AURORA

Product NDC
63148-103
11-digit product format
631480103
Labeler code
63148
Product ID
63148-103_a87ca218-361f-48d3-87de-79749e242850
Type
HUMAN OTC DRUG
Nonproprietary name
TRICLOSAN
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
TRICLOSAN
Active strength
5 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 productproduct63148-103IInactivated by FDA2026-10-05
excluded packagepackage63148-10363148-103-08IInactivated 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 · 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 packagepackage63148-103-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63148-103-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63148-103-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63148-103-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63148-103-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63148-103-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63148-103-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63148-103-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63148-103-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63148-103-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63148-103-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63148-103-08557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63148-103-088af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63148-103-08834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63148-103-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63148-103-08fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63148-103-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63148-103-08bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63148-103-088dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63148-103-08e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63148-103-089bebd1f3094a…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
63148-103-082020-01-31C16284748780-19d75b9d1-0915-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-103-08AURORAANTIBACTERIAL JAPANESE FLOWER GARDEN237 mL in 1 BOTTLE, PLASTICLIQUID2371

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
TRICLOSANACTIVE MOIETY4NM5039Y5XAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
PEG-7 GLYCERYL COCOATEINACTIVE INGREDIENTVNX7251543AURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)INACTIVE INGREDIENT0L414VCS5YAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0AURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
SULISOBENZONEINACTIVE INGREDIENT1W6L629B4KAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1
WATERINACTIVE INGREDIENT059QF0KO0RAURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-103AURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN (TRICLOSAN) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1Legacy NDC, 1 package rows20150116_bb6ca63d-067a-48a1-83c3-2c5d45ec35ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053855triclosan 0.46 % Medicated Liquid SoapPSNbb6ca63d-067a-48a1-83c3-2c5d45ec35ee1
1053855triclosan 4.6 MG/ML Medicated Liquid SoapSCDbb6ca63d-067a-48a1-83c3-2c5d45ec35ee1
1053855triclosan 0.46 % Foaming Medicated Hand SoapSYbb6ca63d-067a-48a1-83c3-2c5d45ec35ee1
1053855triclosan 0.46 % Medicated Liquid SoapSYbb6ca63d-067a-48a1-83c3-2c5d45ec35ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63148-103-0863148010308237 mL in 1 BOTTLE, PLASTIC237 mlHistorical