quality choice infants gas relief dye free

Generic: simethicone

Labeler: quality choice (chain drug marketing association)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name quality choice infants gas relief dye free
Generic Name simethicone
Labeler quality choice (chain drug marketing association)
Dosage Form EMULSION
Routes
ORAL
Active Ingredients

dimethicone, unspecified 20 mg/.3mL

Manufacturer
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)

Identifiers & Regulatory

Product NDC 83324-335
Product ID 83324-335_3d02651a-0fb7-6954-e063-6294a90aa9ef
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 83324335
Hyphenated Format 83324-335

Supplemental Identifiers

RxCUI
198857
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 quality choice infants gas relief dye free (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
  • 1 BOTTLE, DROPPER in 1 CARTON (83324-335-01) / 30 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

83324-335-01 1 BOTTLE, DROPPER in 1 CARTON (83324-335-01) / 30 mL in 1 BOTTLE, DROPPER

Ingredients (1)

dimethicone, unspecified (20 mg/.3mL)

Linked Drug Pages (1)

Quality Choice Infants Gas Relief Dye Free ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d02651a-0fb7-6954-e063-6294a90aa9ef", "openfda": {"unii": ["92RU3N3Y1O"], "rxcui": ["198857"], "spl_set_id": ["841b85ef-2ac8-4dac-8659-cffb7e1b1e05"], "manufacturer_name": ["QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (83324-335-01)  / 30 mL in 1 BOTTLE, DROPPER", "package_ndc": "83324-335-01", "marketing_start_date": "20250801"}], "brand_name": "Quality Choice Infants Gas Relief Dye Free", "product_id": "83324-335_3d02651a-0fb7-6954-e063-6294a90aa9ef", "dosage_form": "EMULSION", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "83324-335", "generic_name": "Simethicone", "labeler_name": "QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Quality Choice", "brand_name_suffix": "Infants Gas Relief Dye Free", "active_ingredients": [{"name": "DIMETHICONE, UNSPECIFIED", "strength": "20 mg/.3mL"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}