FDA.reportPublic FDA data

Sensodyne Pronamel

Product NDC
0135-0818
Requested package NDC
0135-0818-01
11-digit product format
001350818
Labeler code
0135
Product ID
0135-0818_4394cf17-0793-a5c9-e063-6294a90a73c0
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Haleon US Holdings LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-15
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
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
Sensodyne Pronamel
Brand name suffix
Kids Bubble Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41b1e626-e79b-d638-e063-6394a90a1f5bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0818-01Sensodyne PronamelKids Bubble Mint113 g in 1 TUBEPASTE, DENTIFRICE1132
0135-0818-01Sensodyne PronamelKids Bubble Mint1 in 1 CARTONPASTE, DENTIFRICE12

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 28 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f69824-e886-6e7b-e063-6294a90acf772026-01-08WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.01f64874-6363-3dcc-e063-6394a90a2aec2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Fresh MintSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f27a63-15f3-cee4-e063-6394a90afa3b2026-01-08WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.01f618d7-be07-18c3-e063-6294a90a2d972026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f35279-76ce-6027-e063-6294a90a8e342026-01-08WarningsExact identifier
application number: M021
Crest SnowberrySTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company42ca1f06-3e7d-8fed-e063-6394a90afbff2026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.7d615c52-f9c9-4856-e053-2991aa0a79272026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.5a1bb1fb-12a5-5fd1-e053-2991aa0a628b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.8de12c9f-eb16-aa26-e053-2a95a90a1b9c2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Peppermint FrostSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company42c84772-d406-b6ca-e063-6394a90a920f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Sparkle MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company42cb1b2a-55ad-cb9c-e063-6294a90ac88c2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum RecessionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company47be4eff-1ab5-17a1-e063-6394a90ae4652026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TPSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25021787-44e8-0b29-e063-6394a90a0af62026-01-08WarningsExact identifier
application number: M021
Supersmile Professional whitening TP Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2502c305-71ab-bb71-e063-6394a90a0a842026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2502840c-82ee-12cb-e063-6394a90a5b3f2026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25039552-c35d-a69d-e063-6394a90ab1032026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2504686d-b053-51d0-e063-6394a90a789f2026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 8 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25121ebb-922b-719d-e063-6394a90a23d32026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf498b727-c38c-1d67-e053-2995a90a0f112026-01-08WarningsExact identifier
application number: M021
DG health Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEDolgencorp, LLC81cd5d37-3751-625f-e053-2a91aa0a6dfd2026-01-08WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-0818-01001350818011 TUBE in 1 CARTON (0135-0818-01) / 113 g in 1 TUBE1 tube2025-12-15NoNoCurrent