simethicone infant gas relief drops

Generic: simethicone

Labeler: atlantic biologicals corp.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone infant gas relief drops
Generic Name simethicone
Labeler atlantic biologicals corp.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

dimethicone 20 mg/.3mL

Manufacturer
Atlantic Biologicals Corp.

Identifiers & Regulatory

Product NDC 17856-1017
Product ID 17856-1017_462ade67-6223-377c-e063-6294a90ab79b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2025-02-20

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178561017
Hyphenated Format 17856-1017

Supplemental Identifiers

RxCUI
198857
UNII
92RU3N3Y1O
NUI
N0000010282

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 infant gas relief drops (source: ndc)
Generic Name simethicone (source: ndc)
Application Number M002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/.3mL
source: ndc
Packaging
  • 120 SYRINGE in 1 CASE (17856-1017-1) / .3 mL in 1 SYRINGE
  • 120 SYRINGE in 1 CASE (17856-1017-2) / .3 mL in 1 SYRINGE
  • 120 SYRINGE in 1 CASE (17856-1017-3) / .6 mL in 1 SYRINGE
  • 120 SYRINGE in 1 CASE (17856-1017-4) / .6 mL in 1 SYRINGE
  • 60 SYRINGE in 1 CASE (17856-1017-5) / 1.2 mL in 1 SYRINGE
  • 48 SYRINGE in 1 CASE (17856-1017-6) / 5 mL in 1 SYRINGE
  • 60 SYRINGE in 1 CASE (17856-1017-7) / .6 mL in 1 SYRINGE
  • 120 SYRINGE in 1 CASE (17856-1017-8) / 2 mL in 1 SYRINGE
source: ndc

Packages (8)

17856-1017-1 120 SYRINGE in 1 CASE (17856-1017-1) / .3 mL in 1 SYRINGE 17856-1017-2 120 SYRINGE in 1 CASE (17856-1017-2) / .3 mL in 1 SYRINGE 17856-1017-3 120 SYRINGE in 1 CASE (17856-1017-3) / .6 mL in 1 SYRINGE 17856-1017-4 120 SYRINGE in 1 CASE (17856-1017-4) / .6 mL in 1 SYRINGE 17856-1017-5 60 SYRINGE in 1 CASE (17856-1017-5) / 1.2 mL in 1 SYRINGE 17856-1017-6 48 SYRINGE in 1 CASE (17856-1017-6) / 5 mL in 1 SYRINGE 17856-1017-7 60 SYRINGE in 1 CASE (17856-1017-7) / .6 mL in 1 SYRINGE 17856-1017-8 120 SYRINGE in 1 CASE (17856-1017-8) / 2 mL in 1 SYRINGE

Ingredients (1)

dimethicone (20 mg/.3mL)

Linked Drug Pages (1)

SIMETHICONE INFANT Gas Relief Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "462ade67-6223-377c-e063-6294a90ab79b", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["198857"], "spl_set_id": ["410d80fc-e55b-08d0-e063-6294a90aba73"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Atlantic Biologicals Corp."]}, "finished": true, "packaging": [{"sample": false, "description": "120 SYRINGE in 1 CASE (17856-1017-1)  / .3 mL in 1 SYRINGE", "package_ndc": "17856-1017-1", "marketing_start_date": "20251013"}, {"sample": false, "description": "120 SYRINGE in 1 CASE (17856-1017-2)  / .3 mL in 1 SYRINGE", "package_ndc": "17856-1017-2", "marketing_start_date": "20251013"}, {"sample": false, "description": "120 SYRINGE in 1 CASE (17856-1017-3)  / .6 mL in 1 SYRINGE", "package_ndc": "17856-1017-3", "marketing_start_date": "20251013"}, {"sample": false, "description": "120 SYRINGE in 1 CASE (17856-1017-4)  / .6 mL in 1 SYRINGE", "package_ndc": "17856-1017-4", "marketing_start_date": "20251013"}, {"sample": false, "description": "60 SYRINGE in 1 CASE (17856-1017-5)  / 1.2 mL in 1 SYRINGE", "package_ndc": "17856-1017-5", "marketing_start_date": "20251013"}, {"sample": false, "description": "48 SYRINGE in 1 CASE (17856-1017-6)  / 5 mL in 1 SYRINGE", "package_ndc": "17856-1017-6", "marketing_start_date": "20251013"}, {"sample": false, "description": "60 SYRINGE in 1 CASE (17856-1017-7)  / .6 mL in 1 SYRINGE", "package_ndc": "17856-1017-7", "marketing_start_date": "20251218"}, {"sample": false, "description": "120 SYRINGE in 1 CASE (17856-1017-8)  / 2 mL in 1 SYRINGE", "package_ndc": "17856-1017-8", "marketing_start_date": "20251218"}], "brand_name": "SIMETHICONE INFANT Gas Relief Drops", "product_id": "17856-1017_462ade67-6223-377c-e063-6294a90ab79b", "dosage_form": "SUSPENSION", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "17856-1017", "generic_name": "Simethicone", "labeler_name": "Atlantic Biologicals Corp.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SIMETHICONE INFANT", "brand_name_suffix": "Gas Relief Drops", "active_ingredients": [{"name": "DIMETHICONE", "strength": "20 mg/.3mL"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250220", "listing_expiration_date": "20261231"}