PCXX RASPBERRY APF G

Product NDC: 62007-809
Requested package NDC: 62007-809-16
11-digit product format: 620070809
Labeler code: 62007
Product ID: 62007-809_ba3dccee-b4d7-a919-e053-2a95a90a5a2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: GEL
Route: DENTAL; TOPICAL
Labeler: Ross Healthcare Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2019-02-04
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 27 mg/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	62007-809	62007-809-16	D	Discontinued by firm		2026-09-14

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
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62007-809	62007-809-16	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62007-809	62007-809-16	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
62007-809-16	2021-01-31	C162847	48780-1	ba0f9c33-1ae7-a910-e053-dadaa90a0b85	PCXX RASPBERRY APF GEL
62007-809-16	2021-01-29	C162847	48780-1	ba0f9c33-1ae7-a910-e053-dadaa90a0b85	PCXX RASPBERRY APF GEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62007-809	PCXX RASPBERRY APF G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]	6	Legacy NDC	20250201_8281515f-08ab-509c-e053-2a91aa0abae3.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
62007-809-16	62007080916	473 mL in 1 BOTTLE, PLASTIC (62007-809-16)	473 ml	2019-02-04	0000-00-00	No	No	Current