FDA.reportPublic FDA data

PUROMA Hand Sanitizer Fragrance Free

Product NDC
80948-009
Requested package NDC
80948-009-13
11-digit product format
809480009
Labeler code
80948
Product ID
80948-009_d9649f0a-9498-6eca-e053-2995a90ae59b
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
ZENITH MICRO CONTROL
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-11
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage80948-00980948-009-13IInactivated 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
80948-009-01beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-02beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-03beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-04beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-05beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-06beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-07beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-08beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-09beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-10beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-11beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-12beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-13beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-14beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-15beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-16beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-17beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-18beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-19beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-20beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-21beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-22beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-23beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-24beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-25beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-26beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-27beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-28beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-29beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-30beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-31beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-32beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-33beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-34beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-35beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-36beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-37beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-38beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-39beb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-40beb3ff90-f8de-00d1-e053-2a95a90a6fdb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-009-01PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-01PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-009-02PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-009-02PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-03PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-03PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-009-04PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-009-04PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-05PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-009-05PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-06PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-009-06PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-07PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-009-07PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-08PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-009-08PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-09PUROMA Hand Sanitizer Fragrance Free89 mL in 1 BOTTLELIQUID893
80948-009-09PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-009-10PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-10PUROMA Hand Sanitizer Fragrance Free89 mL in 1 BOTTLELIQUID893
80948-009-11PUROMA Hand Sanitizer Fragrance Free89 mL in 1 BOTTLELIQUID893
80948-009-11PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-12PUROMA Hand Sanitizer Fragrance Free89 mL in 1 BOTTLELIQUID893
80948-009-12PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-13PUROMA Hand Sanitizer Fragrance Free89 mL in 1 BOTTLELIQUID893
80948-009-13PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-14PUROMA Hand Sanitizer Fragrance Free178 mL in 1 BOTTLELIQUID1783
80948-009-14PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-009-15PUROMA Hand Sanitizer Fragrance Free178 mL in 1 BOTTLELIQUID1783
80948-009-15PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-16PUROMA Hand Sanitizer Fragrance Free178 mL in 1 BOTTLELIQUID1783
80948-009-16PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-17PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-17PUROMA Hand Sanitizer Fragrance Free178 mL in 1 BOTTLELIQUID1783
80948-009-18PUROMA Hand Sanitizer Fragrance Free178 mL in 1 BOTTLELIQUID1783
80948-009-18PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-19PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-009-19PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-20PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-20PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-21PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-21PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-22PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-22PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-23PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-23PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-24PUROMA Hand Sanitizer Fragrance Free2 in 1 PACKAGELIQUID23
80948-009-24PUROMA Hand Sanitizer Fragrance Free326 mL in 1 BOTTLELIQUID3263
80948-009-25PUROMA Hand Sanitizer Fragrance Free326 mL in 1 BOTTLELIQUID3263
80948-009-25PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-009-26PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-26PUROMA Hand Sanitizer Fragrance Free326 mL in 1 BOTTLELIQUID3263
80948-009-27PUROMA Hand Sanitizer Fragrance Free488 mL in 1 BOTTLELIQUID4883
80948-009-27PUROMA Hand Sanitizer Fragrance Free2 in 1 PACKAGELIQUID23
80948-009-28PUROMA Hand Sanitizer Fragrance Free947 mL in 1 BOTTLELIQUID9473
80948-009-28PUROMA Hand Sanitizer Fragrance Free2 in 1 PACKAGELIQUID23
80948-009-29PUROMA Hand Sanitizer Fragrance Free5000 mL in 1 CANLIQUID50003
80948-009-30PUROMA Hand Sanitizer Fragrance Free50000 mL in 1 CANLIQUID500003
80948-009-31PUROMA Hand Sanitizer Fragrance Free200000 mL in 1 DRUMLIQUID2000003
80948-009-32PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-009-32PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-33PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-009-33PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-34PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-009-34PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-35PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-009-35PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-36PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-009-37PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-009-38PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-39PUROMA Hand Sanitizer Fragrance Free488 mL in 1 BOTTLELIQUID4883
80948-009-40PUROMA Hand Sanitizer Fragrance Free947 mL in 1 BOTTLELIQUID9473

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-009PUROMA HAND SANITIZER FRAGRANCE FREE (ALCOHOL) LIQUID [ZENITH MICRO CONTROL]3Legacy NDC, 72 package rows20231215_beb3ff90-f8de-00d1-e053-2a95a90a6fdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSNbeb3ff90-f8de-00d1-e053-2a95a90a6fdb3
582753ethanol 0.7 ML/ML Topical SolutionSCDbeb3ff90-f8de-00d1-e053-2a95a90a6fdb3
582753ethanol 70 % Topical SolutionSYbeb3ff90-f8de-00d1-e053-2a95a90a6fdb3
582753ethyl alcohol 70 % Topical SolutionSYbeb3ff90-f8de-00d1-e053-2a95a90a6fdb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-009-138094800091348 BOTTLE in 1 PACKAGE (80948-009-13) > 89 mL in 1 BOTTLE48 bottle2021-03-110000-00-00NoNoCurrent