Home NDC 87053-007 Prime Tooth Care Summer Watermelon
Product NDC 87053-007
11-digit product format 870530007
Labeler code 87053
Product ID 87053-007_47f523e0-e81d-4426-e063-6294a90a344d
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form OINTMENT
Route DENTAL
Labeler Prime Tooth Care LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-31
Substance SODIUM FLUORIDE
Active strength 2.5 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 Prime Tooth Care Summer Watermelon
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 2.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 87053-007-00 Prime Tooth Care Summer Watermelon 65 g in 1 TUBE OINTMENT 65 2 87053-007-00 Prime Tooth Care Summer Watermelon 1 in 1 BOX OINTMENT 1 2
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 32 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Advance White Extreme Whitening Tartar Control SODIUM FLUORIDE Church & Dwight Co., Inc. b539264f-e1ff-440b-af76-84266fe2c0a2 2025-12-02 Warnings Exact identifier application number: M021 Sensodyne Pronamel Clinical Enamel Strength Fresh Breath POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC 34a1a32e-3017-f018-e063-6394a90a0230 2025-12-01 Warnings Exact identifier application number: M021 PRO-SYS SODIUM FLUORIDE AND POTASSIUM NITRATE Benco Dental 4e470ba4-60bb-1815-e063-6294a90abacc 2025-12-01 Warnings Exact identifier application number: M021 PRO-SYS SODIUM FLUORIDE Benco Dental 4e539cb2-bcbd-95fc-e063-6294a90a2121 2025-12-01 Warnings Exact identifier application number: M021 Cool sense Care Plus SODIUM FLUORIDE DONG IL PHARMS CO., LTD. 44763bf6-caf3-ec69-e063-6394a90a0ee1 2025-11-25 Warnings Exact identifier application number: M021 DOCTRUST DOUBLEX Tooth SODIUM FLUORIDE DONG IL PHARMS CO.,LTD 44765e86-2eb2-6381-e063-6394a90a761f 2025-11-25 Warnings Exact identifier application number: M021 TheraBreath for Kids Anticavity Wacky Watermelon SODIUM FLUORIDE Church & Dwight Co., Inc. 578f8010-6b1c-4c6b-91d3-e483ace40f66 2025-11-25 Warnings Exact identifier application number: M021 Sensodyne Cavity and Sensitivity POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC d002074b-0580-4247-b3c7-121b8c098697 2025-11-24 Warnings Exact identifier application number: M021 CVS Pharmacy Enamel Guard FLUORIDE CVS Pharmacy 18295a1c-c2a6-489b-be34-9252b9e1e2b8 2025-11-21 Warnings Exact identifier application number: M021 365 Everyday Value Cavity Fighting and Whitening SODIUM MONOFLOUROPHOSPHATE Whole Foods Market, Inc. 83704717-19bc-2634-e053-2991aa0a2979 2025-11-21 Warnings Exact identifier application number: M021 Whitening MONOFLUOROPHOSPHATE Target 0074630f-9d8d-9209-e063-6294a90a4f01 2025-11-21 Warnings Exact identifier application number: M021 Rite Aid Enamel Guard FLUORIDE Rite Aid 67c1fc04-0f21-4944-8b9d-0d8ffd051874 2025-11-21 Warnings Exact identifier application number: M021 ME MOTHER EARTH ZERO WASTE TOOTHPASTE TABLETS PEPPERMINT A PLUS MERCHANDISE LLC 43d30abc-889a-5377-e063-6294a90ab804 2025-11-17 Warnings Exact identifier application number: M021 Natural White Sensitivity and Gum STANNOUS FLUORIDE Lornamead Products 2e83bda8-4d4b-640f-e063-6294a90abc60 2025-11-14 Warnings Exact identifier application number: M021 CVS Pharmacy Restore and Defend FLUORIDE CVS Pharmacy 99f86135-05b7-42b1-aef5-df4513259b8f 2025-11-14 Warnings Exact identifier application number: M021 HEB HEBuddy FLUORIDE HEB a6af1baf-17bf-428c-8744-1490359b0cfb 2025-11-13 Warnings Exact identifier application number: M021 Spearmint Whitening with Hemp Oil SODIUM MONOFLUOROPHOSPHATE Whole Foods a4714db7-abc4-1eff-e053-2995a90a7740 2025-11-13 Warnings Exact identifier application number: M021 Complete Protection TP STANNOUS FLUORIDE Rite Aid ccad28b5-254e-679f-e053-2a95a90abdd5 2025-11-13 Warnings Exact identifier application number: M021 Rite Aid Sensitivity and Gum STANNOUS FLUORIDE Rite Aid ed362e9c-2dab-1102-e053-2a95a90a76f3 2025-11-13 Warnings Exact identifier application number: M021 Gum Detoxify STANNOUS FLUORIDE Meijer, Inc. 0338495b-08a5-047f-e063-6394a90aa124 2025-11-13 Warnings Exact identifier application number: M021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87053-007-00 87053000700 1 TUBE in 1 BOX (87053-007-00) / 65 g in 1 TUBE 1 tube 2025-08-31 No No Current