infant gas relief

Generic: simethicone

Labeler: amerisourcebergen drug corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name infant gas relief
Generic Name simethicone
Labeler amerisourcebergen drug corporation
Dosage Form SUSPENSION/ DROPS
Routes
ORAL
Active Ingredients

dimethicone 20 mg/.3mL

Manufacturer
AMERISOURCEBERGEN DRUG CORPORATION

Identifiers & Regulatory

Product NDC 46122-547
Product ID 46122-547_00c51ee1-d7ea-17f1-e063-6394a90ac336
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2018-06-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46122547
Hyphenated Format 46122-547

Supplemental Identifiers

RxCUI
198857
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 infant 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 (46122-547-03) / 30 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

46122-547-03 1 BOTTLE, DROPPER in 1 CARTON (46122-547-03) / 30 mL in 1 BOTTLE, DROPPER

Ingredients (1)

dimethicone (20 mg/.3mL)

Linked Drug Pages (1)

INFANT GAS RELIEF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00c51ee1-d7ea-17f1-e063-6394a90ac336", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["198857"], "spl_set_id": ["7d3c3cc6-b0a2-620d-e053-2a91aa0a159b"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["AMERISOURCEBERGEN DRUG CORPORATION"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (46122-547-03)  / 30 mL in 1 BOTTLE, DROPPER", "package_ndc": "46122-547-03", "marketing_start_date": "20181116"}], "brand_name": "INFANT GAS RELIEF", "product_id": "46122-547_00c51ee1-d7ea-17f1-e063-6394a90ac336", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "46122-547", "generic_name": "Simethicone", "labeler_name": "AMERISOURCEBERGEN DRUG CORPORATION", "product_type": "HUMAN OTC DRUG", "brand_name_base": "INFANT GAS RELIEF", "active_ingredients": [{"name": "DIMETHICONE", "strength": "20 mg/.3mL"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180601", "listing_expiration_date": "20261231"}