Pepto-Bismol
- Product NDC
- 37000-438
- 11-digit product format
- 370000438
- Labeler code
- 37000
- Product ID
- 37000-438_5d2c9a5e-039b-7740-e063-6394a90a4b1f
- 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 DRUG
- Marketing start
- 2018-03-01
- Substance
- BISMUTH SUBSALICYLATE
- Active strength
- 525 mg/30mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pepto-Bismol
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BISMUTH SUBSALICYLATE | 525 mg/30mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37000-438-04 | Pepto-Bismol | 118 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 118 | 18 | |
| 37000-438-08 | Pepto-Bismol | 236 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 236 | 18 | |
| 37000-438-12 | Pepto-Bismol | 354 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 354 | 18 | |
| 37000-438-16 | Pepto-Bismol | 473 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 473 | 18 | |
| 37000-438-24 | Pepto-Bismol | 354 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 354 | 18 | |
| 37000-438-24 | Pepto-Bismol | 2 in 1 CELLO PACK | SUSPENSION | 2 | 18 | |
| 37000-438-32 | Pepto-Bismol | 2 in 1 CELLO PACK | SUSPENSION | 2 | 18 | |
| 37000-438-32 | Pepto-Bismol | 473 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 473 | 18 | |
| 37000-438-34 | Pepto-Bismol | 100 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 100 | 18 |
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 |
|---|---|---|---|---|---|---|
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | P & L Development, LLC | 7a461b91-d11f-4cb9-be61-c7d91d278302 | 2024-04-16 | Warnings | M008 |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | Gobrands, Inc. (Goodnow) | cd647eb7-6e03-415c-8249-89c126824d00 | 2024-04-03 | Warnings | M008 |
| Stomach Relief Ultra Strength | BISMUTH SUBSALICYLATE | Care One (Retail Business Services, LLC.) | c443b640-18b0-4b7d-a13c-0accb915a801 | 2024-03-05 | Warnings | M008 |
| Stomach Relief - Regular Strength | BISMUTH SUBSALICYLATE | AptaPharma Inc. | 970b4118-2c2e-4806-8fe8-937ba06cf6e9 | 2023-12-30 | Warnings | M008 |
| Stomach Relief, Maximum Strength | BISMUTH SUBSALICYLATE | AptaPharma Inc. | cdd436f6-b769-49aa-9e6c-da512da9e6e3 | 2023-12-30 | Warnings | M008 |
| Stomach Relief - Maximum Strength | BISMUTH SUBSALICYLATE | AptaPharma Inc. | 15cd9163-16d6-4332-9e26-77c05e0a26a7 | 2023-12-30 | Warnings | M008 |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | Demoulas Super Markets Inc | 9a95d198-f3ba-4bc3-a6f1-e065eb7e86f0 | 2023-12-29 | Warnings | M008 |
| Stomach Relief Maximum Strength | BISMUTH SUBSALICYLATE | Demoulas Super Markets Inc | b2d55045-d4a4-4167-a20c-42932f35bab2 | 2023-12-29 | Warnings | M008 |
| STOMACH RELIEF | BISMUTH SUBSALICYLATE | Consumer Value Products, Inc. | 7526a3f2-ce7c-46c8-8ddf-1bcaf313876d | 2023-12-29 | Warnings | M008 |
| Estomaquil Polvo | BISMUTH SUBSALICYLATE | ProMex LLC | cf94c99a-c489-45ec-bb13-3e6959e377de | 2023-11-29 | Warnings | M008 |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | Care One (Retail Business Services, LLC.) | 3c53adaa-275f-4164-b21e-285e4f03433e | 2023-10-05 | Warnings | M008 |
| Pepto-Bismol Chewable, TRAVEL BASIX | BISMUTH SUBSALICYLATE | Lil' Drug Store Products, Inc. | dd2f2205-34d1-4960-bf37-bb8d534cd0e1 | 2023-10-03 | Warnings | M008 |
| Stomach Relief | BISMUTH SUBSALICYLATE | CDMA- QC | fe3cd0ce-933b-4ad3-a34f-c057a9356158 | 2021-06-16 | Warnings | M008 |
| Topcare Stomach Relief Original Strength | BISMUTH SUBSALICYLATE | TopCo Associates, LLC | e4b1929c-0967-44ea-8552-6549aa2a464e | 2018-12-14 | Warnings | M008 |
| Bismuth | BISMUTH SUBSALICYLATE | Allegiant Health | 015ca07a-f6b5-4741-a7b0-821cf6d4e418 | 2018-11-07 | Warnings | M008 |
| Gastrobiz | BISMUTH SUBSALICYLATE | Allegiant Health | aa516512-afd7-453f-9c73-5fa930cafac3 | 2018-09-11 | Warnings | M008 |
| Pep Tum | BISMUTH SUBSALICYLATE | First Aid Direct | bf966e9f-2f95-41cd-a6e5-b8eb521181d8 | 2017-12-22 | Warnings | M008 |
| Bismuth Chewable | BISMUTH SUBSALICYLATE 262 MG | Marc Glassman, Inc. | cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e | 2016-12-19 | Warnings | M008 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308762 | bismuth subsalicylate 525 MG in 30 mL Oral Suspension | PSN | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
| 211176 | Pepto-Bismol 525 MG in 30 mL Oral Suspension | PSN | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
| 211176 | bismuth subsalicylate 17.5 MG/ML Oral Suspension [Pepto-bismol] | SBD | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
| 308762 | bismuth subsalicylate 17.5 MG/ML Oral Suspension | SCD | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
| 308762 | bismuth subsalicylate 1.75 % Oral Suspension | SY | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
| 308762 | bismuth subsalicylate 262 MG per 15 ML Oral Suspension | SY | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
| 308762 | bismuth subsalicylate 524 MG per 30 ML Oral Suspension | SY | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
| 308762 | bismuth subsalicylate 525 MG per 30 ML Oral Suspension | SY | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
| 211176 | Pepto-bismol 17.5 MG/ML Oral Suspension | SY | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
| 211176 | Pepto-bismol 262 MG per 15 ML Oral Suspension | SY | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
| 211176 | Pepto-bismol 525 MG per 30 ML Oral Suspension | SY | 67006e82-870d-8d63-e053-2991aa0a02d1 | 18 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-438-04 | 37000043804 | 118 mL in 1 BOTTLE, PLASTIC (37000-438-04) | 118 ml | 2018-03-01 | 0000-00-00 | No | No | Current |
| 37000-438-08 | 37000043808 | 236 mL in 1 BOTTLE, PLASTIC (37000-438-08) | 236 ml | 2018-03-01 | 0000-00-00 | No | No | Current |
| 37000-438-12 | 37000043812 | 354 mL in 1 BOTTLE, PLASTIC (37000-438-12) | 354 ml | 2018-03-01 | 0000-00-00 | No | No | Current |
| 37000-438-16 | 37000043816 | 473 mL in 1 BOTTLE, PLASTIC (37000-438-16) | 473 ml | 2018-03-01 | 0000-00-00 | No | No | Current |
| 37000-438-24 | 37000043824 | 2 BOTTLE, PLASTIC in 1 CELLO PACK (37000-438-24) / 354 mL in 1 BOTTLE, PLASTIC | 2018-03-01 | 0000-00-00 | No | No | Current | |
| 37000-438-32 | 37000043832 | 2 BOTTLE, PLASTIC in 1 CELLO PACK (37000-438-32) / 473 mL in 1 BOTTLE, PLASTIC | 2024-06-11 | 0000-00-00 | No | No | Current | |
| 37000-438-34 | 37000043834 | 100 mL in 1 BOTTLE, PLASTIC (37000-438-34) | 100 ml | 2018-03-01 | 0000-00-00 | No | No | Current |