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 |
|---|---|---|---|---|---|---|
| RITE AID Ultra Strnght Pink Bismuth | BISMUTH SUBSALICYLATE | RITE AID CORPORATION | 3ffb2bb9-6d6a-4c38-ac59-0ac0d754de28 | 2024-10-30 | Warnings | M008 |
| Premier Value Diarrhea Relief Vanilla Flavor | BISMUTH SUBSALICYLATE | PHARMACY VALUE ALLIANCE, LLC | 1c6e464c-d5c6-4658-a0d8-bba87369a0c3 | 2024-10-28 | Warnings | M008 |
| Premier Value | BISMUTH SUBSALICYLATE | CHAIN DRUG CONSORTIUM,LLC | 3b8850e8-f9c2-4d52-aadd-8e037fabdee4 | 2024-10-28 | Warnings | M008 |
| Goodsense maximum strength Stomach Relief 528 | BISMUTH SUBSALICYLATE | Good Sense (Geiss, Destin & Dunn, Inc.) | 19a4191a-6196-f8ac-e063-6394a90a47ab | 2024-09-17 | Warnings | M008 |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | Best Choice (Valu Merchandisers Company) | 5ecc500c-12d0-41dd-acb4-9190023c9ed5 | 2024-09-16 | Warnings | M008 |
| Stomach Relief Ultra | BISMUTH SUBSALICYLATE | Best Choice (Valu Merchandisers Company) | ecbf9caf-b02b-434e-8f29-50839010e821 | 2024-09-16 | Warnings | M008 |
| Goodsense Regular strength Stomach Relief 122 | BISMUTH SUBSALICYLATE | Good Sense (Geiss, Destin & Dunn, Inc.) | 19a324bd-fa54-b899-e063-6394a90aaa73 | 2024-09-10 | Warnings | M008 |
| Ultra Bismuth | BISMUTH SUBSALICYLATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0fc01a1a-4b1d-4c78-9955-220984a8019c | 2024-08-30 | Warnings | M008 |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | b22e1a0f-9866-403b-93e8-6e0e4130a75e | 2024-08-29 | Warnings | M008 |
| Stomach Relief Ultra | BISMUTH SUBSALICYLATE | Rugby Laboratories, Inc. | 87394088-1d2e-4ca4-bbfe-1481c9d4a3ba | 2024-08-29 | Warnings | M008 |
| Soothe | BISMUTH SUBSALICYLATE | Walgreens | a2b2b0ce-034e-4857-bfca-0087bb31878e | 2024-07-25 | Warnings | M008 |
| 5-Symptom Digestive Relief | BISMUTH SUBSALICYLATE | TARGET CORPORATION | 07aa10e2-dd03-f32d-e063-6294a90aad0d | 2024-06-26 | Warnings | M008 |
| Stomach Relief | STOMACH RELIEF | Chain Drug Marketing Association, Inc. | 459abf99-63e8-43d7-a13c-9e4682698415 | 2024-06-21 | Warnings | M008 |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | Strategic Sourcing Services LLC | 2a018350-da22-4997-9181-661bb920afd3 | 2024-06-04 | Warnings | M008 |
| 5 Symptom Digestive Relief | BISMUTH SUBSALICYLATE | TARGET CORPORATION | 07a932fb-38eb-4b35-e063-6394a90ad61f | 2024-05-25 | Warnings | M008 |
| Soothe Ultra Strength | BISMUTH SUBSALICYLATE | Walgreens | ec96e6f2-b087-457e-9b95-30f3595deebb | 2024-05-21 | Warnings | M008 |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | Safeway, Inc. | 2bde4e41-ffbd-4d9d-ae00-e39a5c7264b3 | 2024-05-15 | Warnings | M008 |
| Ultra Stomach Relief | BISMUTH SUBSALICYLATE | Safeway, Inc. | 71ca1c0e-50dc-4970-ae0d-5f7be1eec6df | 2024-05-15 | Warnings | M008 |
| PEPT-ACHE | BISMUTH SUBSALICYLATE | JHK Inc dba American Safety & First Aid | 894c1912-cd24-4ddf-b7e7-dae9dd64b280 | 2024-04-24 | Warnings | M008 |
| Stomach Relief Ultra Strength | BISMUTH SUBSALICYLATE | P & L Development, LLC | cb5ca7ab-39cf-4b07-ac22-a00b214db102 | 2024-04-16 | 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 |