careone diarrhea and gas control

Generic: loperamide hydrochloride, simethicone

Labeler: american sales company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name careone diarrhea and gas control
Generic Name loperamide hydrochloride, simethicone
Labeler american sales company
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dimethicone 125 mg/1, loperamide hydrochloride 2 mg/1

Manufacturer
American Sales Company

Identifiers & Regulatory

Product NDC 41520-772
Product ID 41520-772_a42e54bf-ac3e-48f8-b31a-0b33efd8ae32
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209837
Listing Expiration 2026-12-31
Marketing Start 2019-01-31

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 41520772
Hyphenated Format 41520-772

Supplemental Identifiers

RxCUI
978001
UNII
92RU3N3Y1O 77TI35393C
NUI
N0000010282

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 careone diarrhea and gas control (source: ndc)
Generic Name loperamide hydrochloride, simethicone (source: ndc)
Application Number ANDA209837 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (41520-772-53) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

41520-772-53 12 BLISTER PACK in 1 CARTON (41520-772-53) / 1 TABLET in 1 BLISTER PACK

Ingredients (2)

dimethicone (125 mg/1) loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

CareOne Diarrhea and Gas Control ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a42e54bf-ac3e-48f8-b31a-0b33efd8ae32", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["dfa3db5a-cef6-4ed5-b9f1-a20b6d1657b3"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["American Sales Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (41520-772-53)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "41520-772-53", "marketing_start_date": "20190131"}], "brand_name": "CareOne Diarrhea and Gas Control", "product_id": "41520-772_a42e54bf-ac3e-48f8-b31a-0b33efd8ae32", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "41520-772", "generic_name": "loperamide hydrochloride, simethicone", "labeler_name": "American Sales Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CareOne Diarrhea and Gas Control", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}, {"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA209837", "marketing_category": "ANDA", "marketing_start_date": "20190131", "listing_expiration_date": "20261231"}