FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
78048-002
Requested package NDC
78048-002-15
11-digit product format
780480002
Labeler code
78048
Product ID
78048-002_a853e0a4-5c18-65e9-e053-2995a90a49dc
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Dongguan City Dexu Toys Co.,Ltd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-16
Marketing end
0000-00-00
Substance
ISOPROPYL ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage78048-00278048-002-15IInactivated 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 · 18 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDCIndexing SPLRelated label
78048-002-01d6a99b39-a7ea-a426-e053-dadaa90af4c2a72b4560-028f-7342-e053-2995a90a9901
78048-002-02d6a99b39-a7ea-a426-e053-dadaa90af4c2a72b4560-028f-7342-e053-2995a90a9901
78048-002-03d6a99b39-a7ea-a426-e053-dadaa90af4c2a72b4560-028f-7342-e053-2995a90a9901
78048-002-04d6a99b39-f474-a426-e053-dadaa90af4c2a72c5e02-3fac-446d-e053-2a95a90a0cda
78048-002-05d6a99b39-f474-a426-e053-dadaa90af4c2a72c5e02-3fac-446d-e053-2a95a90a0cda
78048-002-06d6a99b39-f474-a426-e053-dadaa90af4c2a72c5e02-3fac-446d-e053-2a95a90a0cda
78048-002-07d6a99b39-f533-a426-e053-dadaa90af4c2a8458718-7acb-82e9-e053-2995a90a4ef1
78048-002-08d6a99b39-f533-a426-e053-dadaa90af4c2a8458718-7acb-82e9-e053-2995a90a4ef1
78048-002-09d6a99b39-f533-a426-e053-dadaa90af4c2a8458718-7acb-82e9-e053-2995a90a4ef1
78048-002-10d6a99b39-f533-a426-e053-dadaa90af4c2a8458718-7acb-82e9-e053-2995a90a4ef1
78048-002-11d6a99b39-5a6e-a426-e053-dadaa90af4c2a847f0b1-426c-0d41-e053-2995a90ab6ad
78048-002-12d6a99b39-5a6e-a426-e053-dadaa90af4c2a847f0b1-426c-0d41-e053-2995a90ab6ad
78048-002-13d6a99b39-5a6e-a426-e053-dadaa90af4c2a847f0b1-426c-0d41-e053-2995a90ab6ad
78048-002-14d6a99b39-5a6e-a426-e053-dadaa90af4c2a847f0b1-426c-0d41-e053-2995a90ab6ad
78048-002-15d6a99b39-a902-a426-e053-dadaa90af4c2a85407cf-32f0-0ad1-e053-2995a90afb46
78048-002-16d6a99b39-a902-a426-e053-dadaa90af4c2a85407cf-32f0-0ad1-e053-2995a90afb46
78048-002-17d6a99b39-a902-a426-e053-dadaa90af4c2a85407cf-32f0-0ad1-e053-2995a90afb46
78048-002-18d6a99b39-a902-a426-e053-dadaa90af4c2a85407cf-32f0-0ad1-e053-2995a90afb46

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78048-002-01Hand Sanitizer50 mL in 1 BOTTLELIQUID502
78048-002-02Hand Sanitizer100 mL in 1 BOTTLELIQUID1002
78048-002-03Hand Sanitizer60 mL in 1 BOTTLELIQUID602
78048-002-04Hand Sanitizer120 mL in 1 BOTTLELIQUID1201
78048-002-05Hand Sanitizer250 mL in 1 BOTTLELIQUID2501
78048-002-06Hand Sanitizer500 mL in 1 BOTTLELIQUID5001
78048-002-07Hand Sanitizer30 mL in 1 BOTTLELIQUID301
78048-002-08Hand Sanitizer68 mL in 1 BOTTLELIQUID681
78048-002-09Hand Sanitizer80 mL in 1 BOTTLELIQUID801
78048-002-10Hand Sanitizer200 mL in 1 BOTTLELIQUID2001
78048-002-11Hand Sanitizer240 mL in 1 BOTTLELIQUID2401
78048-002-12Hand Sanitizer280 mL in 1 BOTTLELIQUID2801
78048-002-13Hand Sanitizer300 mL in 1 BOTTLELIQUID3001
78048-002-14Hand Sanitizer350 mL in 1 BOTTLELIQUID3501
78048-002-15Hand Sanitizer600 mL in 1 BOTTLELIQUID6001
78048-002-16Hand Sanitizer800 mL in 1 BOTTLELIQUID8001
78048-002-17Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001
78048-002-18Hand Sanitizer2000 mL in 1 BOTTLELIQUID20001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78048-002HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [DONGGUAN CITY DEXU TOYS CO.,LTD]2Legacy NDC, 3 package rows20200604_a72b4560-028f-7342-e053-2995a90a9901.zip
78048-002HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [DONGGUAN CITY DEXU TOYS CO.,LTD]1Legacy NDC, 4 package rows20200618_a847f0b1-426c-0d41-e053-2995a90ab6ad.zip
78048-002HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [DONGGUAN CITY DEXU TOYS CO.,LTD]1Legacy NDC, 3 package rows20200604_a72c5e02-3fac-446d-e053-2a95a90a0cda.zip
78048-002HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [DONGGUAN CITY DEXU TOYS CO.,LTD]1Legacy NDC, 4 package rows20200618_a85407cf-32f0-0ad1-e053-2995a90afb46.zip
78048-002HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [DONGGUAN CITY DEXU TOYS CO.,LTD]1Legacy NDC, 4 package rows20200618_a8458718-7acb-82e9-e053-2995a90a4ef1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSNa72b4560-028f-7342-e053-2995a90a99012
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCDa72b4560-028f-7342-e053-2995a90a99012
1039900isopropyl alcohol 75 % Topical SolutionSYa72b4560-028f-7342-e053-2995a90a99012
1039900isopropyl alcohol 75 % Topical SolutionPSNa72c5e02-3fac-446d-e053-2a95a90a0cda1
1039900isopropyl alcohol 75 % Topical SolutionPSNa8458718-7acb-82e9-e053-2995a90a4ef11
1039900isopropyl alcohol 75 % Topical SolutionPSNa847f0b1-426c-0d41-e053-2995a90ab6ad1
1039900isopropyl alcohol 75 % Topical SolutionPSNa85407cf-32f0-0ad1-e053-2995a90afb461
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCDa72c5e02-3fac-446d-e053-2a95a90a0cda1
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCDa8458718-7acb-82e9-e053-2995a90a4ef11
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCDa847f0b1-426c-0d41-e053-2995a90ab6ad1
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCDa85407cf-32f0-0ad1-e053-2995a90afb461
1039900isopropyl alcohol 75 % Topical SolutionSYa72c5e02-3fac-446d-e053-2a95a90a0cda1
1039900isopropyl alcohol 75 % Topical SolutionSYa8458718-7acb-82e9-e053-2995a90a4ef11
1039900isopropyl alcohol 75 % Topical SolutionSYa847f0b1-426c-0d41-e053-2995a90ab6ad1
1039900isopropyl alcohol 75 % Topical SolutionSYa85407cf-32f0-0ad1-e053-2995a90afb461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78048-002-1578048000215600 mL in 1 BOTTLE (78048-002-15) 600 ml2020-06-160000-00-00NoNoCurrent