FDA.reportPublic FDA data

Colgate Anticavity

Product NDC
69491-033
Requested package NDC
69491-033-01
11-digit product format
694910033
Labeler code
69491
Product ID
69491-033_f114a573-ef41-639c-e053-2a95a90a1021
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE
Route
DENTAL
Labeler
Buzz Export Services Pty., Ltd.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-10-15
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
8 mg/g
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69491-03369491-033-01IInactivated by FDA2026-09-14

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-07-30Colgate Anticavity Toothpaste
2024-01-30Colgate Anticavity Toothpaste
2023-01-10Colgate Anticavity Toothpaste
2022-01-28Colgate Anticavity Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69491-033-01Colgate Anticavity10 g in 1 TUBEPASTE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69491-033MURCHISON HUME DENTAL KIT (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]3Legacy NDC20230111_b1a442e1-86cf-cba6-e053-2995a90a593a.zip
69491-033COLGATE ANTICAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE [BUZZ EXPORT SERVICES PTY., LTD.]2Legacy NDC, 1 package rows20230111_b1a41464-e7d7-640c-e053-2995a90a3f95.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Murchison Hume Dental KitSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.b1a442e1-86cf-cba6-e053-2995a90a593a2023-12-20WarningsExact identifier
ndc (package): 69491-033-01
ndc11 (package): 69491003301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNb1a442e1-86cf-cba6-e053-2995a90a593a4
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDb1a442e1-86cf-cba6-e053-2995a90a593a4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYb1a442e1-86cf-cba6-e053-2995a90a593a4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYb1a442e1-86cf-cba6-e053-2995a90a593a4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYb1a442e1-86cf-cba6-e053-2995a90a593a4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYb1a442e1-86cf-cba6-e053-2995a90a593a4
545626sodium monofluorophosphate 0.76 % ToothpastePSNb1a41464-e7d7-640c-e053-2995a90a3f952
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDb1a41464-e7d7-640c-e053-2995a90a3f952
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYb1a41464-e7d7-640c-e053-2995a90a3f952
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYb1a41464-e7d7-640c-e053-2995a90a3f952
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYb1a41464-e7d7-640c-e053-2995a90a3f952
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYb1a41464-e7d7-640c-e053-2995a90a3f952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69491-033-016949100330110 g in 1 TUBE (69491-033-01) 10 g2020-10-150000-00-00NoNoCurrent