HOME FORMATION ANTIBACTERIAL SHEA BUTTER

Product NDC
68121-005
Requested package NDC
68121-005-01
11-digit product format
681210005
Labeler code
68121
Product ID
68121-005_bafd9bbb-06ef-c450-e053-2a95a90a972e
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
PATCOS COSMETICS (INDIA) PRIVATE LIMITED
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-02-03
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/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 packagepackage68121-00568121-005-01IInactivated by FDA2026-09-14

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, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68121-005-012024-01-30C16284748780-11030e365-2e4d-111a-e063-dadaa90a10e26bfef619-5dff-488e-b3c8-1c982fdced39

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68121-005-01HOME FORMATION ANTIBACTERIAL SHEA BUTTER333 mL in 1 BOTTLELIQUID3332

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68121-005HOME FORMATION ANTIBACTERIAL SHEA BUTTER (BENZALKONIUM CHLORIDE) LIQUID [PATCOS COSMETICS (INDIA) PRIVATE LIMITED]2Legacy NDC, 1 package rows20210211_6bfef619-5dff-488e-b3c8-1c982fdced39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN6bfef619-5dff-488e-b3c8-1c982fdced392
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD6bfef619-5dff-488e-b3c8-1c982fdced392
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY6bfef619-5dff-488e-b3c8-1c982fdced392
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY6bfef619-5dff-488e-b3c8-1c982fdced392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68121-005-0168121000501333 mL in 1 BOTTLE (68121-005-01) 333 ml2021-02-030000-00-00NoNoCurrent