simethicone 80 mg

Generic: simethicone

Labeler: reliable 1 laboratories llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone 80 mg
Generic Name simethicone
Labeler reliable 1 laboratories llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dimethicone 80 mg/1

Manufacturer
Reliable 1 Laboratories LLC

Identifiers & Regulatory

Product NDC 69618-033
Product ID 69618-033_2bc83c5b-6b22-871b-e063-6294a90adbc4
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 69618033
Hyphenated Format 69618-033

Supplemental Identifiers

RxCUI
314216
UPC
0369618033016
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 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
  • 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69618-033-01)
source: ndc

Packages (1)

69618-033-01 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69618-033-01)

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": "2bc83c5b-6b22-871b-e063-6294a90adbc4", "openfda": {"nui": ["N0000010282"], "upc": ["0369618033016"], "unii": ["92RU3N3Y1O"], "rxcui": ["314216"], "spl_set_id": ["32fb242b-7051-072c-e054-00144ff88e88"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Reliable 1 Laboratories LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69618-033-01)", "package_ndc": "69618-033-01", "marketing_start_date": "20180424"}], "brand_name": "Simethicone 80 mg", "product_id": "69618-033_2bc83c5b-6b22-871b-e063-6294a90adbc4", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "69618-033", "generic_name": "Simethicone", "labeler_name": "Reliable 1 Laboratories LLC", "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"}