Emmi-dent Kids

Product NDC: 63956-002
Requested package NDC: 63956-002-02
11-digit product format: 639560002
Labeler code: 63956
Product ID: 63956-002_3684f8bc-d7f9-4c96-8c9b-e50a55cfdcd1
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: EMAG AG
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-07-15
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 110 mg/75mL
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63956-002	63956-002-02	I	Inactivated by FDA		2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63956-002	63956-002-02	I	Inactivated by FDA		excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63956-002	63956-002-02	I	Inactivated by FDA		excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63956-002-02	2024-12-11	C162847	48780-1	1030e365-3d03-111a-e063-dadaa90a10e2	Emmi ® -dent Kids
63956-002-02	2024-07-30	C162847	48780-1	1030e365-3d03-111a-e063-dadaa90a10e2	Emmi ® -dent Kids
63956-002-02	2024-01-30	C162847	48780-1	1030e365-3d03-111a-e063-dadaa90a10e2	Emmi ® -dent Kids

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63956-002-02	Emmi-dent Kids	75 mL in 1 TUBE	PASTE, DENTIFRICE	75		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63956-002	EMMI-DENT KIDS (SODIUM FLUORIDE) PASTE, DENTIFRICE [EMAG AG]	4	Legacy NDC, 1 package rows	20241213_4accb6bc-c9f9-4af1-a766-4872d94d08b1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63956-002-02	63956000202	75 mL in 1 TUBE (63956-002-02)	75 ml	2019-07-15	0000-00-00	No	No	Current