simethicone

Generic: simethicone

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone
Generic Name simethicone
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dimethicone 80 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-649
Product ID 71610-649_2b5afc84-182d-07ef-e063-6294a90a9f3e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2004-01-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610649
Hyphenated Format 71610-649

Supplemental Identifiers

RxCUI
314216
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 (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
  • 4 TABLET, CHEWABLE in 1 BOTTLE (71610-649-04)
source: ndc

Packages (1)

71610-649-04 4 TABLET, CHEWABLE in 1 BOTTLE (71610-649-04)

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": "2b5afc84-182d-07ef-e063-6294a90a9f3e", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["314216"], "spl_set_id": ["5df94be7-0bc9-4be1-9982-8193e3a3c8ef"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, CHEWABLE in 1 BOTTLE (71610-649-04)", "package_ndc": "71610-649-04", "marketing_start_date": "20220519"}], "brand_name": "SIMETHICONE", "product_id": "71610-649_2b5afc84-182d-07ef-e063-6294a90a9f3e", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "71610-649", "generic_name": "Simethicone", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SIMETHICONE", "active_ingredients": [{"name": "DIMETHICONE", "strength": "80 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20040101", "listing_expiration_date": "20261231"}