pep tum

Generic: bismuth subsalicylate

Labeler: first aid direct
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pep tum
Generic Name bismuth subsalicylate
Labeler first aid direct
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

bismuth subsalicylate 262 mg/1

Manufacturer
First Aid Direct

Identifiers & Regulatory

Product NDC 53117-046
Product ID 53117-046_affef754-2097-48fc-975b-63a35c991da7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Listing Expiration 2026-12-31
Marketing Start 2014-12-23

Pharmacologic Class

Established (EPC)
bismuth [epc]
Chemical Structure
bismuth [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53117046
Hyphenated Format 53117-046

Supplemental Identifiers

RxCUI
308761
UNII
62TEY51RR1
NUI
M0002611 N0000180183

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 pep tum (source: ndc)
Generic Name bismuth subsalicylate (source: ndc)
Application Number M008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 262 mg/1
source: ndc
Packaging
  • 30 CELLO PACK in 1 CARTON (53117-046-85) / 1 TABLET, CHEWABLE in 1 CELLO PACK
source: ndc

Packages (1)

53117-046-85 30 CELLO PACK in 1 CARTON (53117-046-85) / 1 TABLET, CHEWABLE in 1 CELLO PACK

Ingredients (1)

bismuth subsalicylate (262 mg/1)

Linked Drug Pages (1)

Pep Tum ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "affef754-2097-48fc-975b-63a35c991da7", "openfda": {"nui": ["M0002611", "N0000180183"], "unii": ["62TEY51RR1"], "rxcui": ["308761"], "spl_set_id": ["bf966e9f-2f95-41cd-a6e5-b8eb521181d8"], "pharm_class_cs": ["Bismuth [CS]"], "pharm_class_epc": ["Bismuth [EPC]"], "manufacturer_name": ["First Aid Direct"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CELLO PACK in 1 CARTON (53117-046-85)  / 1 TABLET, CHEWABLE in 1 CELLO PACK", "package_ndc": "53117-046-85", "marketing_start_date": "20141223"}], "brand_name": "Pep Tum", "product_id": "53117-046_affef754-2097-48fc-975b-63a35c991da7", "dosage_form": "TABLET, CHEWABLE", "product_ndc": "53117-046", "generic_name": "Bismuth subsalicylate", "labeler_name": "First Aid Direct", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pep Tum", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "262 mg/1"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141223", "listing_expiration_date": "20261231"}