FDA.reportPublic FDA data

AQUAFRESH

Product NDC
0135-0590
11-digit product format
001350590
Labeler code
0135
Product ID
0135-0590_4af361ee-0754-8996-e063-6294a90aab2d
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
2016-10-01
Substance
SODIUM FLUORIDE
Active strength
1.15 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AQUAFRESH
Brand name suffix
CAVITY PROTECTION
Listing expiration
2027-12-31

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
0135-0590-01AQUAFRESHCAVITY PROTECTION1 in 1 CARTONPASTE19
0135-0590-01AQUAFRESHCAVITY PROTECTION158.8 g in 1 TUBEPASTE158.89
0135-0590-02AQUAFRESHCAVITY PROTECTION85 g in 1 TUBEPASTE859
0135-0590-02AQUAFRESHCAVITY PROTECTION1 in 1 CARTONPASTE19
0135-0590-04AQUAFRESHCAVITY PROTECTION2 in 1 CARTONPASTE29
0135-0590-04AQUAFRESHCAVITY PROTECTION158.8 g in 1 TUBEPASTE158.89
0135-0590-05AQUAFRESHCAVITY PROTECTION3 in 1 CARTONPASTE39
0135-0590-05AQUAFRESHCAVITY PROTECTION158.8 g in 1 TUBEPASTE158.89

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0590-01GM - Gram0135-05901940ca89-d69b-4796-8903-054698db6af312022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0590AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH MULTI ACTION WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 8 package rows20240301_5484999c-8e6f-430d-99a5-6893a2489467.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044547sodium fluoride 0.25 % ToothpastePSN5484999c-8e6f-430d-99a5-6893a24894679
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD5484999c-8e6f-430d-99a5-6893a24894679
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY5484999c-8e6f-430d-99a5-6893a24894679
1044547sodium fluoride 0.25 % ToothpasteSY5484999c-8e6f-430d-99a5-6893a24894679

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0590-01001350590011 TUBE in 1 CARTON (0135-0590-01) / 158.8 g in 1 TUBE1 tube2016-10-010000-00-00NoNoCurrent
0135-0590-02001350590021 TUBE in 1 CARTON (0135-0590-02) / 85 g in 1 TUBE1 tube2016-11-010000-00-00NoNoCurrent
0135-0590-04001350590042 TUBE in 1 CARTON (0135-0590-04) / 158.8 g in 1 TUBE2 tube2016-11-010000-00-00NoNoCurrent
0135-0590-05001350590053 TUBE in 1 CARTON (0135-0590-05) / 158.8 g in 1 TUBE3 tube2021-02-28NoNoHistorical