gas relief

Generic: simethicone

Labeler: guardian drug company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gas relief
Generic Name simethicone
Labeler guardian drug company
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dimethicone 80 mg/1

Manufacturer
Guardian Drug Company

Identifiers & Regulatory

Product NDC 53041-103
Product ID 53041-103_a5c7c175-1fb7-4b4b-9ba1-b1df1251305c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2025-02-06

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53041103
Hyphenated Format 53041-103

Supplemental Identifiers

RxCUI
314216
UPC
0053041103162
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 gas relief (source: ndc)
Generic Name simethicone (source: ndc)
Application Number M002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (53041-103-16)
source: ndc

Packages (1)

53041-103-16 100 TABLET, CHEWABLE in 1 BOTTLE (53041-103-16)

Ingredients (1)

dimethicone (80 mg/1)

Linked Drug Pages (1)

Gas relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a5c7c175-1fb7-4b4b-9ba1-b1df1251305c", "openfda": {"nui": ["N0000010282"], "upc": ["0053041103162"], "unii": ["92RU3N3Y1O"], "rxcui": ["314216"], "spl_set_id": ["a5c7c175-1fb7-4b4b-9ba1-b1df1251305c"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (53041-103-16)", "package_ndc": "53041-103-16", "marketing_start_date": "20250206"}], "brand_name": "Gas relief", "product_id": "53041-103_a5c7c175-1fb7-4b4b-9ba1-b1df1251305c", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "53041-103", "generic_name": "Simethicone", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gas relief", "active_ingredients": [{"name": "DIMETHICONE", "strength": "80 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250206", "listing_expiration_date": "20261231"}