simethicone 80mg

Generic: simethicone

Labeler: gendose pharmaceuticals, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone 80mg
Generic Name simethicone
Labeler gendose pharmaceuticals, llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dimethicone 80 mg/1

Manufacturer
Gendose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 77333-812
Product ID 77333-812_0e765edc-264e-533a-e063-6394a90a7c53
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2022-09-02

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 77333812
Hyphenated Format 77333-812

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 80mg (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 BLISTER PACK in 1 BOX (77333-812-10) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (77333-812-25)
source: ndc

Packages (1)

77333-812-10 100 BLISTER PACK in 1 BOX (77333-812-10) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (77333-812-25)

Ingredients (1)

dimethicone (80 mg/1)

Linked Drug Pages (1)

SIMETHICONE 80MG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e765edc-264e-533a-e063-6394a90a7c53", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["314216"], "spl_set_id": ["e7f470cf-f036-afd9-e053-2995a90a9186"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Gendose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX (77333-812-10)  / 1 TABLET, CHEWABLE in 1 BLISTER PACK (77333-812-25)", "package_ndc": "77333-812-10", "marketing_start_date": "20221015"}], "brand_name": "SIMETHICONE 80MG", "product_id": "77333-812_0e765edc-264e-533a-e063-6394a90a7c53", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "77333-812", "generic_name": "SIMETHICONE", "labeler_name": "Gendose Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SIMETHICONE 80MG", "active_ingredients": [{"name": "DIMETHICONE", "strength": "80 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220902", "listing_expiration_date": "20261231"}