Home NDC 72164-101 4 Pack
Product NDC 72164-101
11-digit product format 721640101
Labeler code 72164
Product ID 72164-101_ebe7dfa2-50fa-1d2d-e053-2995a90abd14
Type HUMAN OTC DRUG
Nonproprietary name POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form KIT
Labeler Smiletwice, Inc.
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2018-09-14
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 72164-101-04 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 72164-101-04 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 72164-101-04 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 72164-101-04 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 72164-101-04 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 72164-101-04 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 72164-101-04 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 72164-101-04 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 72164-101-04 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72164-000-01 4 Pack 96 g in 1 TUBE PASTE 192 g 50 mg in 1g 6 72164-001-01 4 Pack 96 g in 1 TUBE PASTE 192 g 50 mg in 1g 6 72164-101-04 4 Pack 1 in 1 KIT KIT 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72164-101 4 PACK (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.] 6 Legacy NDC, 3 package rows 20231221_c3707c03-3761-4901-89c4-11d214c9287d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72164-000-01 72164000001 96 g in 1 TUBE 96 g Historical 72164-001-01 72164000101 96 g in 1 TUBE 96 g Historical 72164-101-04 72164010104 1 KIT in 1 KIT (72164-101-04) * 2 TUBE in 1 BOX > 96 g in 1 TUBE (72164-000-01) * 2 TUBE in 1 BOX > 96 g in 1 TUBE (72164-001-01) 1 kit 2018-09-14 0000-00-00 No No Current