premier value infants gas relief

Generic: simethicone

Labeler: chain drug consortium
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name premier value infants gas relief
Generic Name simethicone
Labeler chain drug consortium
Dosage Form EMULSION
Routes
ORAL
Active Ingredients

dimethicone, unspecified 20 mg/.3mL

Manufacturer
Chain Drug Consortium

Identifiers & Regulatory

Product NDC 68016-670
Product ID 68016-670_2b8605c2-dcb3-48e0-ac8e-9c583d0a758d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2015-01-09

Pharmacologic Class

Classes
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68016670
Hyphenated Format 68016-670

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 premier value infants gas relief (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 (68016-670-00) / 30 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

68016-670-00 1 BOTTLE, DROPPER in 1 CARTON (68016-670-00) / 30 mL in 1 BOTTLE, DROPPER

Ingredients (1)

dimethicone, unspecified (20 mg/.3mL)

Linked Drug Pages (1)

premier value infants gas relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b8605c2-dcb3-48e0-ac8e-9c583d0a758d", "openfda": {"unii": ["92RU3N3Y1O"], "rxcui": ["198857"], "spl_set_id": ["7b887e53-a70a-4f33-9472-e1175b24400a"], "manufacturer_name": ["Chain Drug Consortium"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68016-670-00)  / 30 mL in 1 BOTTLE, DROPPER", "package_ndc": "68016-670-00", "marketing_start_date": "20150109"}], "brand_name": "premier value infants gas relief", "product_id": "68016-670_2b8605c2-dcb3-48e0-ac8e-9c583d0a758d", "dosage_form": "EMULSION", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "68016-670", "generic_name": "Simethicone", "labeler_name": "Chain Drug Consortium", "product_type": "HUMAN OTC DRUG", "brand_name_base": "premier value infants gas relief", "active_ingredients": [{"name": "DIMETHICONE, UNSPECIFIED", "strength": "20 mg/.3mL"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150109", "listing_expiration_date": "20261231"}