PCXX GRAPE APF G

Product NDC: 62007-812
11-digit product format: 620070812
Labeler code: 62007
Product ID: 62007-812_42f4960d-f29a-d25e-e063-6394a90aa243
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
Substance: SODIUM FLUORIDE
Active strength: 27.2 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: PCXX GRAPE APF G
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	27.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1535362	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82872a07-04b7-5263-e053-2a91aa0aa2c2	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2021-01-31	PCXX GRAPE APF GEL
2021-01-31	PCXX GRAPE APF GEL
2021-01-29	PCXX GRAPE APF GEL
2021-01-29	PCXX GRAPE APF GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62007-812-16	PCXX GRAPE APF G	473 mL in 1 BOTTLE, PLASTIC	GEL	473		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62007-812	PCXX GRAPE APF G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]	5	Current NDC, Legacy NDC, 1 package rows	20250201_82872a07-04b7-5263-e053-2a91aa0aa2c2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PCXX GRAPE APF G	SODIUM FLUORIDE	Ross Healthcare Inc.	82872a07-04b7-5263-e053-2a91aa0aa2c2	2025-11-06		Exact identifier ndc (product): 62007-812

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
1535362	sodium fluoride 2.72 % Oral Gel	PSN	82872a07-04b7-5263-e053-2a91aa0aa2c2	6
1535362	sodium fluoride 0.0272 MG/MG Oral Gel	SCD	82872a07-04b7-5263-e053-2a91aa0aa2c2	6
1535362	sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral Gel	SY	82872a07-04b7-5263-e053-2a91aa0aa2c2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62007-812-16	62007081216	473 mL in 1 BOTTLE, PLASTIC (62007-812-16)	473 ml	2019-02-04	0000-00-00	No	No	Current