Pepto-Bismol
- Product NDC
- 37000-477
- Requested package NDC
- 37000-477-10
- 11-digit product format
- 370000477
- Labeler code
- 37000
- Product ID
- 37000-477_e5f8d36d-6c56-08bf-e053-2a95a90afdc5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bismuth subsalicylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M008
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2004-06-30
- Marketing end
- 0000-00-00
- Substance
- BISMUTH SUBSALICYLATE
- Active strength
- 262 mg/1
- 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 package | package | 37000-477 | 37000-477-10 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 37000-477-01 | 2021-02-12 | Pepto-Bismol® Tablets |
| 37000-477-09 | 2021-02-12 | Pepto-Bismol® Tablets |
| 37000-477-10 | 2021-02-12 | Pepto-Bismol® Tablets |
| 37000-477-12 | 2021-02-12 | Pepto-Bismol® Tablets |
| 37000-477-24 | 2021-02-12 | Pepto-Bismol® Tablets |
| 37000-477-01 | 2021-01-29 | Pepto-Bismol® Tablets |
| 37000-477-09 | 2021-01-29 | Pepto-Bismol® Tablets |
| 37000-477-10 | 2021-01-29 | Pepto-Bismol® Tablets |
| 37000-477-12 | 2021-01-29 | Pepto-Bismol® Tablets |
| 37000-477-24 | 2021-01-29 | Pepto-Bismol® Tablets |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 37000-477-09 | EA - Each | 37000-477 | 0242e6e2-de1b-426d-afce-d5e27e0ea3b0 | 1 | 2015-10-02 |
| 37000-477-10 | EA - Each | 37000-477 | e4fa3a27-8011-4582-8a10-be0ed001120b | 1 | 2015-10-02 |
| 37000-477-12 | EA - Each | 37000-477 | de063b90-0b74-4b42-881b-efa0a8f316e6 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308761 | bismuth subsalicylate 262 MG Chewable Tablet | PSN | e02bead2-0be9-41b0-98a7-fd0c3f57def0 | 17 |
| 211151 | Pepto-Bismol 262 MG Chewable Tablet | PSN | e02bead2-0be9-41b0-98a7-fd0c3f57def0 | 17 |
| 211151 | bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol] | SBD | e02bead2-0be9-41b0-98a7-fd0c3f57def0 | 17 |
| 308761 | bismuth subsalicylate 262 MG Chewable Tablet | SCD | e02bead2-0be9-41b0-98a7-fd0c3f57def0 | 17 |
| 211151 | Pepto-bismol 262 MG Chewable Tablet | SY | e02bead2-0be9-41b0-98a7-fd0c3f57def0 | 17 |
| 211151 | Pepto-Bismol InstaCool 262 MG Chewable Tablet | SY | e02bead2-0be9-41b0-98a7-fd0c3f57def0 | 17 |
| 211151 | Pepto-Bismol To-Go 262 MG Chewable Tablet | SY | e02bead2-0be9-41b0-98a7-fd0c3f57def0 | 17 |
| 308761 | bismuth subsalicylate 262 MG Chewable Tablet | PSN | 0b3a5a1a-2c1b-48ce-a3fe-bbcda23631f3 | 1 |
| 211151 | Pepto-Bismol 262 MG Chewable Tablet | PSN | 0b3a5a1a-2c1b-48ce-a3fe-bbcda23631f3 | 1 |
| 211151 | bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol] | SBD | 0b3a5a1a-2c1b-48ce-a3fe-bbcda23631f3 | 1 |
| 308761 | bismuth subsalicylate 262 MG Chewable Tablet | SCD | 0b3a5a1a-2c1b-48ce-a3fe-bbcda23631f3 | 1 |
| 211151 | Pepto-bismol 262 MG Chewable Tablet | SY | 0b3a5a1a-2c1b-48ce-a3fe-bbcda23631f3 | 1 |
| 211151 | Pepto-Bismol InstaCool 262 MG Chewable Tablet | SY | 0b3a5a1a-2c1b-48ce-a3fe-bbcda23631f3 | 1 |
| 211151 | Pepto-Bismol To-Go 262 MG Chewable Tablet | SY | 0b3a5a1a-2c1b-48ce-a3fe-bbcda23631f3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-477-10 | 37000047710 | 8 CELLO PACK in 1 CARTON (37000-477-10) > 6 TABLET in 1 CELLO PACK | 8 cello pack | 2004-06-30 | 0000-00-00 | No | No | Current |