TOPCARE

Product NDC
36800-109
11-digit product format
368000109
Labeler code
36800
Product ID
36800-109_ce725323-49ca-4791-bb24-a31c375dc61b
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
TOPCO ASSOCIATES LLC
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-07-28
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-109IInactivated by FDA2026-10-15
excluded productproduct36800-109IInactivated by FDA2026-10-15
excluded productproduct36800-109IInactivated by FDA2026-10-15
excluded packagepackage36800-10936800-109-07IInactivated by FDA2026-10-15
excluded packagepackage36800-10936800-109-33IInactivated by FDA2026-10-15
excluded packagepackage36800-10936800-109-32IInactivated by FDA2026-10-15
excluded packagepackage36800-10936800-109-08IInactivated by FDA2026-10-15

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 3 · 147 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage36800-109-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage36800-109-33d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage36800-109-32d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage36800-109-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-109-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-109-33f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-109-32f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-109-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-109-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-109-332ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-109-322ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-109-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-109-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-109-33a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-109-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-109-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-109-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-109-33cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-109-32cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-109-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-109-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-109-33cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-109-32cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-109-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-109-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-109-33302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-109-32302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-109-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-109-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-109-33ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-109-32ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-109-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-109-070efc9e666f02…f202fb6c5f17…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-109-07TopCareAntibacterial Foaming Hand Fresh Pear222 mL in 1 BOTTLE, PLASTICLIQUID2221
36800-109-08TOPCAREANTIBACTERIAL FOAMING HAND FRESH PEAR222 mL in 1 BOTTLE, PLASTICLIQUID2221
36800-109-32TOPCAREANTIBACTERIAL FOAMING HAND FRESH PEAR946 mL in 1 BOTTLE, PLASTICLIQUID9461
36800-109-33TopCareAntibacterial Foaming Hand Fresh Pear946 mL in 1 BOTTLE, PLASTICLIQUID9461

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFATOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFATOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)INACTIVE INGREDIENT0L414VCS5YTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)INACTIVE INGREDIENT0L414VCS5YTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-109TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1Legacy NDC, 1 package rows20140730_100a9a87-334c-49e1-97de-8db81c1b3559.zip
36800-109TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1Legacy NDC, 1 package rows20140729_555e42f3-3638-4cff-ba22-22b197036339.zip
36800-109TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1Legacy NDC, 2 package rows20170502_b4a7e0b7-47d4-4ed0-a1c5-6c3e9dce3fa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN100a9a87-334c-49e1-97de-8db81c1b35591
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN555e42f3-3638-4cff-ba22-22b1970363391
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNb4a7e0b7-47d4-4ed0-a1c5-6c3e9dce3fa21
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD100a9a87-334c-49e1-97de-8db81c1b35591
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD555e42f3-3638-4cff-ba22-22b1970363391
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDb4a7e0b7-47d4-4ed0-a1c5-6c3e9dce3fa21
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY100a9a87-334c-49e1-97de-8db81c1b35591
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY555e42f3-3638-4cff-ba22-22b1970363391
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYb4a7e0b7-47d4-4ed0-a1c5-6c3e9dce3fa21
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY100a9a87-334c-49e1-97de-8db81c1b35591
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY555e42f3-3638-4cff-ba22-22b1970363391
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYb4a7e0b7-47d4-4ed0-a1c5-6c3e9dce3fa21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
36800-109-0736800010907222 mL in 1 BOTTLE, PLASTIC222 mlHistorical
36800-109-0836800010908222 mL in 1 BOTTLE, PLASTIC222 mlHistorical
36800-109-3236800010932946 mL in 1 BOTTLE, PLASTIC946 mlHistorical
36800-109-3336800010933946 mL in 1 BOTTLE, PLASTIC946 mlHistorical