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 | 2026-10-12 | ||
| excluded package | package | 37000-446 | 37000-446-72 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|
| Kaopectate | BISMUTH SUBSALICYLATE | Kramer Laboratories | 3877a88d-9546-48ce-ad6b-3c2a115e3eaf | 2026-06-03 | Warnings | M008 |
| Bismuth Subsalicylate Suspension Regular Strength | BISMUTH SUBSALICYLATE | AptaPharma Inc. | f0976d6c-d574-49e8-b98a-23a660d83fa0 | 2026-06-02 | Warnings | M008 |
| Stomach Relief Maximum Strength | BISMUTH SUBSALICYLATE | CVS Pharmacy | 9d8f2456-732d-40bf-a10c-98423560c029 | 2026-05-13 | Warnings | M008 |
| Green Guard Instydose Upset Stomach Relief | BISMUTH SUBSALICYLATE | Unifirst First Aid Corporation | 5b1f31a9-8eec-4c3d-e063-6394a90a2efe | 2026-05-01 | Warnings | M008 |
| Stomach Relief Ultra | BISMUTH SUBSALICYLATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 6f189c12-eb94-476e-a8f7-ea82f44c4aa5 | 2026-04-13 | Warnings | M008 |
| Pepto Bismol | BISMUTH SUBSALICYLATE | Navajo Manufacturing Company Inc. | 033bccc6-6e81-487f-91fe-9d7cc465e1b2 | 2026-04-08 | Warnings | M008 |
| Soothe | BISMUTH SUBSALICYLATE | Walgreens | 450483c3-487f-4a8f-a439-5661241a8f0f | 2026-04-08 | Warnings | M008 |
| GS Stomach Relief | BISMUTH SUBSALICYLATE 525 MG | Good Sense (Geiss, Destin & Dunn, Inc.) | edd15c7d-f66b-4b1a-8cda-9814a3790483 | 2026-03-31 | Warnings | M008 |
| WALGREEN ULTRA STRENGTH PINK BISMUTH | BISMUTH SUBSALICYLATE | WALGREENS CO. | d0f78754-2556-4aa8-949b-a6e3b4adf8c2 | 2026-03-25 | Warnings | M008 |
| Dr. Simi Stomach Relief | BISMUTH SUBSALICYLATE 525 MG | Farmacias De Similares TX LLC | 4dc9233e-68fb-e1e8-e063-6294a90aee33 | 2026-03-24 | Warnings | M008 |
| Major Bismuth Subsalicylate | BISMUTH SUBSALICYLATE | Preferred Pharmaceuticals Inc. | 69b9999f-c2e5-43a6-891f-0e24d3c343a4 | 2026-03-20 | Warnings | M008 |
| Stomach Relief | BISMUTH SUBSALICYLATE | Grocery Outlet, Inc. | 4465dd17-c333-7b95-e063-6294a90a5053 | 2026-03-19 | Warnings | M008 |
| AMAZON Regular Strength | BISMUTH SUBSALICYLATE | AMAZON.COM SERVICES LLC | 6b41f36d-1810-45f7-a46c-67b9bff23738 | 2026-03-04 | Warnings | M008 |
| AMAZON Digestive Relief | BISMUTH SUBSALICYLATE | AMAZON.COM SERVICES LLC | a9a676d8-06b9-43bf-9c06-08670c9ab211 | 2026-03-04 | Warnings | M008 |
| Stomach Relief | BISMUTH SUBSALICYLATE | Wal-Mart Stores Inc | 2d7d563e-4c46-4788-b6a7-5b92e3d58533 | 2026-02-26 | Warnings | M008 |
| Stomach Relief | BISMUTH SUBSALICYLATE | Chain Drug Marketing Association, Inc. | d63110ee-2d64-46dd-80bf-696c9b9d8d7c | 2026-02-26 | Warnings | M008 |
| SIGNATURE CARE Ultra Strength Stomach | BISMUTH SUBSALICYLATE | SAFEWAY | 4b54fa21-d8ea-4497-aa32-17e47669c8e1 | 2026-02-20 | Warnings | M008 |
| SIGNATURE CARE Regular Strength | BISMUTH SUBSALICYLATE | SAFEWAY | b4643d99-90ce-4f00-a61a-a5371fe0f424 | 2026-02-20 | Warnings | M008 |
| Stomach Relief | BISMUTH SUBSALICYLATE | Grocery Outlet, Inc. | 44673b4f-1bf8-9db3-e063-6294a90a62f5 | 2026-02-14 | Warnings | M008 |
| Treda Ultra | BISMUTH SUBSALICYLATE | Laboratorios Sanfer, S.A. de C.V. | cfa7f37a-e18b-4929-b3a4-4126b0aa679a | 2026-02-12 | 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 |