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 19 of 51 · 1,013 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash SODIUM FLUORIDE Kenvue Brands LLC 49d1932f-a85c-7b8f-e063-6394a90a6aca 2026-02-02 Warnings Exact identifier application number: M021 Listerine Total Care Mild Alcohol Free Anticavity Fluoride Mouthwash SODIUM FLUORIDE Kenvue Brands LLC 49d4f96f-e61f-e6e6-e063-6294a90ab0a0 2026-02-02 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash Toy Story Wild West Watermelon SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 49d69901-0b07-b07d-e063-6394a90a3c34 2026-02-02 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash Frozen Blizzard Berry SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 49d6c1c9-cd21-cac6-e063-6294a90a81d6 2026-02-02 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash Disney Princesses Grand Grape SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 49d6f926-da4e-26df-e063-6294a90a1c0c 2026-02-02 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker Punch SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 49d70b88-d57c-37cd-e063-6294a90a4a59 2026-02-02 Warnings Exact identifier application number: M021 Anticavity SODIUM FLUORIDE Rite Aid Corporation 54a8b884-969a-4a41-ac2a-bc1f1fe9f7fe 2026-02-02 Warnings, Adverse reactions Exact identifier application number: M021 Burts Bees Charcoal Peppermint SODIUM FLUORIDE Procter & Gamble Manufacturing Company a343853e-4968-2753-e053-2995a90ab152 2026-02-02 Warnings Exact identifier application number: M021 Burts Bees Complete Multi-Care SODIUM FLUORIDE Procter & Gamble Manufacturing Company 12615266-06e8-b891-e063-6394a90ad75d 2026-02-02 Warnings Exact identifier application number: M021 LIVFRESH GUM PROTECT STANNOUS FLUORIDE Livionex Inc. 1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f 2026-02-02 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash Disney Cars Chow Cherry SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 49d66ad5-cdae-52f4-e063-6294a90a8ee9 2026-02-01 Warnings Exact identifier application number: M021 Crest 3D White Deep Stain Remover Brilliant White SODIUM MONOFLUOROPHOSPHATE The Procter & Gamble Manufacturing Company 4e53a086-6cda-6460-e063-6394a90af1f3 2026-02-01 Exact identifier application number: M021 ACT Kids Berry Blast SODIUM FLUORIDE Chattem, Inc. 4f81ea98-5c74-4473-9764-3f11d627cdf1 2026-02-01 Warnings Exact identifier application number: M021 Anticavity Rinse SODIUM FLUORIDE Rite Aid Corporation c1a22692-b955-498a-a7c1-1cd7bfd54bda 2026-01-30 Warnings, Adverse reactions Exact identifier application number: M021 ARU GUM HEALTH STANNOUS FLUORIDE Ashtel Studios, Inc. d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd3 2026-01-30 Warnings Exact identifier application number: M021 Colgate Anticavity SODIUM MONOFLUOROPHOSPHATE FORMIA LIMITED b5eec445-d93a-4abb-a5e3-bfcde6fa2013 2026-01-28 Warnings Exact identifier application number: M021 Supersmile Original Mint SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 24fee793-57ed-87e9-e063-6394a90ab4ce 2026-01-28 Warnings Exact identifier application number: M021 Colgate 5g and Toothbrush Dental Kit SODIUM MONOFLUOROPHOSPHATE FORMIA LIMITED 0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13 2026-01-28 Warnings Exact identifier application number: M021 Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey Punch SODIUM FLUORIDE Ashtel Studios Inc. 023cb63c-52b4-4723-bff6-c25105a53f76 2026-01-28 Warnings Exact identifier application number: M021 Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike Strawberry SODIUM FLUORIDE Ashtel Studios, Inc. ef4ea4a3-c1ac-447f-a70b-e3a330928cfd 2026-01-27 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