Sodium Fluoride 5000 Plus

Product NDC
63629-1151
11-digit product format
636291151
Labeler code
63629
Product ID
63629-1151_38e30708-ba29-4652-bd85-490d31901968
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
CREAM
Route
DENTAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-05-28
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
5 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1151DDiscontinued by firm2026-08-11
excluded packagepackage63629-115163629-1151-1DDiscontinued by firm2026-08-11

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1151-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1151-1f5e01cc5f278…a2eaf40c39c3…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1151-1GM - Gram63629-115100e000c6-c24d-4499-99b7-63c87a140b3512021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1151SODIUM FLUORIDE 5000 PLUS (SODIUM FLUORIDE) CREAM [BRYANT RANCH PREPACK]100Legacy NDC20201017_c6aebfbe-9edd-4509-b5c0-4121a756bb1f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1151-16362911510151 g in 1 TUBE (63629-1151-1) 51 g2020-10-060000-00-00NoNoCurrent