BERKLEY JENSEN

Product NDC
68391-150
11-digit product format
683910150
Labeler code
68391
Product ID
68391-150_fc6359ec-d9c4-4111-9234-9e1c26497ca2
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
BJWC
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-12-09
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68391-150IInactivated by FDA2026-10-05
excluded packagepackage68391-15068391-150-64IInactivated 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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68391-150-64d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68391-150-64f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68391-150-642ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68391-150-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68391-150-64cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68391-150-64cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68391-150-64302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68391-150-64ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68391-150-640efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68391-150-64ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68391-150-64367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68391-150-64557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68391-150-648af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68391-150-64834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68391-150-641332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68391-150-64fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68391-150-6486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68391-150-64bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68391-150-648dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68391-150-64e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68391-150-649bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68391-150-642020-01-31C16284748780-19d75b9d0-e9d1-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-150-64BERKLEY JENSENANTIBACTERIAL HAND1890 mL in 1 BOTTLE, PLASTICLIQUID18901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7BERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0BERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFABERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4BERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
POLOXAMER 124INACTIVE INGREDIENT1S66E28KXABERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)INACTIVE INGREDIENT0L414VCS5YBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1
WATERINACTIVE INGREDIENT059QF0KO0RBERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-150BERKLEY JENSEN ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1Legacy NDC, 1 package rows20141210_89a7f338-c7a3-4c33-a2db-586e0c596f83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN89a7f338-c7a3-4c33-a2db-586e0c596f831
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD89a7f338-c7a3-4c33-a2db-586e0c596f831
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY89a7f338-c7a3-4c33-a2db-586e0c596f831
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY89a7f338-c7a3-4c33-a2db-586e0c596f831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68391-150-64683910150641890 mL in 1 BOTTLE, PLASTIC1890 mlHistorical