infants gas relief

Generic: simethicone

Labeler: topco associates, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name infants gas relief
Generic Name simethicone
Labeler topco associates, llc
Dosage Form SOLUTION/ DROPS
Routes
ORAL
Active Ingredients

dimethicone 20 mg/.3mL

Manufacturer
Topco Associates, LLC

Identifiers & Regulatory

Product NDC 36800-119
Product ID 36800-119_edbc1a70-0fe7-42c4-a835-140c9f6aaf4a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2013-03-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800119
Hyphenated Format 36800-119

Supplemental Identifiers

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 infants gas relief (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 (36800-119-09) / 30 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

36800-119-09 1 BOTTLE, DROPPER in 1 CARTON (36800-119-09) / 30 mL in 1 BOTTLE, DROPPER

Ingredients (1)

dimethicone (20 mg/.3mL)

Linked Drug Pages (1)

Infants Gas relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "edbc1a70-0fe7-42c4-a835-140c9f6aaf4a", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "spl_set_id": ["fd6a2537-8db2-492d-b045-6404df2fb9c3"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Topco Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (36800-119-09)  / 30 mL in 1 BOTTLE, DROPPER", "package_ndc": "36800-119-09", "marketing_start_date": "20130301"}], "brand_name": "Infants Gas relief", "product_id": "36800-119_edbc1a70-0fe7-42c4-a835-140c9f6aaf4a", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "36800-119", "generic_name": "Simethicone", "labeler_name": "Topco Associates, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Infants Gas relief", "active_ingredients": [{"name": "DIMETHICONE", "strength": "20 mg/.3mL"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130301", "listing_expiration_date": "20261231"}