simethicone

Generic: simethicone

Labeler: richmond pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone
Generic Name simethicone
Labeler richmond pharmaceuticals, inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dimethicone 80 mg/1

Manufacturer
Richmond Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 54738-518
Product ID 54738-518_5cc86981-732a-038f-e053-2991aa0a19d4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part332
Listing Expiration 2026-12-31
Marketing Start 2011-03-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54738518
Hyphenated Format 54738-518

Supplemental Identifiers

RxCUI
314216
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 (source: ndc)
Generic Name simethicone (source: ndc)
Application Number part332 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (54738-518-01)
source: ndc

Packages (1)

54738-518-01 100 TABLET, CHEWABLE in 1 BOTTLE (54738-518-01)

Ingredients (1)

dimethicone (80 mg/1)

Linked Drug Pages (1)

Simethicone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5cc86981-732a-038f-e053-2991aa0a19d4", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["314216"], "spl_set_id": ["f4be1c0d-01fc-4681-9068-905ed3184534"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Richmond Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (54738-518-01)", "package_ndc": "54738-518-01", "marketing_start_date": "20110301"}], "brand_name": "Simethicone", "product_id": "54738-518_5cc86981-732a-038f-e053-2991aa0a19d4", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "54738-518", "generic_name": "Simethicone", "labeler_name": "Richmond Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Simethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "80 mg/1"}], "application_number": "part332", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20110301", "listing_expiration_date": "20261231"}