anti diarrheal anti gas

Generic: loperamide hydrochloride, simethicone

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti diarrheal anti gas
Generic Name loperamide hydrochloride, simethicone
Labeler h e b
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-714
Product ID 37808-714_09c4848d-0d0f-4400-97a9-8ae26913e540
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209837
Listing Expiration 2026-12-31
Marketing Start 2018-11-15

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808714
Hyphenated Format 37808-714

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 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
  • 12 BLISTER PACK in 1 CARTON (37808-714-53) / 1 TABLET in 1 BLISTER PACK
  • 24 BLISTER PACK in 1 CARTON (37808-714-62) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

37808-714-53 12 BLISTER PACK in 1 CARTON (37808-714-53) / 1 TABLET in 1 BLISTER PACK 37808-714-62 24 BLISTER PACK in 1 CARTON (37808-714-62) / 1 TABLET in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

anti diarrheal anti gas ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "09c4848d-0d0f-4400-97a9-8ae26913e540", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["35cff261-932e-4b2e-ab21-80969c27fa92"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (37808-714-53)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "37808-714-53", "marketing_start_date": "20181115"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (37808-714-62)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "37808-714-62", "marketing_start_date": "20200203"}], "brand_name": "anti diarrheal anti gas", "product_id": "37808-714_09c4848d-0d0f-4400-97a9-8ae26913e540", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "37808-714", "generic_name": "loperamide hydrochloride, simethicone", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "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": "20181115", "listing_expiration_date": "20261231"}