simethicone 80 mg

Generic: simethicone

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

Drug Facts

Product Profile

Brand Name simethicone 80 mg
Generic Name simethicone
Labeler proficient rx lp
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dimethicone 80 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-043
Product ID 82804-043_c27c3d6a-64ca-47d4-bba6-a0c5288e755b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2018-04-24

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804043
Hyphenated Format 82804-043

Supplemental Identifiers

RxCUI
314216
UPC
0382804043309
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 80 mg (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
  • 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-30)
  • 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-60)
  • 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-90)
source: ndc

Packages (3)

82804-043-30 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-30) 82804-043-60 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-60) 82804-043-90 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-90)

Ingredients (1)

dimethicone (80 mg/1)

Linked Drug Pages (1)

Simethicone 80 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c27c3d6a-64ca-47d4-bba6-a0c5288e755b", "openfda": {"nui": ["N0000010282"], "upc": ["0382804043309"], "unii": ["92RU3N3Y1O"], "rxcui": ["314216"], "spl_set_id": ["a5e523b3-475e-4d28-a89c-c4325c59c939"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-30)", "package_ndc": "82804-043-30", "marketing_start_date": "20231116"}, {"sample": false, "description": "60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-60)", "package_ndc": "82804-043-60", "marketing_start_date": "20231116"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-90)", "package_ndc": "82804-043-90", "marketing_start_date": "20231116"}], "brand_name": "Simethicone 80 mg", "product_id": "82804-043_c27c3d6a-64ca-47d4-bba6-a0c5288e755b", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "82804-043", "generic_name": "Simethicone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Simethicone 80 mg", "active_ingredients": [{"name": "DIMETHICONE", "strength": "80 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180424", "listing_expiration_date": "20261231"}