simethicone

Generic: simethicone

Labeler: humanwell puracap pharmaceutical (wuhan) co., ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone
Generic Name simethicone
Labeler humanwell puracap pharmaceutical (wuhan) co., ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dimethicone 180 mg/1

Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd

Identifiers & Regulatory

Product NDC 53345-036
Product ID 53345-036_27c818a0-ee73-b3e3-e063-6394a90a83e9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2016-07-25

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53345036
Hyphenated Format 53345-036

Supplemental Identifiers

RxCUI
252294
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 M002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 1 BAG in 1 BOX (53345-036-01) / 25000 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (1)

53345-036-01 1 BAG in 1 BOX (53345-036-01) / 25000 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (1)

dimethicone (180 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": "27c818a0-ee73-b3e3-e063-6394a90a83e9", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["252294"], "spl_set_id": ["346df37d-b0fc-4fa5-8c19-492fed58c239"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 BOX (53345-036-01)  / 25000 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "53345-036-01", "marketing_start_date": "20160725"}], "brand_name": "Simethicone", "product_id": "53345-036_27c818a0-ee73-b3e3-e063-6394a90a83e9", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "53345-036", "generic_name": "Simethicone", "labeler_name": "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Simethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "180 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160725", "listing_expiration_date": "20261231"}