DenTek Eugenol

Product NDC
83062-400
Requested package NDC
83062-400-21
11-digit product format
830620400
Labeler code
83062
Product ID
83062-400_eab5a54e-d02c-c5cb-e053-2995a90a7b21
Type
HUMAN OTC DRUG
Nonproprietary name
Eugenol
Dosage form
LIQUID
Route
DENTAL
Labeler
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-10-10
Marketing end
0000-00-00
Substance
EUGENOL
Active strength
850 mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage83062-40083062-400-21IInactivated by FDA2026-08-07

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83062-400-212024-01-30C16284748780-11030e365-0773-111a-e063-dadaa90a10e2DenTek Dental First Aid Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83062-400-20DenTek Eugenol3.5 mL in 1 VIAL, GLASSLIQUID3.51
83062-400-21DenTek Eugenol1 in 1 KITLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83062-400DENTEK EUGENOL (EUGENOL) LIQUID [IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.]1Legacy NDC, 2 package rows20221022_eab5a54e-d02b-c5cb-e053-2995a90a7b21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244327eugenol 85 % Dental SolutionPSNeab5a54e-d02b-c5cb-e053-2995a90a7b211
244327eugenol 850 MG/ML Topical SolutionSCDeab5a54e-d02b-c5cb-e053-2995a90a7b211
244327eugenol 85 % Dental SolutionSYeab5a54e-d02b-c5cb-e053-2995a90a7b211
244327eugenol 85 % Topical SolutionSYeab5a54e-d02b-c5cb-e053-2995a90a7b211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
83062-400-21830620400211 VIAL, GLASS in 1 KIT (83062-400-21) > 3.5 mL in 1 VIAL, GLASS (83062-400-20) 2022-10-100000-00-00NoNoCurrent