FDA.reportPublic FDA data

Peppermint Twist

Manufacturer
Caldwell Health LLC | GORAN PHARMA PRIVATE LIMITED
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:07:28

Label at a glance#

ProductPeppermint Twist
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Storage and handling

Other information Store standing up with cap tightly closed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sodium fluoride (0.24%) (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Use

Aids in the prevention of dental cavities.

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if the safety seal is missing or broken.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and olderBrush teeth thoroughly, preferably after each meal or at least twice or as directed by a dentist or physician.
Children 2 to 6 yearsUse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 yearsAsk a dentist or physician.

STORAGE AND HANDLING SECTION

Other information

Store standing up with cap tightly closed.

INACTIVE INGREDIENT SECTION

Inactive ingredients Glycerin, hydrated silica, sorbitol, water, xylitol, Aloe barbadensis leaf juice, cocamidopropyl betaine, sodium cocoylglycinate, cellulose gum, titanium dioxide, Echinacea angustifolia extract, natural flavors (contains Cinnamomum cassie leaf oil), Hydrastis canadensis (goldenseal) extract, Calendula officinalis extract, xanthan gum, citric acid, zinc citrate, Citrus grandis (grapefruit) seed extract.

OTC - QUESTIONS SECTION

Questions? Call 1-888-317-4402, weekdays 9 to 5 ET.

SPL UNCLASSIFIED SECTION

Manufactured for Revive Personal Products Company,

Allendale, NJ 07401

© 2018 Revive Personal Products Company.
Made in USA. Vegan. Not tested on animals.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NO SLS!

THE NATURAL DENTIST

ALL IN ONE

FLUORIDE TOOTHPASTE

with Purified Aloe Vera

  • Prevents Cavities
  • Whitens Teeth
  • Strengthens Tooth Enamel
  • Fights Tartar
  • Freshens Breath

PEPPERMINT TWIST

NET WT. 5.0 OZ (141g)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN6
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD6
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY6
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY6
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY6
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
34362-0237-22021-12-29C16284748780-1ab0e2407-2869-f274-e053-dbdaa90a6471The Natural Dentist All in One Toothpaste
34362-0237-22020-09-27C16284748780-1ab0e2407-2869-f274-e053-dbdaa90a6471The Natural Dentist All in One Toothpaste
34362-0237-22020-09-25C16284748780-1ab0e2407-2869-f274-e053-dbdaa90a6471The Natural Dentist All in One Toothpaste
34362-0237-22020-07-22C16284748780-1ab0e2407-2869-f274-e053-dbdaa90a6471The 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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34362-023734362-0237-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM COCOYL GLYCINATEXLU9KH03XMIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8IACT
GOLDENSEALZW3Z11D0JVIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ZINC CITRATEK72I3DEX9BIACT
CITRUS MAXIMA SEED083X55C543IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
ndc (package): 34362-0237-2
ndc (product): 34362-0237
ndc11 (package): 34362023702
spl id: b77af517-6beb-40b7-bfc6-18f517f96a78
spl set id: 4b28cdd1-0dba-42f5-a9e8-06d9e75b2396

Reported adverse events (FAERS/openFDA)#

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