Pepto
- Product NDC
- 37000-446
- 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
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 | 37000-446 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 37000-446 | 37000-446-72 | D | Discontinued by firm | 2026-10-15 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 37000-446-72 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 37000-446-72 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 37000-446-72 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 37000-446-72 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 37000-446-72 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 37000-446-72 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 37000-446-72 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 37000-446-72 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 37000-446-72 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 37000-446-72 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 37000-446-72 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 37000-446-72 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|
| 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 | 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 |