FREDS

Product NDC
55315-185
11-digit product format
553150185
Labeler code
55315
Product ID
55315-185_c6aa50b8-8560-480f-8af5-6cce5e883904
Type
HUMAN OTC DRUG
Nonproprietary name
TRICLOSAN
Dosage form
LIQUID
Route
TOPICAL
Labeler
FREDS INC.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-09-25
Marketing end
0000-00-00
Substance
TRICLOSAN
Active strength
0 mg/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct55315-185IInactivated by FDA2026-08-03
excluded packagepackage55315-18555315-185-08IInactivated by FDA2026-08-03

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55315-185-08IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55315-185-08IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55315-185-08IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55315-185-08IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55315-185-08IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55315-185-08IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55315-185-08IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55315-185-08IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55315-185-08IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55315-185-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55315-185-08IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55315-185-08IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55315-185-08IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55315-185-08IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55315-185-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55315-185-08IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55315-185-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55315-185-08IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55315-185-08IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55315-185-08IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55315-185-08IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55315-185-08EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55315-185-082020-01-31C16284748780-19d75b9cf-d7e7-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55315-185-08FREDSANTIBACTERIAL FRESH PEAR222 mL in 1 BOTTLE, PLASTICLIQUID2221

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
TRICLOSANACTIVE MOIETY4NM5039Y5XFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0BFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40FREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
POLYQUATERNIUM-10 (400 CPS AT 2%)INACTIVE INGREDIENTHB1401PQFSFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2FREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950URFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-185FREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]1Legacy NDC, 1 package rows20120928_ac8fa8b0-74af-421e-88a4-9cfe38a03bf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053855triclosan 0.46 % Medicated Liquid SoapPSNac8fa8b0-74af-421e-88a4-9cfe38a03bf41
1053855triclosan 4.6 MG/ML Medicated Liquid SoapSCDac8fa8b0-74af-421e-88a4-9cfe38a03bf41
1053855triclosan 0.46 % Foaming Medicated Hand SoapSYac8fa8b0-74af-421e-88a4-9cfe38a03bf41
1053855triclosan 0.46 % Medicated Liquid SoapSYac8fa8b0-74af-421e-88a4-9cfe38a03bf41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55315-185-0855315018508222 mL in 1 BOTTLE, PLASTIC222 mlHistorical