signature care anti diarrheal anti gas

Generic: loperamide hydrochloride, simethicone

Labeler: safeway
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name signature care anti diarrheal anti gas
Generic Name loperamide hydrochloride, simethicone
Labeler safeway
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Safeway

Identifiers & Regulatory

Product NDC 21130-183
Product ID 21130-183_22865692-fb31-425b-ac78-2d3cd7998c04
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209837
Listing Expiration 2026-12-31
Marketing Start 2018-10-10

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21130183
Hyphenated Format 21130-183

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 signature care anti diarrheal anti gas (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
  • 24 BLISTER PACK in 1 CARTON (21130-183-62) / 1 TABLET in 1 BLISTER PACK
  • 18 BLISTER PACK in 1 CARTON (21130-183-89) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

21130-183-62 24 BLISTER PACK in 1 CARTON (21130-183-62) / 1 TABLET in 1 BLISTER PACK 21130-183-89 18 BLISTER PACK in 1 CARTON (21130-183-89) / 1 TABLET in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

signature care anti diarrheal anti gas ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "22865692-fb31-425b-ac78-2d3cd7998c04", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["53829e72-d22c-434d-a108-1972081a6efb"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Safeway"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (21130-183-62)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "21130-183-62", "marketing_start_date": "20190625"}, {"sample": false, "description": "18 BLISTER PACK in 1 CARTON (21130-183-89)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "21130-183-89", "marketing_start_date": "20181010"}], "brand_name": "signature care anti diarrheal anti gas", "product_id": "21130-183_22865692-fb31-425b-ac78-2d3cd7998c04", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "21130-183", "generic_name": "loperamide hydrochloride, simethicone", "labeler_name": "Safeway", "product_type": "HUMAN OTC DRUG", "brand_name_base": "signature care anti diarrheal anti gas", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}, {"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA209837", "marketing_category": "ANDA", "marketing_start_date": "20181010", "listing_expiration_date": "20261231"}