NDC 0295-1237

Little Remedies Gas Relief Drops

Simthicone

Little Remedies Gas Relief Drops is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Denison Pharmaceuticals, Inc.. The primary component is Dimethicone.

• Product ID: 0295-1237_68524ce0-ca5f-48ef-860a-894ac02c4d29
• NDC: 0295-1237
• Product Type: Human Otc Drug
• Proprietary Name: Little Remedies Gas Relief Drops
• Generic Name: Simthicone
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2017-01-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part332
• Labeler Name: Denison Pharmaceuticals, Inc.
• Substance Name: DIMETHICONE
• Active Ingredient Strength: 20 mg/.3mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0295-1237-05

1 BOTTLE, DROPPER in 1 CARTON (0295-1237-05) > 30 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2017-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0295-1237-05 [00295123705]

Little Remedies Gas Relief Drops LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part332
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-01-01

NDC 0295-1237-02 [00295123702]

Little Remedies Gas Relief Drops LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part332
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-01-01

Drug Details

Active Ingredients

Ingredient	Strength
DIMETHICONE	20 mg/.3mL

OpenFDA Data

• SPL SET ID: b4318267-59f8-4b4b-ae80-c578f8b1fe80
• Manufacturer:
  • Denison Pharmaceuticals, Inc.
• UNII:
  • 92RU3N3Y1O
• RxNorm Concept Unique ID - RxCUI:
  • 198857

NDC Crossover Matching brand name "Little Remedies Gas Relief Drops" or generic name "Simthicone"

NDC	Brand Name	Generic Name
0295-1237	Little Remedies	simthicone
63029-103	Little Remedies	simthicone