# Infants Simethicone Drops

NDC: 0121-1094
Generic name: Infants Simethicone Drops
Labeler / Manufacturer: PAI Holdings, LLC dba PAI Pharma
Product type: HUMAN OTC DRUG
Marketing category: OTC monograph drug
Dosage form: LIQUID
Routes: ORAL
Marketing started: 20260608

FDA application: M002

## Active ingredients

- DIMETHICONE: 20 mg/.3mL

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0121-1094"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0121-1094
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=235f458e-c275-4bc1-9c0f-e007c4040649