Home NDC 71927-102 Orazen
Product NDC 71927-102
11-digit product format 719270102
Labeler code 71927
Product ID 71927-102_536042f4-24c3-0778-e063-6294a90aaf42
Type HUMAN OTC DRUG
Nonproprietary name SODIUM MONOFLUOROPHOSPHATE
Dosage form PASTE
Route DENTAL
Labeler Orazen Inc
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-01
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength .1 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71927-102-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71927-102-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71927-102-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71927-102-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71927-102-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71927-102-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71927-102-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71927-102-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71927-102-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 Orazen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE .1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71927-102-01 Orazen 28 g in 1 TUBE PASTE 28 2 71927-102-01 Orazen 1 in 1 POUCH PASTE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71927-102 ORAZEN (SODIUM MONOFLUOROPHOSPHATE) PASTE [ORAZEN INC] 2 Current NDC, 2 package rows 20230814_fa5b6bd8-443f-79e7-e053-6394a90a5513.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 17 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join WALMART SALINE SALINE NASAL (SODIUM CHLORIDE) WALMART STORES INC 06906744-49a5-4bab-8539-af2d235df9e8 2025-10-28 Warnings Exact identifier application number: M022 Saline NASAL PUBLIX SUPER MARKETS, INC 19841567-9511-43d6-ba4e-d1e1bd3481a4 2025-10-28 Warnings Exact identifier application number: M022 PUBLIX Sore Throat Fast Relief Oral Anesthetic PHENOL PUBLIX SUPER MARKETS, INC 89291f12-bbc3-4472-8ad3-a34485af72c9 2025-10-28 Warnings Exact identifier application number: M022 PUBLIX Sore Throat Menthol Flavor PHENOL PUBLIX SUPER MARKETS, INC 9296c49e-557c-43ed-9527-fcba5093a8dc 2025-10-28 Warnings Exact identifier application number: M022 WinCo Foods Maximum Strength Oral Analgesic BENZOCAINE WinCo Foods, LLC c22a7726-8c3f-41bf-b852-8456b2be6f93 2025-10-28 Warnings Exact identifier application number: M022 Rugby Cherry Flavor PHENOL RUGBY LABORATORIES 3d668c78-8130-45d4-bcb7-dddcb2fbe7a3 2025-10-25 Warnings Exact identifier application number: M022 LolliCaine Bubble Gum BENZOCAINE Centrix, Inc. 56ae3a84-6bca-4906-a03d-9d755e1fba3b 2025-10-24 Warnings Exact identifier application number: M022 Diabetic Tussin Sore Throat Cherry PHENOL MEDTECH PRODUCTS INC ab351229-5771-4c6c-92a8-721cc41c002f 2025-10-23 Warnings Exact identifier application number: M022 Chloraseptic Total Sore Throat and Cough, Sugar Free MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE Prestige Brands Holdings, Inc. 34e4234c-ed61-4795-99fe-d281cdb0af88 2025-10-23 Warnings Exact identifier application number: M022 Chloraseptic Total Sore Throat and Cough MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE Prestige Brands Holdings, Inc. 6b1a50d0-be54-4fcb-b5e2-b47abf3555c0 2025-10-23 Warnings Exact identifier application number: M022 Chloraseptic Childrens Sore Throat Cherry PHENOL Prestige Brands Holdings, Inc. 38ff6922-1abe-4fa9-a74e-ede604f707b5 2025-10-23 Warnings Exact identifier application number: M022 Boka Sensitive POTASSIUM NITRATE Karaka LLC 40be9fab-53db-c67a-e063-6394a90a48cb 2025-10-23 Warnings Exact identifier application number: M022 Canker Care Plus MENTHOL, UNSPECIFIED FORM Quantum, Inc. 1ec960db-52d5-4d99-a7f7-a2e538d28724 2025-10-20 Warnings Exact identifier application number: M022 meijer Sensitive EXTRA WHITENING POTASSIUM NITRATE, SODIUM FLUORIDE Meijer, Inc. bbcffb88-0bd4-4883-bb83-0b7a1428ad12 2025-10-20 Warnings Exact identifier application number: M022 Quality Choice Maximum Strength Oral Pain Relieving BENZOCAINE Chain Drug Marketing Association Inc dbde8e7f-85d8-4083-b01a-3a7e410a7747 2025-10-17 Warnings Exact identifier application number: M022 Quality Choice BENZOCAINE Chain Drug Marketing Association, Inc. 24c3c4a3-bd76-198d-e063-6394a90ad45a 2025-10-16 Warnings Exact identifier application number: M022 Sore Throat Relief Cherry Flavor PHENOL Cardinal Health b84203bd-23e9-427d-83d8-f4c88266e23c 2025-10-14 Warnings Exact identifier application number: M022 Finafta BENZOCAINE, GLYCERIN Efficient Laboratories Inc. 03368603-3e11-c2fa-e063-6294a90a04ea 2025-10-14 Warnings Exact identifier application number: M022 Sensodyne Pronamel Clinical Enamel Strength Whitening Action POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC e8a62f24-1db6-45fb-b6e1-5e57103f82bc 2025-10-14 Warnings Exact identifier application number: M022 evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT POTASSIUM NITRATE, SODIUM FLUORIDE Ashtel Studios, Inc. bc74d2a6-fe34-44cf-b015-70ed4d47c933 2025-10-13 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71927-102-01 71927010201 1 TUBE in 1 POUCH (71927-102-01) / 28 g in 1 TUBE 1 tube 2023-04-01 No No Current