FDA.reportPublic FDA data

DOWN Toothpaste,Gingersnap

Manufacturer
TAO CLEAN, LLC | Massco Dental
Effective date
2022-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:08

Label at a glance#

ProductUP Toothpaste,Lemon Citron
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and uses

aids in the prevention of dental cavities.

Dosage and administration

1 Wet toothbrush and apply a generous amount of your Whole Body Toothpaste 2 Brush thoroughly for 2 minutes. 3 Rinse and spit out paste after brushing. 4 Do not swallow.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24%

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or

contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.

Directions

DOSAGE & ADMINISTRATION SECTION

1 Wet toothbrush and apply a generous amount of your Whole Body Toothpaste

2 Brush thoroughly for 2 minutes.

3 Rinse and spit out paste after brushing.

4 Do not swallow.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients (up): Sorbitol, glycerin, xylitol, water, hydrated silica, chamomile, sodium carboxymethylcellulose, sodium methyl cocoyl taurate, sodium bicarbonate, lemon balm, titanium dioxide, stevia, sodium fluoride, benzoic acid, melatonin, L-Theanine

Inactive ingredients (down): sorbitol, glycerin, xylitol, hydrated silica, water, anthemis nobilis (chamomile), sodium bicarbonate, sodium carboxymethylcellulose, sodium methyl cocoyl taurate, lemon balm extract, titanium dioxide, stevia, benzoic acid, melatonin, l-theanine, nutmeg, ginger root, cinnamomum zeylanicum (cinnamon) oil

Attention

OTC - WHEN USING SECTION

Twist off cap to remove foil seal

Do not use if the safety seal is missing or broken

This product contains caffeine, which could be something to avoid if you are sensitive

For human use only

Need help with anything?

OTC - QUESTIONS SECTION

We want to help!

Talk to a human: +1 714 363 3599

Write to us: support@taoclean.com

Distributed by TAO Clean® LLC. Orange, CA 92866

Proudly made in the USA

UP TOOTHPASTE, LEMON CITRON, 60 ML 81301-0512-01 • DOWN TOOTHPASTE, GINGERSNAP, 60 ML 81301-0513-01

20352 • BA-0511-IM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Panel 1Panel 1Panel 2Panel 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81301-0512-22024-01-30C16284748780-11030e364-fdb2-111a-e063-dadaa90a10e2bb775b83-ace6-455d-e053-2995a90a828e
81301-0513-22024-01-30C16284748780-11030e364-fdb2-111a-e063-dadaa90a10e2bb775b83-ace6-455d-e053-2995a90a828e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81301-0512-1UP Toothpaste,Lemon Citron68.57 g in 1 TUBEPASTE, DENTIFRICE68.572
81301-0512-2UP Toothpaste,Lemon Citron1 in 1 BOXPASTE, DENTIFRICE12
81301-0513-1DOWN Toothpaste,Gingersnap68.57 g in 1 TUBEPASTE, DENTIFRICE68.572
81301-0513-2DOWN Toothpaste,Gingersnap1 in 1 BOXPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81301-0512UP TOOTHPASTE,LEMON CITRON (SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE DOWN TOOTHPASTE,GINGERSNAP (SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [TAO CLEAN, LLC]2Legacy NDC, 2 package rows20221022_bb775b83-ace6-455d-e053-2995a90a828e.zip
81301-0513UP TOOTHPASTE,LEMON CITRON (SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE DOWN TOOTHPASTE,GINGERSNAP (SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [TAO CLEAN, LLC]2Legacy NDC, 2 package rows20221022_bb775b83-ace6-455d-e053-2995a90a828e.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81301-051281301-0512-1, 81301-0512-2
81301-051381301-0513-1, 81301-0513-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEVIA LEAF6TC6NN0876IACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
PYRIDOXINEKV2JZ1BI6ZIACT
BENZOIC ACID8SKN0B0MIMIACT
THEANINE8021PR16QOIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM BICARBONATE8MDF5V39QOIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XYLITOLVCQ006KQ1EIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
CAFFEINE3G6A5W338EIACT
METHYLCOBALAMINBR1SN1JS2WIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
STEVIA LEAF6TC6NN0876IACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
BENZOIC ACID8SKN0B0MIMIACT
THEANINE8021PR16QOIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM BICARBONATE8MDF5V39QOIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XYLITOLVCQ006KQ1EIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
GINGERC5529G5JPQIACT
NUTMEGAEE24M3MQ9IACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
CHAMOMILEFGL3685T2XIACT
MELATONINJL5DK93RCLIACT
CINNAMON OILE5GY4I6YCZIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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
eb8858b1-c041-5cf7-e053-2995a90a30febb775b83-ace6-455d-e053-2995a90a828e2022-10-21WarningsExact identifier
spl id: eb8858b1-c041-5cf7-e053-2995a90a30fe
spl set id: bb775b83-ace6-455d-e053-2995a90a828e

Reported adverse events (FAERS/openFDA)#

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