NDC 55918-002

Phocal pHn

Sodium Fluoride

Phocal pHn is a Topical Disc in the Human Prescription Drug category. It is labeled and distributed by Phocal Therapy Inc. The primary component is Sodium Fluoride.

• Product ID: 55918-002_53bd9eed-c82e-4efc-a073-8f9e8fc166be
• NDC: 55918-002
• Product Type: Human Prescription Drug
• Proprietary Name: Phocal pHn
• Generic Name: Sodium Fluoride
• Dosage Form: Disc
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-01-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Phocal Therapy Inc
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 0 mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 55918-002-20

2 BLISTER PACK in 1 BOX (55918-002-20) > 10 DISC in 1 BLISTER PACK

• Marketing Start Date: 2013-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55918-002-20 [55918000220]

Phocal pHn DISC

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	.055 mg/1

OpenFDA Data

• SPL SET ID: 46a34092-7369-4586-9d5a-5f182d551a5f
• Manufacturer:
  • Phocal Therapy Inc
• UNII:
  • 8ZYQ1474W7

NDC Crossover Matching brand name "Phocal pHn" or generic name "Sodium Fluoride"

NDC	Brand Name	Generic Name
55918-002	Phocal pHn	Phocal pHn
0135-0234	AQUAFRESH	sodium fluoride
0126-0021	Colgate	SODIUM FLUORIDE
0126-0034	Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride	SODIUM FLUORIDE
0126-0032	Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride	SODIUM FLUORIDE
0041-1421	Oral-B	Sodium Fluoride
0126-0131	Phos-Flur	Sodium Fluoride
0126-0135	Phos-Flur Ortho Defense	SODIUM FLUORIDE
0126-0138	Phos-Flur Ortho Defense	SODIUM FLUORIDE
0126-0139	Phos-Flur Ortho Defense	SODIUM FLUORIDE
0126-0074	PrevidDent 5000 Booster Plus Spearmint	Sodium Fluoride
0126-0016	PreviDent	Sodium fluoride
0126-0075	PreviDent	Sodium fluoride
0126-0076	PreviDent	Sodium fluoride
0126-0179	PreviDent	Sodium Fluoride
0126-0286	PreviDent	Sodium Fluoride
0126-0287	PreviDent	Sodium Fluoride
0126-0072	PreviDent 5000 Booster Plus Fruitastic	Sodium Fluoride
0126-0033	PreviDent Alcohol Free	Sodium Fluoride
0126-0088	PreviDent Fresh Mint	Sodium Fluoride
0126-0289	PreviDent OrthoDefense	SODIUM FLUORIDE
0126-0288	PreviDent Very Berry	Sodium Fluoride