topcare health extra strength gas relief softgel

Generic: simethicone

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare health extra strength gas relief softgel
Generic Name simethicone
Labeler topco associates llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dimethicone, unspecified 125 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-538
Product ID 76162-538_3e0ea0d4-f46d-47be-b087-7e4538b22915
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2025-08-01

Pharmacologic Class

Classes
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162538
Hyphenated Format 76162-538

Supplemental Identifiers

RxCUI
198852
UNII
92RU3N3Y1O

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 topcare health extra strength gas relief softgel (source: ndc)
Generic Name simethicone (source: ndc)
Application Number M002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (76162-538-05) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

76162-538-05 2 BLISTER PACK in 1 CARTON (76162-538-05) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (1)

dimethicone, unspecified (125 mg/1)

Linked Drug Pages (1)

TopCare health EXTRA STRENGTH Gas Relief SOFTGEL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e0ea0d4-f46d-47be-b087-7e4538b22915", "openfda": {"unii": ["92RU3N3Y1O"], "rxcui": ["198852"], "spl_set_id": ["2ea0eb22-f679-d136-e063-6294a90a1dfe"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (76162-538-05)  / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "76162-538-05", "marketing_start_date": "20250801"}], "brand_name": "TopCare health EXTRA STRENGTH Gas Relief SOFTGEL", "product_id": "76162-538_3e0ea0d4-f46d-47be-b087-7e4538b22915", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "76162-538", "generic_name": "Simethicone", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare health EXTRA STRENGTH Gas Relief SOFTGEL", "active_ingredients": [{"name": "DIMETHICONE, UNSPECIFIED", "strength": "125 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}