Home NDC 55312-158 Western Family Sensitive Whitening Fluoride
Product NDC 55312-158
11-digit product format 553120158
Labeler code 55312
Product ID 55312-158_63096f4e-6f42-4006-9252-5b2330b6912f
Type HUMAN OTC DRUG
Nonproprietary name Potassium Nitrate and Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Western Family Food, Inc.
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2007-05-02
Marketing end 0000-00-00
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 5 mg/g; mg/g
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55312-158-09 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55312-158-09 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55312-158-09 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55312-158-09 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55312-158-09 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55312-158-09 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55312-158-09 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55312-158-09 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55312-158-09 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55312-158-09 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55312-158-09 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55312-158-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 55312-158-09 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 55312-158-09 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 55312-158-09 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 55312-158-09 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 55312-158-09 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 55312-158-09 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 55312-158-09 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 55312-158-09 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 55312-158-09 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 55312-158-09 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55312-158-09 Western Family Sensitive Whitening Fluoride 113 g in 1 TUBE PASTE, DENTIFRICE 113 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POTASSIUM NITRATE ACTIVE INGREDIENT RU45X2JN0Z WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 POTASSIUM CATION ACTIVE MOIETY 295O53K152 WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 SODIUM PHOSPHATE INACTIVE INGREDIENT SE337SVY37 WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55312-158 WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.] 1 Legacy NDC, 1 package rows 20110222_046dd282-fcd6-4fce-b636-5d6f576d6e72.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 55312-158-09 55312015809 113 g in 1 TUBE 113 g Historical