FDA.reportPublic FDA data

PUROMA Antibacterial Hand Wash Fragrance Free

Product NDC
80948-006
Requested package NDC
80948-006-08
11-digit product format
809480006
Labeler code
80948
Product ID
80948-006_d1788db5-83cc-9ba9-e053-2a95a90a3de6
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
ZENITH MICRO CONTROL
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-05
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
130 mg/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 packagepackage80948-00680948-006-08IInactivated 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 · 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
80948-006-0135f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-0235f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-0335f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-0435f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-0535f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-0635f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-0735f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-0835f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-0935f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-1035f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-1135f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-1235f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-1335f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-1435f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-1535f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-1635f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-1735f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-1835f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-1935f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-2035f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-2135f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-2235f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-2335f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-2435f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-2535f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-2635f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-2735f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-2835f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-2935f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-3035f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-3135f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-3235f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-3335f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-3435f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-3535f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-3635f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-3735f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-3835f2dec6-2f9b-408b-84c2-06c76eae2d3b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-006-01PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 PACKAGELIQUID1784
80948-006-01PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-02PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 PACKAGELIQUID1784
80948-006-02PUROMA Antibacterial Hand Wash Fragrance Free6 in 1 PACKAGELIQUID64
80948-006-03PUROMA Antibacterial Hand Wash Fragrance Free8 in 1 PACKAGELIQUID84
80948-006-03PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 PACKAGELIQUID1784
80948-006-04PUROMA Antibacterial Hand Wash Fragrance Free12 in 1 PACKAGELIQUID124
80948-006-04PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 PACKAGELIQUID1784
80948-006-05PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 PACKAGELIQUID1784
80948-006-05PUROMA Antibacterial Hand Wash Fragrance Free24 in 1 PACKAGELIQUID244
80948-006-06PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-06PUROMA Antibacterial Hand Wash Fragrance Free2 in 1 PACKAGELIQUID24
80948-006-07PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-07PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-08PUROMA Antibacterial Hand Wash Fragrance Free6 in 1 PACKAGELIQUID64
80948-006-08PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-09PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-09PUROMA Antibacterial Hand Wash Fragrance Free8 in 1 PACKAGELIQUID84
80948-006-10PUROMA Antibacterial Hand Wash Fragrance Free12 in 1 PACKAGELIQUID124
80948-006-10PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-11PUROMA Antibacterial Hand Wash Fragrance Free24 in 1 PACKAGELIQUID244
80948-006-11PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-12PUROMA Antibacterial Hand Wash Fragrance Free2 in 1 PACKAGELIQUID24
80948-006-12PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-13PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-13PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-14PUROMA Antibacterial Hand Wash Fragrance Free6 in 1 PACKAGELIQUID64
80948-006-14PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-15PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-15PUROMA Antibacterial Hand Wash Fragrance Free8 in 1 PACKAGELIQUID84
80948-006-16PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-16PUROMA Antibacterial Hand Wash Fragrance Free12 in 1 PACKAGELIQUID124
80948-006-17PUROMA Antibacterial Hand Wash Fragrance Free24 in 1 PACKAGELIQUID244
80948-006-17PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-18PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-18PUROMA Antibacterial Hand Wash Fragrance Free2 in 1 PACKAGELIQUID24
80948-006-19PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-19PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-20PUROMA Antibacterial Hand Wash Fragrance Free6 in 1 PACKAGELIQUID64
80948-006-20PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-21PUROMA Antibacterial Hand Wash Fragrance Free8 in 1 PACKAGELIQUID84
80948-006-21PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-22PUROMA Antibacterial Hand Wash Fragrance Free12 in 1 PACKAGELIQUID124
80948-006-22PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-23PUROMA Antibacterial Hand Wash Fragrance Free24 in 1 PACKAGELIQUID244
80948-006-23PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-24PUROMA Antibacterial Hand Wash Fragrance Free947 mL in 1 BOTTLELIQUID9474
80948-006-24PUROMA Antibacterial Hand Wash Fragrance Free2 in 1 PACKAGELIQUID24
80948-006-25PUROMA Antibacterial Hand Wash Fragrance Free947 mL in 1 BOTTLELIQUID9474
80948-006-25PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-26PUROMA Antibacterial Hand Wash Fragrance Free5000 mL in 1 CANLIQUID50004
80948-006-27PUROMA Antibacterial Hand Wash Fragrance Free50000 mL in 1 CANLIQUID500004
80948-006-28PUROMA Antibacterial Hand Wash Fragrance Free200000 mL in 1 DRUMLIQUID2000004
80948-006-29PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-29PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-30PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-30PUROMA Antibacterial Hand Wash Fragrance Free6 in 1 PACKAGELIQUID64
80948-006-31PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-31PUROMA Antibacterial Hand Wash Fragrance Free8 in 1 PACKAGELIQUID84
80948-006-32PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-32PUROMA Antibacterial Hand Wash Fragrance Free12 in 1 PACKAGELIQUID124
80948-006-33PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-33PUROMA Antibacterial Hand Wash Fragrance Free24 in 1 PACKAGELIQUID244
80948-006-34PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-35PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-36PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-37PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-38PUROMA Antibacterial Hand Wash Fragrance Free974 mL in 1 BOTTLELIQUID9744

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-006PUROMA ANTIBACTERIAL HAND WASH FRAGRANCE FREE (BENZALKONIUM CHLORIDE) LIQUID [ZENITH MICRO CONTROL]4Legacy NDC, 68 package rows20231215_35f2dec6-2f9b-408b-84c2-06c76eae2d3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN35f2dec6-2f9b-408b-84c2-06c76eae2d3b4
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD35f2dec6-2f9b-408b-84c2-06c76eae2d3b4
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY35f2dec6-2f9b-408b-84c2-06c76eae2d3b4
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY35f2dec6-2f9b-408b-84c2-06c76eae2d3b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-006-08809480006086 BOTTLE in 1 PACKAGE (80948-006-08) > 237 mL in 1 BOTTLE6 bottle2021-03-090000-00-00NoNoCurrent