FDA.reportPublic FDA data

Crest Gum and Enamel Repair

Product NDC
37000-505
11-digit product format
370000505
Labeler code
37000
Product ID
37000-505_c3f4115f-10d0-4377-e053-2995a90aea19
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
2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37000-505DDiscontinued by firm2026-10-12
excluded packagepackage37000-50537000-505-28DDiscontinued by firm2026-10-12
excluded packagepackage37000-50537000-505-41DDiscontinued by firm2026-10-12
excluded packagepackage37000-50537000-505-85DDiscontinued by firm2026-10-12

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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage37000-505-85
excluded packagepackage37000-505-41
excluded packagepackage37000-505-28

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
37000-505-282023-03-30Crest® Gum & Enamel Repair Intensive Clean
37000-505-412023-03-30Crest® Gum & Enamel Repair Intensive Clean
37000-505-852023-03-30Crest® Gum & Enamel Repair Intensive Clean
37000-505-282023-01-30Crest® Gum & Enamel Repair Intensive Clean
37000-505-412023-01-30Crest® Gum & Enamel Repair Intensive Clean
37000-505-852023-01-30Crest® Gum & Enamel Repair Intensive Clean

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-505CREST GUM AND ENAMEL REPAIR INTENSIVE CLEAN (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Legacy NDC20250110_68195b9a-b841-8d18-e053-2a91aa0a370c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-505-28370000505281 TUBE in 1 CARTON (37000-505-28) > 79 g in 1 TUBE1 tube2018-04-010000-00-00NoNoCurrent
37000-505-41370000505411 TUBE in 1 CARTON (37000-505-41) > 116 g in 1 TUBE1 tube2018-04-010000-00-00NoNoCurrent
37000-505-85370000505851 TUBE in 1 CARTON (37000-505-85) > 24 g in 1 TUBE1 tube2018-04-010000-00-00NoNoCurrent