Pepto
- Product NDC
- 37000-538
- 11-digit product format
- 370000538
- Labeler code
- 37000
- Product ID
- 37000-538_eeb38418-92fb-4372-e053-2a95a90a67f2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bismuth subsalicylate
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M008
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2018-03-01
- Marketing end
- 0000-00-00
- Substance
- BISMUTH SUBSALICYLATE
- Active strength
- 525 mg/30mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 37000-538 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 37000-538 | 37000-538-04 | D | Discontinued by firm | 2026-10-15 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37000-538-04 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-1bb9-a910-e053-dadaa90a0b85 | Pepto ® Diarrhea |
| 37000-538-04 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1bb9-a910-e053-dadaa90a0b85 | Pepto ® Diarrhea |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37000-538-04 | PeptoDiarrhea | 118 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 118 | 10 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Walgreen Stomach Relief | BISMUTH SUBSALICYLATE | WALGREENS CO. | 53fdceb2-68ea-42b9-87eb-f202e96eb524 | 2025-11-25 | Warnings | M008 |
| Walgreen | BISMUTH SUBSALICYLATE | WALGREEN CO. | 73231515-840f-4086-86da-4b815d664c13 | 2025-11-25 | Warnings | M008 |
| Percy Medicine | BISMUTH SUBSALICYLATE | Merrick Medicine Company, Inc | 08dd53b7-8345-4849-9155-60429cbe2c51 | 2025-11-11 | Warnings | M008 |
| Stomach Relief | BISMUTH SUBSALICYLATE | Family Dollar (FAMILY WELLNESS) | d28ef2ae-2b0a-4f32-9bc1-6803806f3c81 | 2025-11-11 | Warnings | M008 |
| TopCare Regular Strength | BISMUTH SUBSALICYLATE | TOPCO ASSOCIATES LLC | 2619720a-d926-4b17-899c-54d49c78802c | 2025-11-10 | Warnings | M008 |
| TopCare Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | TOPCO ASSOCIATES LLC | b93a0b38-eb5f-47c0-8112-75505e46f7c3 | 2025-11-10 | Warnings | M008 |
| TopCare Stomach Relief Ultra Strength | BISMUTH SUBSALICYLATE | TOPCO ASSOCIATES LLC | e745e693-9e45-43b0-b26c-99ca891b74b0 | 2025-11-10 | Warnings | M008 |
| Stomach Relief Ultra | BISMUTH SUBSALICYLATE | Family Dollar (FAMILY WELLNESS) | 6298b856-90ea-4054-bda3-70f92b14611d | 2025-11-10 | Warnings | M008 |
| Stomach Relief | BISMUTH SUBSALICYLATE | Family Dollar (FAMILY WELLNESS) | 61309786-96ee-4d9b-8dd3-8e4a91ebe88c | 2025-11-07 | Warnings | M008 |
| up and up digestive relief | BISMUTH SUBSALICYLATE | Target Corporation | 5731025d-ffaa-4b31-971f-e58b921e40ed | 2025-11-05 | Warnings | M008 |
| ULTRA STRENGHT PINK BISMUTH | BISMUTH SUBSALICYLATE | TARGET CORPORATION | 20063215-f657-487b-9530-6df0181b440a | 2025-11-05 | Warnings | M008 |
| up and up 5-symptom digestive relief | BISMUTH SUBSALICYLATE | Target Corporation | 7f6b2960-943d-464c-9ff9-4649a8ab4a4e | 2025-11-04 | Warnings | M008 |
| up and up 5-symptom digestive relief | BISMUTH SUBSALICYLATE | Target Corporation | 6462e224-5ee7-4556-90f2-994eaf89b71b | 2025-11-04 | Warnings | M008 |
| Stomach Relief | BISMUTH SUBSALICYLATE | SAFEWAY | ba698d38-83f1-4257-9c43-e7a55dbb206e | 2025-10-29 | Warnings | M008 |
| Digestive Relief | BISMUTH SUBSALICYLATE | SAFEWAY | 5538d56a-b258-4260-b51b-f5131bd76885 | 2025-10-29 | Warnings | M008 |
| Chewable Stomach Relief | BISMUTH SUBSALICYLATE | PUBLIX SUPER MARKETS INC, | 2a316e06-5c16-46b8-b9ac-71fe0f92c515 | 2025-10-28 | Warnings | M008 |
| PUBLIX Regular Strength Pink Bismuth | BISMUTH SUBSALICYLATE | PUBLIX SUPER MARKETS, INC | a9b2da55-5171-4702-9808-5b937182da02 | 2025-10-28 | Warnings | M008 |
| PUBLIX Stomach Relief Ultra Strength | BISMUTH SUBSALICYLATE | PUBLIX SUPER MARKETS, INC | 4be86e84-fddf-4eb5-a519-64009d0e69fc | 2025-10-28 | Warnings | M008 |
| Pepto-Bismol | BISMUTH SUBSALICYLATE | ASCLEMED USA INC. | 01b318d2-586d-4953-8f98-addc4e3cd441 | 2025-10-15 | Warnings | M008 |
| Kaopectate | BISMUTH SUBSALICYLATE | KRAMER LABORATORIES | 18b79c8c-b2fd-449b-a154-7158c9b13cdd | 2025-10-15 | Warnings | M008 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-538-04 | 37000053804 | 118 mL in 1 BOTTLE, PLASTIC (37000-538-04) | 118 ml | 2019-03-01 | 0000-00-00 | No | No | Current |