
81563-013_b689bda7-cadf-0564-e053-2995a90a4f8a
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride HS
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Infinity Manufacturing of America, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-02-23
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/mL
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 packagepackage81563-01381563-013-16IInactivated by FDA2026-08-11

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81563-013-00Mi3785 mL in 1 BOTTLE, PUMPSOLUTION37851
81563-013-08Mi236 mL in 1 BOTTLE, PUMPSOLUTION2361
81563-013-16Mi473 mL in 1 BOTTLE, PUMPSOLUTION4731
81563-013-32Mi946 mL in 1 BOTTLE, PUMPSOLUTION9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81563-013MI (BENZALKONIUM CHLORIDE HS) SOLUTION [INFINITY MANUFACTURING OF AMERICA, LLC]1Legacy NDC, 4 package rows20210424_b689bda7-cade-0564-e053-2995a90a4f8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNb689bda7-cade-0564-e053-2995a90a4f8a1
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDb689bda7-cade-0564-e053-2995a90a4f8a1
1049254benzalkonium chloride 0.13 % Topical SolutionSYb689bda7-cade-0564-e053-2995a90a4f8a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81563-013-1681563001316473 mL in 1 BOTTLE, PUMP (81563-013-16) 473 ml2021-02-230000-00-00NoNoCurrent