Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules

Product NDC
43553-0000
11-digit product format
435530000
Labeler code
43553
Product ID
43553-0000_b8a17775-e841-12ce-e053-2a95a90a2887
Type
HUMAN OTC DRUG
Nonproprietary name
POLOXAMER 188
Dosage form
LIQUID
Route
TOPICAL
Labeler
ConvaTec Inc
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-10-26
Marketing end
0000-00-00
Substance
POLOXAMER 188
Active strength
200 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct43553-0000IInactivated by FDA2026-08-17
excluded packagepackage43553-000043553-0000-0IInactivated by FDA2026-08-17

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 · 30 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 packagepackage43553-0000-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43553-0000-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43553-0000-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43553-0000-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43553-0000-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43553-0000-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43553-0000-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43553-0000-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43553-0000-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43553-0000-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43553-0000-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43553-0000-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43553-0000-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43553-0000-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43553-0000-01332a3947898…d4bfe170f9cd…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43553-0000-02023-01-30C16284748780-1f386c649-fe76-0266-e053-dadaa90a7c1aShur-Clens Skin Wound Cleanser 24 Count Single Dose Ampules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43553-0000-0Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules20 mL in 1 BOTTLE, UNIT-DOSELIQUID207
43553-0000-0Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules24 in 1 CARTONLIQUID247

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43553-0000SHUR CLENS SKIN WOUND CLEANSER 24 COUNT SINGLE DOSE AMPULES (POLOXAMER 188) LIQUID [CONVATEC INC]7Legacy NDC, 2 package rows20210112_b2fcc0ef-21a4-48ce-9536-b40e13ff8df9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1986876poloxamer 188 20 % Topical SolutionPSNb2fcc0ef-21a4-48ce-9536-b40e13ff8df97
1986881Shur-Clens 20 % Topical SolutionPSNb2fcc0ef-21a4-48ce-9536-b40e13ff8df97
1986881poloxamer 188 200 MG/ML Topical Solution [Shur-Clens]SBDb2fcc0ef-21a4-48ce-9536-b40e13ff8df97
1986876poloxamer 188 200 MG/ML Topical SolutionSCDb2fcc0ef-21a4-48ce-9536-b40e13ff8df97
1986876poloxamer 188 20 % Topical SolutionSYb2fcc0ef-21a4-48ce-9536-b40e13ff8df97
1986881Shur-Clens 200 MG/ML Topical SolutionSYb2fcc0ef-21a4-48ce-9536-b40e13ff8df97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43553-0000-04355300000024 BOTTLE, UNIT-DOSE in 1 CARTON (43553-0000-0) > 20 mL in 1 BOTTLE, UNIT-DOSE2017-10-260000-00-00NoNoCurrent