premier value extra strength

Generic: simethicone

Labeler: pharmacy value alliance, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name premier value extra strength
Generic Name simethicone
Labeler pharmacy value alliance, llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dimethicone, unspecified 125 mg/1

Manufacturer
PHARMACY VALUE ALLIANCE, LLC

Identifiers & Regulatory

Product NDC 68016-811
Product ID 68016-811_a73731e6-56d7-43a9-8623-dc9859be4f38
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2019-05-15

Pharmacologic Class

Classes
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68016811
Hyphenated Format 68016-811

Supplemental Identifiers

RxCUI
314221
UPC
0840986019197
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 extra strength (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 (68016-811-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (1)

68016-811-18 2 BLISTER PACK in 1 CARTON (68016-811-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

dimethicone, unspecified (125 mg/1)

Linked Drug Pages (1)

Premier Value Extra Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a73731e6-56d7-43a9-8623-dc9859be4f38", "openfda": {"upc": ["0840986019197"], "unii": ["92RU3N3Y1O"], "rxcui": ["314221"], "spl_set_id": ["df2b1b62-5bd2-4d02-86c2-537b965a8d20"], "manufacturer_name": ["PHARMACY VALUE ALLIANCE, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (68016-811-18)  / 9 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "68016-811-18", "marketing_start_date": "20190515"}], "brand_name": "Premier Value Extra Strength", "product_id": "68016-811_a73731e6-56d7-43a9-8623-dc9859be4f38", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "68016-811", "generic_name": "Simethicone", "labeler_name": "PHARMACY VALUE ALLIANCE, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Premier Value", "brand_name_suffix": "Extra Strength", "active_ingredients": [{"name": "DIMETHICONE, UNSPECIFIED", "strength": "125 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190515", "listing_expiration_date": "20261231"}