FDA.reportPublic FDA data

AMERFRESH FLUORIDE

Product NDC
85162-002
11-digit product format
851620002
Labeler code
85162
Product ID
85162-002_2bce0fcd-1d50-cf52-e063-6394a90a3603
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Yangzhou ONE & ONLY Personal Care Products Co., LTD
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-16
Substance
SODIUM FLUORIDE
Active strength
.1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
AMERFRESH FLUORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 g/100g

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
245598Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
827e45bb-84c0-48ee-a60b-2cc32b8f33e3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85162-002-01AMERFRESH FLUORIDE17 g in 1 TUBEPASTE, DENTIFRICE171
85162-002-01AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-02AMERFRESH FLUORIDE24 g in 1 TUBEPASTE, DENTIFRICE241
85162-002-02AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-03AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-03AMERFRESH FLUORIDE43 g in 1 TUBEPASTE, DENTIFRICE431
85162-002-04AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-04AMERFRESH FLUORIDE78 g in 1 TUBEPASTE, DENTIFRICE781
85162-002-05AMERFRESH FLUORIDE85 g in 1 TUBEPASTE, DENTIFRICE851
85162-002-05AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-06AMERFRESH FLUORIDE142 g in 1 TUBEPASTE, DENTIFRICE1421
85162-002-06AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-07AMERFRESH FLUORIDE7 g in 1 POUCHPASTE, DENTIFRICE71
85162-002-07AMERFRESH FLUORIDE1000 in 1 BOXPASTE, DENTIFRICE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85162-002AMERFRESH FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD]1Current NDC, 14 package rows20250117_827e45bb-84c0-48ee-a60b-2cc32b8f33e3.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 20 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Cavity Protection Great Regular FlavorANTICAVITY FLUORIDE TOOTHPASTEColgate-Palmolive Company202c6c62-e16a-4716-babe-d5414006c79e2026-01-21WarningsExact identifier
application number: M021
Crest 3D White Luxe Diamond StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc1420129-5460-4900-ac9a-356d2d7c60a22026-01-21WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Max Cavity and Erosion PreventionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company48eb0bdc-7399-745d-e063-6294a90a98092026-01-21WarningsExact identifier
application number: M021
Colgate Total Gum Protect WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companydcf81dcb-b26b-4411-82d4-5f7e9d3fc0f32026-01-20WarningsExact identifier
application number: M021
GuruNanda Anti-CavitySODIUM FLUORIDEGURUNANDA, LLC3b07b72f-4efc-eb0f-e063-6294a90a70a82026-01-19WarningsExact identifier
application number: M021
GuruNanda AnticavitySODIUM FLUORIDEGURUNANDA, LLC3e90d516-3172-3c8d-e063-6294a90a394f2026-01-19WarningsExact identifier
application number: M021
HismilePEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0eba92d1-cbdc-9c96-e063-6294a90a9afc2026-01-15WarningsExact identifier
application number: M021
HismileCOCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3cfb6-6bae-1682-e063-6394a90aca882026-01-15WarningsExact identifier
application number: M021
HismileMANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3f4f8-fdc4-2056-e063-6394a90a6fd72026-01-15WarningsExact identifier
application number: M021
HismileSMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef41051-dfa0-b105-e063-6294a90a551f2026-01-15WarningsExact identifier
application number: M021
HismileWATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef43107-58ec-d4ee-e063-6294a90ad8d72026-01-15WarningsExact identifier
application number: M021
HismileRED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef56539-dc21-c6ea-e063-6394a90a57902026-01-15WarningsExact identifier
application number: M021
HismileGRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef6f8b5-8565-b364-e063-6294a90aabbc2026-01-15WarningsExact identifier
application number: M021
HismileSTRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef766ae-754a-f185-e063-6294a90a32992026-01-15WarningsExact identifier
application number: M021
HismileBANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef7be5b-df8f-9f32-e063-6394a90a47242026-01-15WarningsExact identifier
application number: M021
HismileVANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef8d0ef-a051-f610-e063-6394a90a85372026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d40b98b-2e9a-d84a-e063-6294a90a20962026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d44863e-93be-2b80-e063-6294a90a4a9d2026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d458ccc-8f1e-f9c8-e063-6294a90a8da42026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d447939-fbf6-42f6-e063-6294a90af6d92026-01-15WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN827e45bb-84c0-48ee-a60b-2cc32b8f33e31
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD827e45bb-84c0-48ee-a60b-2cc32b8f33e31
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY827e45bb-84c0-48ee-a60b-2cc32b8f33e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85162-002-0185162000201144 TUBE in 1 BOX (85162-002-01) / 17 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-0285162000202144 TUBE in 1 BOX (85162-002-02) / 24 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-0385162000203144 TUBE in 1 BOX (85162-002-03) / 43 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-0485162000204144 TUBE in 1 BOX (85162-002-04) / 78 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-0585162000205144 TUBE in 1 BOX (85162-002-05) / 85 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-0685162000206144 TUBE in 1 BOX (85162-002-06) / 142 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-07851620002071000 POUCH in 1 BOX (85162-002-07) / 7 g in 1 POUCH1000 pouch2025-01-16NoNoCurrent