simethicone

Generic: simethicone

Labeler: softgel healthcare private limited
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone
Generic Name simethicone
Labeler softgel healthcare private limited
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dimethicone 250 mg/1

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 35916-1940
Product ID 35916-1940_47de40b6-7551-02cd-e063-6394a90a5b0a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2027-12-31
Marketing Start 2025-10-28

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 359161940
Hyphenated Format 35916-1940

Supplemental Identifiers

RxCUI
412111
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
  • 250 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1940-1)
  • 5 BLISTER PACK in 1 CARTON (35916-1940-2) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (2)

35916-1940-1 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1940-1) 35916-1940-2 5 BLISTER PACK in 1 CARTON (35916-1940-2) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (1)

dimethicone (250 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": "47de40b6-7551-02cd-e063-6394a90a5b0a", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["412111"], "spl_set_id": ["322e6cb3-0ddc-9300-e063-6294a90a972a"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["SOFTGEL HEALTHCARE PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1940-1)", "package_ndc": "35916-1940-1", "marketing_start_date": "20251028"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (35916-1940-2)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "35916-1940-2", "marketing_start_date": "20251028"}], "brand_name": "Simethicone", "product_id": "35916-1940_47de40b6-7551-02cd-e063-6394a90a5b0a", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "35916-1940", "generic_name": "Simethicone", "labeler_name": "SOFTGEL HEALTHCARE PRIVATE LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Simethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "250 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251028", "listing_expiration_date": "20271231"}