imodium multi-symptom relief

Generic: loperamide hydrochloride and dimethicone

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name imodium multi-symptom relief
Generic Name loperamide hydrochloride and dimethicone
Labeler kenvue brands llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-338
Product ID 50580-338_490ec903-14a6-e576-e063-6294a90a6d13
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021140
Listing Expiration 2027-12-31
Marketing Start 2008-07-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580338
Hyphenated Format 50580-338

Supplemental Identifiers

RxCUI
978001 1426827
UPC
0300450212122
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 imodium multi-symptom relief (source: ndc)
Generic Name loperamide hydrochloride and dimethicone (source: ndc)
Application Number NDA021140 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (50580-338-06) / 6 TABLET in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (50580-338-12) / 6 TABLET in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (50580-338-18) / 6 TABLET in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (50580-338-61) / 6 TABLET in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (50580-338-64) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (5)

50580-338-06 1 BLISTER PACK in 1 CARTON (50580-338-06) / 6 TABLET in 1 BLISTER PACK 50580-338-12 2 BLISTER PACK in 1 CARTON (50580-338-12) / 6 TABLET in 1 BLISTER PACK 50580-338-18 3 BLISTER PACK in 1 CARTON (50580-338-18) / 6 TABLET in 1 BLISTER PACK 50580-338-61 4 BLISTER PACK in 1 CARTON (50580-338-61) / 6 TABLET in 1 BLISTER PACK 50580-338-64 4 BLISTER PACK in 1 CARTON (50580-338-64) / 6 TABLET in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

IMODIUM Multi-Symptom Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "490ec903-14a6-e576-e063-6294a90a6d13", "openfda": {"nui": ["N0000010282"], "upc": ["0300450212122"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001", "1426827"], "spl_set_id": ["ecb91e47-2b0c-47c8-9256-4623d8bc825e"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50580-338-06)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "50580-338-06", "marketing_start_date": "20250331"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-338-12)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "50580-338-12", "marketing_start_date": "20080701"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (50580-338-18)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "50580-338-18", "marketing_start_date": "20080701"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (50580-338-61)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "50580-338-61", "marketing_start_date": "20190624"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (50580-338-64)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "50580-338-64", "marketing_start_date": "20240226"}], "brand_name": "IMODIUM Multi-Symptom Relief", "product_id": "50580-338_490ec903-14a6-e576-e063-6294a90a6d13", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "50580-338", "generic_name": "loperamide hydrochloride and dimethicone", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "IMODIUM", "brand_name_suffix": "Multi-Symptom Relief", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}, {"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "NDA021140", "marketing_category": "NDA", "marketing_start_date": "20080701", "listing_expiration_date": "20271231"}