FDA.reportPublic FDA data

Crest Gum and Enamel Repair

Product NDC
37000-506
Requested package NDC
37000-506-41
11-digit product format
370000506
Labeler code
37000
Product ID
37000-506_d60a5c8c-77ab-97e3-e053-2995a90a763a
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-04-01
Marketing end
0000-00-00
Substance
STANNOUS FLUORIDE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage37000-50637000-506-41DDiscontinued by firm2026-10-15

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37000-50637000-506-41DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37000-50637000-506-41IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37000-50637000-506-41IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-506-032024-12-17Crest® Gum & Enamel Repair Intensive Clean
37000-506-282024-12-17Crest® Gum & Enamel Repair Intensive Clean
37000-506-412024-12-17Crest® Gum & Enamel Repair Intensive Clean
37000-506-032024-07-30Crest® Gum & Enamel Repair Intensive Clean
37000-506-282024-07-30Crest® Gum & Enamel Repair Intensive Clean
37000-506-412024-07-30Crest® Gum & Enamel Repair Intensive Clean
37000-506-032024-01-30Crest® Gum & Enamel Repair Intensive Clean
37000-506-282024-01-30Crest® Gum & Enamel Repair Intensive Clean
37000-506-412024-01-30Crest® Gum & Enamel Repair Intensive Clean

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-506CREST GUM AND ENAMEL REPAIR ADVANCED WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Legacy NDC20250116_6819d70c-4541-5064-e053-2991aa0a7893.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-506-41370000506411 TUBE in 1 CARTON (37000-506-41) > 116 g in 1 TUBE1 tube2018-04-010000-00-00NoNoCurrent