FDA.reportPublic FDA data

AQUAFRESH

Product NDC
0135-0591
11-digit product format
001350591
Labeler code
0135
Product ID
0135-0591_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
2014-05-09
Substance
SODIUM FLUORIDE
Active strength
1.15 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
AQUAFRESH
Brand name suffix
EXTRA FRESH PLUS WHITENING
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1044547Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5484999c-8e6f-430d-99a5-6893a2489467Available on FDA.report

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
0135-0591-01AQUAFRESHEXTRA FRESH PLUS WHITENING1 in 1 CARTONPASTE19
0135-0591-01AQUAFRESHEXTRA FRESH PLUS WHITENING158.8 g in 1 TUBEPASTE158.89
0135-0591-02AQUAFRESHEXTRA FRESH PLUS WHITENING85.1 g in 1 TUBEPASTE85.19
0135-0591-02AQUAFRESHEXTRA FRESH PLUS WHITENING1 in 1 CARTONPASTE19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0591AQUAFRESH 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, 4 package rows20240301_5484999c-8e6f-430d-99a5-6893a2489467.zip

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 12 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Whitening Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.c25b6a95-e604-48e3-bc55-595969d1ce9b2025-12-23WarningsExact identifier
application number: M022
parodontax Active Gum RepairSTANNOUS FLUORIDEHaleon US Holdings LLCb51ccdd9-c0af-4caa-ad97-ad1d1423b76b2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLC59bb84d6-6fd3-4586-bccf-7dc45cbbb39c2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLCf6912712-ce9b-44aa-8953-b9a8d420f4582025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair WhiteningSTANNOUS FLUORIDEHaleon US Holdings LLC817e804c-e55e-4d77-9ab9-ff54ae7947252025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair Breath FreshenerSTANNOUS FLUORIDEHaleon US Holdings LLCaddcb1e2-24b9-4367-adf3-6806e2439a802025-12-22WarningsExact identifier
application number: M022
parodontaxSTANNOUS FLUORIDEHaleon US Holdings LLC0f07aa1a-97be-44af-92d8-a10777e24e0a2025-12-22WarningsExact identifier
application number: M022
R B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.410c40fd-cf94-0301-e063-6294a90ae2de2025-12-18WarningsExact identifier
application number: M022
Dem ZeroPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.411f1a0f-ed02-cc78-e063-6394a90a0aec2025-12-18WarningsExact identifier
application number: M022
Res B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.21469f58-1d70-774f-e063-6294a90af0392025-12-18WarningsExact identifier
application number: M022
Alzh LPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.41056de0-aaa2-01bb-e063-6394a90af7b82025-12-18WarningsExact identifier
application number: M022
LemonGLYCERINTwinMed LLCfc88eec0-c66c-5d6d-e053-6294a90a13d22025-12-18WarningsExact identifier
application number: M022
CloSYSHYDROGEN PEROXIDERowpar Pharmaceuticals, Inc.299fc7b1-af6d-4bf9-810f-d35283423fe22025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.c13761e0-d45d-4e0f-ac41-428e005f96bb2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.6dca566b-cb6a-43c4-b6e2-f2bad77fb9322025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.f36bb9bd-e9bc-4f35-a388-e0ffadbce6ab2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.7ede08e5-2dfe-4183-905d-28d1cea424072025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.9de36e4f-f966-4a58-b4bf-9ac3b86b3f092025-12-17WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDECVS PHARMACY, INC3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb22025-12-17WarningsExact identifier
application number: M022
Sore ThroatPHENOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)9128d59c-6fa9-4358-865a-802257a9bd252025-12-16WarningsExact identifier
application number: M022

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
0135-0591-01001350591011 TUBE in 1 CARTON (0135-0591-01) / 158.8 g in 1 TUBE1 tube2016-10-010000-00-00NoNoCurrent
0135-0591-02001350591021 TUBE in 1 CARTON (0135-0591-02) / 85.1 g in 1 TUBE1 tube2016-11-010000-00-00NoNoCurrent