PCXX CREME DE MENTHE NEUTRAL GL

Product NDC: 62007-820
Requested package NDC: 62007-820-16
11-digit product format: 620070820
Labeler code: 62007
Product ID: 62007-820_ba3dccee-b4d5-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: 2019-02-22
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 20 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	62007-820	62007-820-16	E	Excluded after deficient or non-compliant submission was not corrected		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 · 1 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	62007-820	62007-820-16	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
62007-820-16	2021-01-31	C162847	48780-1	ba0f9c33-571b-a910-e053-dadaa90a0b85	PCXX CREME DE MENTHE NEUTRAL GEL
62007-820-16	2021-01-29	C162847	48780-1	ba0f9c33-571b-a910-e053-dadaa90a0b85	PCXX CREME DE MENTHE NEUTRAL GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62007-820-16	PCXX CREME DE MENTHE NEUTRAL GL	473 mL in 1 BOTTLE, PLASTIC	GEL	473		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62007-820	PCXX CREME DE MENTHE NEUTRAL GL (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]	5	Legacy NDC, 1 package rows	20250201_8282caef-db9c-122b-e053-2a91aa0a8bdd.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
245593	sodium fluoride 2 % Dental Gel	PSN	8282caef-db9c-122b-e053-2a91aa0a8bdd	5
245593	sodium fluoride 0.02 MG/MG Oral Gel	SCD	8282caef-db9c-122b-e053-2a91aa0a8bdd	5
245593	sodium fluoride 2 % (fluoride ion 1.23 % ) Dental Gel	SY	8282caef-db9c-122b-e053-2a91aa0a8bdd	5
245593	sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental Gel	SY	8282caef-db9c-122b-e053-2a91aa0a8bdd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62007-820-16	62007082016	473 mL in 1 BOTTLE, PLASTIC (62007-820-16)	473 ml	2019-02-22	0000-00-00	No	No	Current