Aquafresh

Product NDC
0135-0604
11-digit product format
001350604
Labeler code
0135
Product ID
0135-0604_159951ee-7188-6795-e063-6294a90a314d
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-01
Substance
SODIUM FLUORIDE
Active strength
1.15 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aquafresh
Brand name suffix
Extreme Clean Pure Breath Action
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.15 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui1044547

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0604-01AquafreshExtreme Clean Pure Breath Action158.8 g in 1 TUBEPASTE158.85
0135-0604-01AquafreshExtreme Clean Pure Breath Action1 in 1 CARTONPASTE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0604AQUAFRESH EXTREME CLEAN PURE BREATH ACTION (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 2 package rows20240410_462eb309-deca-4464-b13a-7ae314e53ede.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044547sodium fluoride 0.25 % ToothpastePSN462eb309-deca-4464-b13a-7ae314e53ede5
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD462eb309-deca-4464-b13a-7ae314e53ede5
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY462eb309-deca-4464-b13a-7ae314e53ede5
1044547sodium fluoride 0.25 % ToothpasteSY462eb309-deca-4464-b13a-7ae314e53ede5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0604-01001350604011 TUBE in 1 CARTON (0135-0604-01) / 158.8 g in 1 TUBE1 tube2016-06-010000-00-00NoNoCurrent