Thera Wise Natural Acne

Product NDC
43347-189
Requested package NDC
43347-189-01
11-digit product format
433470189
Labeler code
43347
Product ID
43347-189_9d615145-d202-4142-afc6-5c965864dfbe
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Derma Wise Skin Care Ltd.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-08-15
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
0 g/28g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43347-18943347-189-01IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 11 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43347-18943347-189-01IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43347-18943347-189-01IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43347-18943347-189-01IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43347-18943347-189-01IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43347-18943347-189-01IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43347-18943347-189-01IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43347-18943347-189-01IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43347-18943347-189-01IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43347-18943347-189-01IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43347-18943347-189-01IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage43347-18943347-189-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43347-189-012024-01-30C16284748780-11030e365-3ba8-111a-e063-dadaa90a10e2Théra Wise ® Natural Acne

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43347-189-01Thera Wise Natural Acne1 in 1 BOXOINTMENT13
43347-189-01Thera Wise Natural Acne28 g in 1 TUBEOINTMENT283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43347-189THERA WISE NATURAL ACNE (SALICYLIC ACID) OINTMENT [DERMA WISE SKIN CARE LTD.]3Legacy NDC, 2 package rows20220121_badcc3ef-d124-4f03-af61-362d9f64ef95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1804844salicylic acid 0.5 % Topical OintmentPSNbadcc3ef-d124-4f03-af61-362d9f64ef953
1804844salicylic acid 0.005 MG/MG Topical OintmentSCDbadcc3ef-d124-4f03-af61-362d9f64ef953
1804844salicylic acid 0.5 % Topical OintmentSYbadcc3ef-d124-4f03-af61-362d9f64ef953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43347-189-01433470189011 TUBE in 1 BOX (43347-189-01) > 28 g in 1 TUBE1 tube2016-08-150000-00-00NoNoCurrent