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 |
|---|---|---|---|---|---|---|
| Revasol Peptic Relief | BISMUTH SUBSALICYLATE | Rnv LLC | 30dc3a0a-3496-4bdf-e063-6394a90a62fd | 2025-03-21 | Warnings | M008 |
| TopCare Bismuth Stomach Relief | BISMUTH | TopCo | 308f4b2a-22ff-42b9-e063-6394a90acc75 | 2025-03-17 | Warnings | M008 |
| Ultra Strength Stomach Relief | BISMUTH SUBSALICYLATE | Guardian Drug Company | 25175eac-d15f-ce0d-e063-6394a90a0650 | 2025-03-10 | Warnings | M008 |
| Pink Bismuth Regular Strength | BISMUTH SUBSALICYLATE | Discount Drug Mart, Inc | 2e0c675e-72ce-4a22-e063-6394a90a3dff | 2025-02-27 | Warnings | M008 |
| Pink Bismuth | BISMUTH SUBSALICYLATE | Discount Drug Mart, Inc | 2e0ce5dd-9eb5-8568-e063-6394a90a1a29 | 2025-02-27 | Warnings | M008 |
| Maximum Strength Pink Bismuth | BISMUTH SUBSALICYLATE | Discount Drug Mart, Inc | 2e0d4508-e5a1-ba46-e063-6394a90aec2a | 2025-02-27 | Warnings | M008 |
| Pink Bismuth Original | BISMUTH SUBSALICYLATE 525 MG | Discount Drug Mart, Inc | 2e0cb7d7-4c4f-824a-e063-6394a90aa3a4 | 2025-02-27 | Warnings | M008 |
| SIMETHICONE | SIMETHICONE | NuCare Pharmaceuticals,Inc. | e07f6acc-1b75-d8eb-e053-2a95a90a7d9b | 2025-02-24 | Warnings | M008 |
| Stomach Relief | BISMUTH SUBSALICYLATE | Harris Teeter, LLC | 2c51458b-869c-0283-e063-6394a90a4ff7 | 2025-02-12 | Warnings | M008 |
| Max Strength Stomach Relief | BISMUTH SUBSALICYLATE | Harris Teeter, LLC | 2c516139-0a6a-5ba6-e063-6394a90aa14a | 2025-02-12 | Warnings | M008 |
| Bismuth Subsalicylate | BISMUTH SUBSALICYLATE | LEADER/ Cardinal Health 110, Inc. | d4af6694-910c-da17-e053-2995a90a8454 | 2025-02-11 | Warnings | M008 |
| Regular Strength Stomach Relief | BISMUTH SUBSALICYLATE | DOLGENCORP, INC. | f2ec112f-213c-8a23-e053-2995a90a5f3f | 2025-02-10 | Warnings | M008 |
| Maximum Strength Stomach Relief | BISMUTH SUBSALICYLATE | Guardian Drug Company | af899b52-7d8c-4485-9fb8-006dae53568a | 2025-02-10 | Warnings | M008 |
| CVS Health Stomach Relief SOFTGEL | BISMUTH SUBSALICYLATE | CVS Pharmacy, Inc. | 273013b3-9f79-873d-e063-6394a90a6640 | 2025-01-24 | Warnings | M008 |
| GNP Pink Bismuth | BISMUTH SUBSALICYLATE | Amerisource Bergen | 9f5df648-298a-43e3-b250-8db6786fc93f | 2025-01-20 | Warnings | M008 |
| Bismuth Subsalicylate 262 mg | BISMUTH SUBSALICYLATE | Reliable 1 Laboratories LLC | 2e40ffd8-1afa-43af-e054-00144ff8d46c | 2025-01-15 | Warnings | M008 |
| Equate Stomach Relief | BISMUTH SUBSALICYLATE | Wal-Mart Stores, Inc. | 1e8ae968-6d40-4ac7-9bce-01d086584b61 | 2025-01-09 | Warnings | M008 |
| Stomach Relief | BISMUTH SUBSALICYLATE | CARDINAL HEALTH 110, LLC. DBA LEADER | b38d815b-a249-46d1-a9d0-4e8efab3e56b | 2025-01-06 | Warnings | M008 |
| Quality Choice Stomach Relief 528 | BISMUTH SUBSALICYLATE | Chain Drug Marketing Association Inc. | e065320d-09ee-4ab8-868a-ab3b4239e392 | 2025-01-03 | Warnings | M008 |
| HEB Stomach Relief | BISMUTH SUBSALICYLATE | H E B | fac642cf-f2f7-4857-b54f-82f1dcb400ab | 2024-12-26 | 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 |