FDA.reportPublic FDA data

Peppermint Twist

Product NDC
34362-0237
Requested package NDC
34362-0237-2
11-digit product format
343620237
Labeler code
34362
Product ID
34362-0237_b77af517-6beb-40b7-bfc6-18f517f96a78
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Caldwell Health LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-11
Substance
SODIUM FLUORIDE
Active strength
.243 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage34362-023734362-0237-2IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage34362-023734362-0237-2IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Peppermint Twist
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.243 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b28cdd1-0dba-42f5-a9e8-06d9e75b2396Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-12-29The Natural Dentist All in One Toothpaste
2020-09-27The Natural Dentist All in One Toothpaste
2020-09-25The Natural Dentist All in One Toothpaste
2020-07-22The Natural Dentist All in One Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34362-0237-2Peppermint Twist1 in 1 BOXPASTE, DENTIFRICE16
34362-0237-2Peppermint Twist142 g in 1 TUBEPASTE, DENTIFRICE1426

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34362-0237PEPPERMINT TWIST (FLUORIDE) PASTE, DENTIFRICE [CALDWELL HEALTH LLC]6Current NDC, Legacy NDC, 2 package rows20240118_4b28cdd1-0dba-42f5-a9e8-06d9e75b2396.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 39 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORCA Pain Reliever Putty with MentholMENTHOLORCA Products, LLC188cb01a-3d0f-43d9-983e-6475c0c5b06e2023-11-10WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC33fbdbc7-e10d-4181-926f-9b591b5b07e32023-11-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0d2c8c0c-4c72-4400-b3b5-ed578fa351672023-11-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDegasa, S.A. de C.V.45ac0275-4c68-3897-e054-00144ff8d46c2023-11-05WarningsExact identifier
application number: M022
Oral Pain ReliefBENZOCAINEGERI-CARE PHARMACEUTICAL CORPd294a39e-55f4-272d-e053-2995a90ab7f72023-10-31WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.e10c45e6-d37f-4650-b3e5-07719cc0ea492023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.886d949b-8db1-499c-a277-174f8bc29f342023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.fc8194af-2e77-4ad1-ae75-461dce3ed6042023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.baf7d184-07ed-4491-a1fc-9a377b4b01102023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.033034af-c86c-4dbf-90eb-009c117024c62023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.658ada18-2334-4b4e-b08e-702fa127aa142023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.cad932e5-8d7f-4f20-b1c2-febd328152f02023-10-11WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.2c9519ab-320d-49da-9deb-97a6168fb0882023-10-10WarningsExact identifier
application number: M022
IolineBENZOCAINEDharma Research, Inc.b862c974-c024-42c3-986e-b65069437c7b2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.651ea978-081d-4c59-b177-6049a69d94152023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.db763237-2910-45b9-be72-da092edc951b2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.34316f93-10b4-41cc-8654-625283f0044c2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.142a8824-657e-492a-8e5a-b15eb73383c92023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.414cbec9-94e2-4bca-908b-1e79f8db0b272023-10-10WarningsExact identifier
application number: M022
Sore throat cherryPHENOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)de634cf1-ed39-4d8a-8855-006c69b7aee92023-10-10WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN4b28cdd1-0dba-42f5-a9e8-06d9e75b23966
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD4b28cdd1-0dba-42f5-a9e8-06d9e75b23966
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY4b28cdd1-0dba-42f5-a9e8-06d9e75b23966
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY4b28cdd1-0dba-42f5-a9e8-06d9e75b23966
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4b28cdd1-0dba-42f5-a9e8-06d9e75b23966
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY4b28cdd1-0dba-42f5-a9e8-06d9e75b23966

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34362-0237-2343620237021 TUBE in 1 BOX (34362-0237-2) / 142 g in 1 TUBE1 tube2018-04-110000-00-00NoNoCurrent