pepto-bismol

Generic: bismuth subsalicylate

Labeler: asclemed usa inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pepto-bismol
Generic Name bismuth subsalicylate
Labeler asclemed usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bismuth subsalicylate 262 mg/1

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-490
Product ID 76420-490_412bf829-d172-4747-e063-6294a90a10c5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M008
Listing Expiration 2026-12-31
Marketing Start 2004-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420490
Hyphenated Format 76420-490

Supplemental Identifiers

RxCUI
308760 702384
UNII
62TEY51RR1
NUI
M0002611 N0000180183

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 pepto-bismol (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
  • 1 BOTTLE in 1 CARTON (76420-490-24) / 24 TABLET in 1 BOTTLE
source: ndc

Packages (1)

76420-490-24 1 BOTTLE in 1 CARTON (76420-490-24) / 24 TABLET in 1 BOTTLE

Ingredients (1)

bismuth subsalicylate (262 mg/1)

Linked Drug Pages (1)

Pepto-Bismol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "412bf829-d172-4747-e063-6294a90a10c5", "openfda": {"nui": ["M0002611", "N0000180183"], "unii": ["62TEY51RR1"], "rxcui": ["308760", "702384"], "spl_set_id": ["01b318d2-586d-4953-8f98-addc4e3cd441"], "pharm_class_cs": ["Bismuth [CS]"], "pharm_class_epc": ["Bismuth [EPC]"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76420-490-24)  / 24 TABLET in 1 BOTTLE", "package_ndc": "76420-490-24", "marketing_start_date": "20251015"}], "brand_name": "Pepto-Bismol", "product_id": "76420-490_412bf829-d172-4747-e063-6294a90a10c5", "dosage_form": "TABLET", "product_ndc": "76420-490", "generic_name": "Bismuth subsalicylate", "labeler_name": "ASCLEMED USA INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pepto-Bismol", "active_ingredients": [{"name": "BISMUTH SUBSALICYLATE", "strength": "262 mg/1"}], "application_number": "M008", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20040630", "listing_expiration_date": "20261231"}