Home NDC 34362-0237-2 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 34362-0237 34362-0237-2 I Inactivated by FDA excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 34362-0237 34362-0237-2 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…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 Ingredient Strength SODIUM FLUORIDE .243 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 891775 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 34362-0237-2 Peppermint Twist 1 in 1 BOX PASTE, DENTIFRICE 1 6 34362-0237-2 Peppermint Twist 142 g in 1 TUBE PASTE, DENTIFRICE 142 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 34362-0237 PEPPERMINT TWIST (FLUORIDE) PASTE, DENTIFRICE [CALDWELL HEALTH LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240118_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 9 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 34362-0237-2 34362023702 1 TUBE in 1 BOX (34362-0237-2) / 142 g in 1 TUBE 1 tube 2018-04-11 0000-00-00 No No Current