Pepto
- Product NDC
- 37000-446
- Requested package NDC
- 37000-446-24
- 11-digit product format
- 370000446
- Labeler code
- 37000
- Product ID
- 37000-446_e4ce53fa-bdef-2da1-e053-2a95a90aabe4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calcium Carbonate
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M008
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2005-07-20
- Marketing end
- 0000-00-00
- Substance
- CALCIUM CARBONATE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37000-446-24 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-3792-a910-e053-dadaa90a0b85 | Pepto ® Kids Chewable Tablets |
| 37000-446-24 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3792-a910-e053-dadaa90a0b85 | Pepto ® Kids Chewable Tablets |
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 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 37000-446-24 | 37000044624 | 1 BOTTLE, PLASTIC in 1 CARTON (37000-446-24) > 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC | 2018-01-21 | 0000-00-00 | No | No | Current |