mylicon infants gas relief original

Generic: simethicone

Labeler: infirst healthcare
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name mylicon infants gas relief original
Generic Name simethicone
Labeler infirst healthcare
Dosage Form EMULSION
Routes
ORAL
Active Ingredients

dimethicone 20 mg/.3mL

Manufacturer
Infirst Healthcare

Identifiers & Regulatory

Product NDC 62372-630
Product ID 62372-630_0bb18b4c-fbe3-8d2a-e063-6394a90a4f5c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2015-03-31

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62372630
Hyphenated Format 62372-630

Supplemental Identifiers

RxCUI
198857 809376
UNII
92RU3N3Y1O
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mylicon infants gas relief original (source: ndc)
Generic Name simethicone (source: ndc)
Application Number M002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/.3mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (62372-630-15) / 15 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (62372-630-30) / 30 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

62372-630-15 1 BOTTLE, DROPPER in 1 CARTON (62372-630-15) / 15 mL in 1 BOTTLE, DROPPER 62372-630-30 1 BOTTLE, DROPPER in 1 CARTON (62372-630-30) / 30 mL in 1 BOTTLE, DROPPER

Ingredients (1)

dimethicone (20 mg/.3mL)

Linked Drug Pages (1)

Mylicon Infants Gas Relief Original ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0bb18b4c-fbe3-8d2a-e063-6394a90a4f5c", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["198857", "809376"], "spl_set_id": ["395be942-d883-4bcb-8811-6fe1521d5a92"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Infirst Healthcare"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (62372-630-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "62372-630-15", "marketing_start_date": "20150331"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (62372-630-30)  / 30 mL in 1 BOTTLE, DROPPER", "package_ndc": "62372-630-30", "marketing_start_date": "20150331"}], "brand_name": "Mylicon Infants Gas Relief Original", "product_id": "62372-630_0bb18b4c-fbe3-8d2a-e063-6394a90a4f5c", "dosage_form": "EMULSION", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "62372-630", "generic_name": "Simethicone", "labeler_name": "Infirst Healthcare", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mylicon Infants Gas Relief Original", "active_ingredients": [{"name": "DIMETHICONE", "strength": "20 mg/.3mL"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150331", "listing_expiration_date": "20261231"}