Home NDC 10237-677 Orajel Complete Protection
Product NDC 10237-677
11-digit product format 102370677
Labeler code 10237
Product ID 10237-677_1b5ce44b-79ef-4d10-b4a0-2b8c3dd67edd
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE
Route ORAL
Labeler Church & Dwight Co., Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength .243; 5 g/100g; 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 Orajel Complete Protection
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .243 g/100g POTASSIUM NITRATE 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z 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 10237-677-12 Orajel Complete Protection 170 g in 1 TUBE PASTE 170 3 10237-677-12 Orajel Complete Protection 2 in 1 CARTON PASTE 2 3 10237-677-43 Orajel Complete Protection 121.9 g in 1 TUBE PASTE 121.9 3 10237-677-43 Orajel Complete Protection 1 in 1 CARTON PASTE 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-677 ORAJEL COMPLETE PROTECTION (SODIUM FLUORIDE) PASTE [CHURCH & DWIGHT CO., INC.] 3 Current NDC, 4 package rows 20240404_daebd16f-d278-446d-8b7a-33add5a74fdd.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 29 of 51 · 1,013 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Crest 3D White Stain Eraser Icy Clean Mint SODIUM FLUORIDE Procter & Gamble Manufacturing Mxico, S. de R.L. de C.V. 8de12c9f-eb16-aa26-e053-2a95a90a1b9c 2026-01-08 Warnings Exact identifier application number: M021 Crest Pro Health Peppermint Frost STANNOUS FLUORIDE The Procter & Gamble Manufacturing Company 42c84772-d406-b6ca-e063-6394a90a920f 2026-01-08 Warnings Exact identifier application number: M021 Crest 3D White Sparkle Mint SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 42cb1b2a-55ad-cb9c-e063-6294a90ac88c 2026-01-08 Warnings Exact identifier application number: M021 Crest Pro-Health Gum Recession STANNOUS FLUORIDE The Procter & Gamble Manufacturing Company 47be4eff-1ab5-17a1-e063-6394a90ae465 2026-01-08 Warnings Exact identifier application number: M021 Supersmile Professional Whitening TP SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 25021787-44e8-0b29-e063-6394a90a0af6 2026-01-08 Warnings Exact identifier application number: M021 Supersmile Professional whitening TP Original Mint SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 2502c305-71ab-bb71-e063-6394a90a0a84 2026-01-08 Warnings Exact identifier application number: M021 Supersmile Professional Whitening TP Original Mint SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 2502840c-82ee-12cb-e063-6394a90a5b3f 2026-01-08 Warnings Exact identifier application number: M021 Supersmile Professional Whitening TP Citrus Blast SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 25039552-c35d-a69d-e063-6394a90ab103 2026-01-08 Warnings Exact identifier application number: M021 Supersmile Professional Whitening TP Citrus Blast SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 2504686d-b053-51d0-e063-6394a90a789f 2026-01-08 Warnings Exact identifier application number: M021 Supersmile Professional Whitening TP Peppy Mint 8 oz SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 25121ebb-922b-719d-e063-6394a90a23d3 2026-01-08 Warnings Exact identifier application number: M021 Crest Pro-health Gum Detoxify Deep Clean STANNOUS FLUORIDE The Procter & Gamble Manufacturing Company f498b727-c38c-1d67-e053-2995a90a0f11 2026-01-08 Warnings Exact identifier application number: M021 DG health Sensitive Maximum Strength POTASSIUM NITRATE, SODIUM FLUORIDE Dolgencorp, LLC 81cd5d37-3751-625f-e053-2a91aa0a6dfd 2026-01-08 Warnings Exact identifier application number: M021 Crest 3D White Advanced Glamorous White SODIUM FLUORIDE The Procter & Gamble Manufacturing Company f5b18988-68c7-40f9-e053-2995a90a22bc 2026-01-08 Warnings Exact identifier application number: M021 CVS Restore and Defend Sensitive Whitening STANNOUS FLUORIDE CVS Pharmacy 81b72da2-7f41-74ca-e053-2a91aa0a9646 2026-01-08 Warnings Exact identifier application number: M021 Gum and Enamel Repair STANNOUS FLUORIDE CVS ccad05d4-7f05-bebd-e053-2a95a90aa52c 2026-01-08 Warnings Exact identifier application number: M021 CVS Pharmacy Pro Defense FLUORIDE CVS Pharmacy 445ec57e-dc3c-49a0-8ca9-4806fcdc0303 2026-01-08 Warnings Exact identifier application number: M021 Gum Detoxify STANNOUS FLUORIDE Walmart ad3f645d-aaf9-2800-e053-2a95a90ab62f 2026-01-08 Warnings Exact identifier application number: M021 CVS Complete Protection STANNOUS FLOURIDE CVS b681b5e4-a0e1-8d0f-e053-2a95a90aa672 2026-01-06 Warnings Exact identifier application number: M021 Complete Protection STANNOUS FLUORIDE Target 03708e08-0189-b83d-e063-6394a90a50e6 2026-01-06 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash 12oz Star Wars Saber Strike Strawberry SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 4998c0e6-1de3-11cd-e063-6294a90acb6f 2026-01-01 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 10237-677-12 10237067712 2 TUBE in 1 CARTON (10237-677-12) / 170 g in 1 TUBE 2 tube 2024-05-01 No No Current 10237-677-43 10237067743 1 TUBE in 1 CARTON (10237-677-43) / 121.9 g in 1 TUBE 1 tube 2024-01-01 No No Current