FDA.reportPublic FDA data

A and H Plus TheraBreath

Manufacturer
Church & Dwight Co., Inc.
Effective date
2026-04-23
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:55:41

Label at a glance#

ProductA and H Plus Therabreath Breath Freshners
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

do not swallow supervise children as necessary until capable of using without supervision rinse away toothpaste residue thoroughly after brushing adults and children 6 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24% (0.17% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental decay

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use ifirritation occurs and persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not swallow
  • supervise children as necessary until capable of using without supervision
  • rinse away toothpaste residue thoroughly after brushing

adults and children 6 years and older

brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, flavor, sodium lauryl sulfate, sodium lauroyl sarcosinate, poloxamer 407, sodium saccharin, xanthan gum, titanium dioxide, sodium chlorite.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-786-5135Mon.–Fri. 9am–5pm ET or visit www.myoralcare.com

PRINCIPAL DISPLAY PANEL - 156 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

Anticavity
Fluoride
Toothpaste

ARM & HAMMER
THE STANDARD OF PURITY

plus

TheraBreath ™
BREATH FRESHENERS

helps kill bad breath bacteria*

whitening

Invigorating
Icy Mint

NET WT
5.5 OZ (156 g)

PRINCIPAL DISPLAY PANEL - 156 g Tube Carton
PRINCIPAL DISPLAY PANEL - 156 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN9
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD9
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY9
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY9
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-676-09A and H Plus Therabreath Breath Freshners1 in 1 CARTONPASTE, DENTIFRICE19
10237-676-09A and H Plus Therabreath Breath Freshners25.5 g in 1 TUBEPASTE, DENTIFRICE25.59
10237-676-45A and H Plus Therabreath Breath Freshners1 in 1 CARTONPASTE, DENTIFRICE19
10237-676-45A and H Plus Therabreath Breath Freshners4 in 1 PACKAGEPASTE, DENTIFRICE49
10237-676-51A and H Plus Therabreath Breath Freshners1 in 1 CARTONPASTE, DENTIFRICE19
10237-676-51A and H Plus Therabreath Breath Freshners5 in 1 CELLO PACKPASTE, DENTIFRICE59
10237-676-55A and H Plus Therabreath Breath Freshners1 in 1 CARTONPASTE, DENTIFRICE19
10237-676-55A and H Plus Therabreath Breath Freshners156 g in 1 TUBEPASTE, DENTIFRICE1569
10237-676-56A and H Plus Therabreath Breath Freshners2 in 1 CARTONPASTE, DENTIFRICE29
10237-676-56A and H Plus Therabreath Breath Freshners156 g in 1 TUBEPASTE, DENTIFRICE1569

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-67610237-676-55, 10237-676-51, 10237-676-56, 10237-676-09, 10237-676-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURYL SARCOSINATE5PGH842FAUIACT
POLOXAMER 407TUF2IVW3M2IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM CHLORITEG538EBV4VFIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82026-02-23monthly-update2026-06-03 18:00:29

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
A and H Plus Therabreath Breath FreshnersSODIUM FLUORIDEChurch & Dwight Co., Inc.18d6073e-b1ee-47d2-9758-2cf04f3cf3ca2026-04-23WarningsExact identifier
ndc (package): 10237-676-56
ndc (package): 10237-676-51
ndc (package): 10237-676-45
ndc (package): 10237-676-09
ndc (package): 10237-676-55
ndc (product): 10237-676
ndc11 (package): 10237067655
ndc11 (package): 10237067651
ndc11 (package): 10237067656
ndc11 (package): 10237067645
ndc11 (package): 10237067609
spl id: 501aaf53-e8df-0380-e063-6394a90aca25
spl set id: 18d6073e-b1ee-47d2-9758-2cf04f3cf3ca

Reported adverse events (FAERS/openFDA)#

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