simethicone infant gas relief drops

Generic: simethicone

Labeler: aarna usa inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone infant gas relief drops
Generic Name simethicone
Labeler aarna usa inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

dimethicone 20 mg/.3mL

Manufacturer
AARNA USA Inc.

Identifiers & Regulatory

Product NDC 82568-0017
Product ID 82568-0017_3b14f103-c7f9-f905-e063-6294a90a0e2c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2025-02-20

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 825680017
Hyphenated Format 82568-0017

Supplemental Identifiers

RxCUI
198857
UPC
0382568001737
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 simethicone infant gas relief drops (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 in 1 PACKAGE (82568-0017-3) / 30 mL in 1 BOTTLE
  • 118 mL in 1 BOTTLE (82568-0017-4)
source: ndc

Packages (2)

82568-0017-3 1 BOTTLE in 1 PACKAGE (82568-0017-3) / 30 mL in 1 BOTTLE 82568-0017-4 118 mL in 1 BOTTLE (82568-0017-4)

Ingredients (1)

dimethicone (20 mg/.3mL)

Linked Drug Pages (1)

SIMETHICONE INFANT Gas Relief Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b14f103-c7f9-f905-e063-6294a90a0e2c", "openfda": {"nui": ["N0000010282"], "upc": ["0382568001737"], "unii": ["92RU3N3Y1O"], "rxcui": ["198857"], "spl_set_id": ["9b0fde90-35ae-498e-99cc-d120f1a87182"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["AARNA USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 PACKAGE (82568-0017-3)  / 30 mL in 1 BOTTLE", "package_ndc": "82568-0017-3", "marketing_start_date": "20250220"}, {"sample": false, "description": "118 mL in 1 BOTTLE (82568-0017-4)", "package_ndc": "82568-0017-4", "marketing_start_date": "20250220"}], "brand_name": "SIMETHICONE INFANT Gas Relief Drops", "product_id": "82568-0017_3b14f103-c7f9-f905-e063-6294a90a0e2c", "dosage_form": "SUSPENSION", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "82568-0017", "generic_name": "Simethicone", "labeler_name": "AARNA USA Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SIMETHICONE INFANT", "brand_name_suffix": "Gas Relief Drops", "active_ingredients": [{"name": "DIMETHICONE", "strength": "20 mg/.3mL"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250220", "listing_expiration_date": "20261231"}