Home NDC 54473-188 Whitening
Product NDC 54473-188
11-digit product format 544730188
Labeler code 54473
Product ID 54473-188_9409ac74-864b-4c54-9a92-14adf0f70423
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE
Route TOPICAL
Labeler Melaleuca, Inc.
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-04-01
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 0 g/108g
NDC exclude flag E
Listing certified through 2018-12-31
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 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 54473-188-04 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 54473-188-04 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 54473-188-04 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 54473-188-04 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 54473-188-04 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 54473-188-04 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54473-188-04 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54473-188-04 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54473-188-04 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 54473-188-04 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 54473-188-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 54473-188-04 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 54473-188-04 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 54473-188-04 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 54473-188-04 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 54473-188-04 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 54473-188-04 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 54473-188-04 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 54473-188-04 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 54473-188-04 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 54473-188-04 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 54473-188-04 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 54473-188-04 WhiteningTooth Polish 108 g in 1 TUBE PASTE 108 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 MYRRH OIL INACTIVE INGREDIENT H74221J5J4 WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 PAPAIN INACTIVE INGREDIENT A236A06Y32 WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 POTASSIUM PYROPHOSPHATE INACTIVE INGREDIENT B9W4019H5G WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-188 WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.] 1 Legacy NDC, 1 package rows 20110216_d3270563-dd7e-474e-bae3-511efb430370.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 54473-188-04 54473018804 108 g in 1 TUBE 108 g Historical