simethicone 125 mg

Generic: simethicone

Labeler: proficient rx lp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone 125 mg
Generic Name simethicone
Labeler proficient rx lp
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dimethicone 125 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-152
Product ID 82804-152_078ef54e-96b2-4e2f-bebc-9b9bcda1f90a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2018-04-25

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804152
Hyphenated Format 82804-152

Supplemental Identifiers

RxCUI
314221
UPC
0382804152094
UNII
92RU3N3Y1O
NUI
N0000010282

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 125 mg (source: ndc)
Generic Name simethicone (source: ndc)
Application Number M002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-152-09)
source: ndc

Packages (1)

82804-152-09 9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-152-09)

Ingredients (1)

dimethicone (125 mg/1)

Linked Drug Pages (1)

Simethicone 125 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "078ef54e-96b2-4e2f-bebc-9b9bcda1f90a", "openfda": {"nui": ["N0000010282"], "upc": ["0382804152094"], "unii": ["92RU3N3Y1O"], "rxcui": ["314221"], "spl_set_id": ["078ef54e-96b2-4e2f-bebc-9b9bcda1f90a"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-152-09)", "package_ndc": "82804-152-09", "marketing_start_date": "20240925"}], "brand_name": "Simethicone 125 mg", "product_id": "82804-152_078ef54e-96b2-4e2f-bebc-9b9bcda1f90a", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "82804-152", "generic_name": "Simethicone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Simethicone 125 mg", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180425", "listing_expiration_date": "20261231"}