FDA.reportPublic FDA data

PUROMA Antibacterial Hand Wash with Fragrance Lavender rose

Product NDC
80948-015
Requested package NDC
80948-015-04
11-digit product format
809480015
Labeler code
80948
Product ID
80948-015_d1785b31-cee9-68c9-e053-2a95a90a85c0
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 packagepackage80948-01580948-015-04DDiscontinued by firm2026-10-12

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 · 12 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…

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
80948-015-0187dfce36-498c-4def-bae7-8f28d8739e60
80948-015-0287dfce36-498c-4def-bae7-8f28d8739e60
80948-015-0387dfce36-498c-4def-bae7-8f28d8739e60
80948-015-0487dfce36-498c-4def-bae7-8f28d8739e60
80948-015-0587dfce36-498c-4def-bae7-8f28d8739e60
80948-015-0687dfce36-498c-4def-bae7-8f28d8739e60
80948-015-0787dfce36-498c-4def-bae7-8f28d8739e60
80948-015-0887dfce36-498c-4def-bae7-8f28d8739e60
80948-015-0987dfce36-498c-4def-bae7-8f28d8739e60
80948-015-1087dfce36-498c-4def-bae7-8f28d8739e60
80948-015-1187dfce36-498c-4def-bae7-8f28d8739e60
80948-015-1287dfce36-498c-4def-bae7-8f28d8739e60
80948-015-1387dfce36-498c-4def-bae7-8f28d8739e60
80948-015-1487dfce36-498c-4def-bae7-8f28d8739e60
80948-015-1587dfce36-498c-4def-bae7-8f28d8739e60
80948-015-1687dfce36-498c-4def-bae7-8f28d8739e60
80948-015-1787dfce36-498c-4def-bae7-8f28d8739e60
80948-015-1887dfce36-498c-4def-bae7-8f28d8739e60
80948-015-1987dfce36-498c-4def-bae7-8f28d8739e60
80948-015-2087dfce36-498c-4def-bae7-8f28d8739e60
80948-015-2187dfce36-498c-4def-bae7-8f28d8739e60
80948-015-2287dfce36-498c-4def-bae7-8f28d8739e60
80948-015-2387dfce36-498c-4def-bae7-8f28d8739e60
80948-015-2487dfce36-498c-4def-bae7-8f28d8739e60
80948-015-2587dfce36-498c-4def-bae7-8f28d8739e60
80948-015-2687dfce36-498c-4def-bae7-8f28d8739e60
80948-015-2787dfce36-498c-4def-bae7-8f28d8739e60
80948-015-2887dfce36-498c-4def-bae7-8f28d8739e60
80948-015-2987dfce36-498c-4def-bae7-8f28d8739e60
80948-015-3087dfce36-498c-4def-bae7-8f28d8739e60
80948-015-3187dfce36-498c-4def-bae7-8f28d8739e60
80948-015-3287dfce36-498c-4def-bae7-8f28d8739e60
80948-015-3387dfce36-498c-4def-bae7-8f28d8739e60
80948-015-3487dfce36-498c-4def-bae7-8f28d8739e60

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-015-01PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-01PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 PACKAGELIQUID1783
80948-015-02PUROMA Antibacterial Hand Wash with Fragrance Lavender rose6 in 1 PACKAGELIQUID63
80948-015-02PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 PACKAGELIQUID1783
80948-015-03PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 PACKAGELIQUID1783
80948-015-03PUROMA Antibacterial Hand Wash with Fragrance Lavender rose8 in 1 PACKAGELIQUID83
80948-015-04PUROMA Antibacterial Hand Wash with Fragrance Lavender rose12 in 1 PACKAGELIQUID123
80948-015-04PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 PACKAGELIQUID1783
80948-015-05PUROMA Antibacterial Hand Wash with Fragrance Lavender rose24 in 1 PACKAGELIQUID243
80948-015-05PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 PACKAGELIQUID1783
80948-015-06PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-06PUROMA Antibacterial Hand Wash with Fragrance Lavender rose2 in 1 PACKAGELIQUID23
80948-015-07PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-07PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-08PUROMA Antibacterial Hand Wash with Fragrance Lavender rose6 in 1 PACKAGELIQUID63
80948-015-08PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-09PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-09PUROMA Antibacterial Hand Wash with Fragrance Lavender rose8 in 1 PACKAGELIQUID83
80948-015-10PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-10PUROMA Antibacterial Hand Wash with Fragrance Lavender rose12 in 1 PACKAGELIQUID123
80948-015-11PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-11PUROMA Antibacterial Hand Wash with Fragrance Lavender rose24 in 1 PACKAGELIQUID243
80948-015-12PUROMA Antibacterial Hand Wash with Fragrance Lavender rose2 in 1 PACKAGELIQUID23
80948-015-12PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-13PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-13PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-14PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-14PUROMA Antibacterial Hand Wash with Fragrance Lavender rose6 in 1 PACKAGELIQUID63
80948-015-15PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-15PUROMA Antibacterial Hand Wash with Fragrance Lavender rose8 in 1 PACKAGELIQUID83
80948-015-16PUROMA Antibacterial Hand Wash with Fragrance Lavender rose12 in 1 PACKAGELIQUID123
80948-015-16PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-17PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-17PUROMA Antibacterial Hand Wash with Fragrance Lavender rose24 in 1 PACKAGELIQUID243
80948-015-18PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-18PUROMA Antibacterial Hand Wash with Fragrance Lavender rose2 in 1 PACKAGELIQUID23
80948-015-19PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-19PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-20PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-20PUROMA Antibacterial Hand Wash with Fragrance Lavender rose6 in 1 PACKAGELIQUID63
80948-015-21PUROMA Antibacterial Hand Wash with Fragrance Lavender rose8 in 1 PACKAGELIQUID83
80948-015-21PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-22PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-22PUROMA Antibacterial Hand Wash with Fragrance Lavender rose12 in 1 PACKAGELIQUID123
80948-015-23PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-23PUROMA Antibacterial Hand Wash with Fragrance Lavender rose24 in 1 PACKAGELIQUID243
80948-015-24PUROMA Antibacterial Hand Wash with Fragrance Lavender rose947 mL in 1 BOTTLELIQUID9473
80948-015-24PUROMA Antibacterial Hand Wash with Fragrance Lavender rose2 in 1 PACKAGELIQUID23
80948-015-25PUROMA Antibacterial Hand Wash with Fragrance Lavender rose947 mL in 1 BOTTLELIQUID9473
80948-015-25PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-26PUROMA Antibacterial Hand Wash with Fragrance Lavender rose5000 mL in 1 CANLIQUID50003
80948-015-27PUROMA Antibacterial Hand Wash with Fragrance Lavender rose50000 mL in 1 CANLIQUID500003
80948-015-28PUROMA Antibacterial Hand Wash with Fragrance Lavender rose200000 mL in 1 DRUMLIQUID2000003
80948-015-29PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-30PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-31PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 BOTTLELIQUID1783
80948-015-31PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-32PUROMA Antibacterial Hand Wash with Fragrance Lavender rose6 in 1 PACKAGELIQUID63
80948-015-32PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 BOTTLELIQUID1783
80948-015-33PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 BOTTLELIQUID1783
80948-015-33PUROMA Antibacterial Hand Wash with Fragrance Lavender rose8 in 1 PACKAGELIQUID83
80948-015-34PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 BOTTLELIQUID1783
80948-015-34PUROMA Antibacterial Hand Wash with Fragrance Lavender rose12 in 1 PACKAGELIQUID123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-015PUROMA ANTIBACTERIAL HAND WASH WITH FRAGRANCE LAVENDER ROSE (BENZALKONIUM CHLORIDE) LIQUID [ZENITH MICRO CONTROL]3Legacy NDC, 63 package rows20231215_87dfce36-498c-4def-bae7-8f28d8739e60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN87dfce36-498c-4def-bae7-8f28d8739e603
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD87dfce36-498c-4def-bae7-8f28d8739e603
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY87dfce36-498c-4def-bae7-8f28d8739e603
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY87dfce36-498c-4def-bae7-8f28d8739e603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-015-048094800150412 PACKAGE in 1 PACKAGE (80948-015-04) > 178 mL in 1 PACKAGE12 package2021-04-240000-00-00NoNoCurrent