Organic Tea Tree Treatment Gel

Product NDC
71643-1019
11-digit product format
716431019
Labeler code
71643
Product ID
71643-1019_99889a4c-9d30-2b91-e053-2a95a90aeb0b
Type
HUMAN OTC DRUG
Nonproprietary name
salicylic acid 2% gel
Dosage form
GEL
Route
TOPICAL
Labeler
HERRCO COSMETICS LIMITED
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-09-26
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct71643-1019IInactivated by FDA2026-10-05
excluded packagepackage71643-101971643-1019-1IInactivated 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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71643-1019-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71643-1019-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71643-1019-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71643-1019-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71643-1019-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71643-1019-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage71643-1019-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage71643-1019-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage71643-1019-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage71643-1019-18dfbde2a14a4…c9ff85d89658…

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
71643-1019-12024-12-24C16284748780-1ba0f9c33-1620-a910-e053-dadaa90a0b85Organic Tea Tree Treatment Gel
71643-1019-12021-01-29C16284748780-1ba0f9c33-1620-a910-e053-dadaa90a0b85Organic Tea Tree Treatment Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71643-1019-1Organic Tea Tree Treatment Gel10 mL in 1 BOXGEL103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71643-1019ORGANIC TEA TREE TREATMENT GEL (SALICYLIC ACID 2% GEL) GEL [HERRCO COSMETICS LIMITED]3Legacy NDC, 1 package rows20241226_5900c07c-2e6f-3f2b-e053-2a91aa0a95ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSN5900c07c-2e6f-3f2b-e053-2a91aa0a95ff3
346298salicylic acid 0.02 MG/MG Topical GelSCD5900c07c-2e6f-3f2b-e053-2a91aa0a95ff3
346298salicylic acid 2 % Topical GelSY5900c07c-2e6f-3f2b-e053-2a91aa0a95ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
71643-1019-17164310190110 mL in 1 BOX10 mlHistorical