AURORA

Product NDC
63148-408
11-digit product format
631480408
Labeler code
63148
Product ID
63148-408_d918b33f-b4de-4bc2-b62c-bfe7c89cabe9
Type
HUMAN OTC DRUG
Nonproprietary name
ETHYL ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
APOLLO HEALTH AND BEAUTY CARE
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-01-13
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
650 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63148-408IInactivated by FDA2026-10-05
excluded packagepackage63148-40863148-408-02IInactivated 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 · 42 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 packagepackage63148-408-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63148-408-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63148-408-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63148-408-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63148-408-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63148-408-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63148-408-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63148-408-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63148-408-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63148-408-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63148-408-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63148-408-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63148-408-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63148-408-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63148-408-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63148-408-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63148-408-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63148-408-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63148-408-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63148-408-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63148-408-029bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-408-022020-01-31C16284748780-19d75b9d0-2c89-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-408-02AURORAANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE59 mL in 1 BOTTLE, PLASTICLIQUID591

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MAURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
ALCOHOLACTIVE MOIETY3K9958V90MAURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0AURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626QAURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208AURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LAURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSAURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
SULISOBENZONEINACTIVE INGREDIENT1W6L629B4KAURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
WATERINACTIVE INGREDIENT059QF0KO0RAURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-408AURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1Legacy NDC, 1 package rows20150115_fc640d39-9b6d-43dd-94fe-6dd72772bb0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884783ethanol 65 % Topical SolutionPSNfc640d39-9b6d-43dd-94fe-6dd72772bb0a1
884783ethanol 0.65 ML/ML Topical SolutionSCDfc640d39-9b6d-43dd-94fe-6dd72772bb0a1
884783ethanol 65 % Topical SolutionSYfc640d39-9b6d-43dd-94fe-6dd72772bb0a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63148-408-026314804080259 mL in 1 BOTTLE, PLASTIC59 mlHistorical