NDC 61041-211

XEROSTOM

Sodium Fluoride

XEROSTOM is a Oral Mouthwash in the Human Otc Drug category. It is labeled and distributed by Bio Cosmetics. The primary component is Sodium Fluoride.

• Product ID: 61041-211_07ceb03e-9994-498c-a020-d7f17f9da10b
• NDC: 61041-211
• Product Type: Human Otc Drug
• Proprietary Name: XEROSTOM
• Generic Name: Sodium Fluoride
• Dosage Form: Mouthwash
• Route of Administration: ORAL
• Marketing Start Date: 2013-11-15
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part355
• Labeler Name: Bio Cosmetics
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 1 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 61041-211-09

1 BOTTLE in 1 CARTON (61041-211-09) > 250 mL in 1 BOTTLE

• Marketing Start Date: 2013-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61041-211-09 [61041021109]

XEROSTOM MOUTHWASH

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-11-15

NDC 61041-211-31 [61041021131]

XEROSTOM MOUTHWASH

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-02-06

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	.559 mg/mL

OpenFDA Data

• SPL SET ID: 28a1a9c9-9c9a-4e43-b12c-85ded19ed926
• Manufacturer:
  • Bio Cosmetics
• UNII:
  • 8ZYQ1474W7

NDC Crossover Matching brand name "XEROSTOM" or generic name "Sodium Fluoride"

NDC	Brand Name	Generic Name
61041-211	XEROSTOM	XEROSTOM
61041-212	XEROSTOM	XEROSTOM
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