ASTONEA -SODIUM FLUORIDE

Product NDC: 77338-091
Requested package NDC: 77338-091-38
11-digit product format: 773380091
Labeler code: 77338
Product ID: 77338-091_ef052828-db6d-d7a8-e053-2995a90a9031
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Floride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: ASTONEA LABS PRIVATE LIMITED
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-01-15
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 g/100g
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	77338-091	77338-091-38	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 · 3 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	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-091	77338-091-38	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-091	77338-091-38	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-091	77338-091-38	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
77338-091-38	2024-06-25	C162847	48780-1	1030e365-315d-111a-e063-dadaa90a10e2	astonea -sodium fluoride
77338-091-38	2024-01-30	C162847	48780-1	1030e365-315d-111a-e063-dadaa90a10e2	astonea -sodium fluoride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-091-38	ASTONEA -SODIUM FLUORIDE	43 g in 1 TUBE	PASTE, DENTIFRICE	43		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-091	ASTONEA -SODIUM FLUORIDE (SODIUM FLORIDE) PASTE, DENTIFRICE [ASTONEA LABS PRIVATE LIMITED]	3	Legacy NDC, 1 package rows	20240627_e69bc270-e909-1139-e053-2995a90a039b.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	e69bc270-e909-1139-e053-2995a90a039b	3
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	e69bc270-e909-1139-e053-2995a90a039b	3
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	e69bc270-e909-1139-e053-2995a90a039b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77338-091-38	77338009138	43 g in 1 TUBE (77338-091-38)	43 g	2015-01-15	0000-00-00	No	No	Current