FDA.reportPublic FDA data

Hoo gargle (Rooibos Tea Flavor)(Mouthwash)

Product NDC
81840-2222
Requested package NDC
81840-2222-5
11-digit product format
818402222
Labeler code
81840
Product ID
81840-2222_eb5dcd3f-176c-1808-e053-2995a90a44f2
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Flouride
Dosage form
LIQUID
Route
DENTAL
Labeler
MIKO CO LTD
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-07-03
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 g/100mL
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 packagepackage81840-222281840-2222-5IInactivated 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 · 11 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…

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
81840-2222-52024-07-30C16284748780-11030e365-186f-111a-e063-dadaa90a10e2Drug Facts
81840-2222-52024-01-30C16284748780-11030e365-186f-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81840-2222-0Hoo gargle (Rooibos Tea Flavor)(Mouthwash)10 mL in 1 POUCHLIQUID104
81840-2222-1Hoo gargle (Rooibos Tea Flavor)(Mouthwash)10 in 1 PACKAGELIQUID104
81840-2222-2Hoo gargle (Rooibos Tea Flavor)(Mouthwash)15 in 1 PACKAGELIQUID154
81840-2222-3Hoo gargle (Rooibos Tea Flavor)(Mouthwash)30 in 1 PACKAGELIQUID304
81840-2222-4Hoo gargle (Rooibos Tea Flavor)(Mouthwash)50 in 1 PACKAGELIQUID504
81840-2222-5Hoo gargle (Rooibos Tea Flavor)(Mouthwash)100 in 1 PACKAGELIQUID1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81840-2222HOO GARGLE (ROOIBOS TEA FLAVOR)(MOUTHWASH) (SODIUM FLOURIDE) LIQUID [MIKO CO LTD]4Legacy NDC, 6 package rows20231007_e9145a59-c7b4-48ac-e053-2a95a90a0bb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNe9145a59-c7b4-48ac-e053-2a95a90a0bb34
313029sodium fluoride 0.2 MG/ML MouthwashSCDe9145a59-c7b4-48ac-e053-2a95a90a0bb34
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYe9145a59-c7b4-48ac-e053-2a95a90a0bb34
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYe9145a59-c7b4-48ac-e053-2a95a90a0bb34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81840-2222-581840222205100 PACKAGE in 1 PACKAGE (81840-2222-5) > 50 PACKAGE in 1 PACKAGE (81840-2222-4) > 30 PACKAGE in 1 PACKAGE (81840-2222-3) > 15 PACKAGE in 1 PACKAGE (81840-2222-2) > 10 POUCH in 1 PACKAGE (81840-2222-1) > 10 mL in 1 POUCH (81840-2222-0) 100 package2022-09-200000-00-00NoNoCurrent