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 |
|---|---|---|---|---|---|---|
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | CARDINAL HEALTH 110, LLC. DBA LEADER | 7d6047a9-5557-487a-ae06-f904dac626c9 | 2025-10-14 | Warnings | M008 |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | Atlantic Biologicals Corp | 401f8393-680c-e1a8-e063-6394a90a81ab | 2025-10-01 | Warnings | M008 |
| First Aid Direct Peptum Tabs | BISMUTH SUBSALICYLATE | Cintas Corp | dd14cd57-3f7c-4634-9da9-6f83dc5bae12 | 2025-09-29 | Warnings | M008 |
| RIGHT REMEDIES Stomach Relief BISMUTH SUBSALICYLATE 262 mg softgel | BISMUTH SUBSALICYLATE | Strive Pharmaceuticals Inc. | 0f271054-fa96-4475-8279-65f4565aba36 | 2025-09-22 | Warnings | M008 |
| Bismuth Subsalicylate Suspension Regular Strength | BISMUTH SUBSALICYLATE | FSA Store Inc. (Caring Mill) | fbabc313-600a-4722-9948-1a3e21414059 | 2025-09-18 | Warnings | M008 |
| QUALITY CHOICE ULTRA STRENGTH STOMACH RELIEF | BISMUTH SUBSALICYLATE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 67c610b1-fe94-4ad3-ad1a-8bd93a4da9d9 | 2025-09-11 | Warnings | M008 |
| Medique Diotame | BISMUTH SUBSALICYLATE | Unifirst First Aid Corporation | 0667ec26-c2cd-153c-e054-00144ff88e88 | 2025-09-08 | Warnings | M008 |
| McKesson Bismuth | BISMUTH SUBSALICYLATE | McKesson Medical-Surgical | d1f3dfa4-e021-6384-e053-2995a90a7b42 | 2025-09-08 | Warnings | M008 |
| Medi-First Pep-T-Med | BISMUTH SUBSALICYLATE | Unifirst First Aid Corporation | 88f4d5d4-92ed-40ab-97a9-181da72f869b | 2025-09-08 | Warnings | M008 |
| Thompson Chewable Bismuth Tabs | BISMUTH SUBSALICYLATE | Thompson Safety LLC | c94b9bc2-b764-a9a7-e053-2a95a90aed81 | 2025-09-08 | Warnings | M008 |
| Goodsense Regular strength Stomach Relief 122 | BISMUTH SUBSALICYLATE | Preferred Pharmaceuticals Inc. | f0588ab8-d1fc-419a-8d68-bee42332d50f | 2025-08-01 | Warnings | M008 |
| Ultra Strength Stomach Relief | BISMUTH SUBSALICYLATE 525 MG | Retail Business Services, LLC. | 338ca589-91ff-30ed-e063-6294a90a243a | 2025-07-21 | Warnings | M008 |
| Regular Strength Stomach Relief | BISMUTH SUBSALICYLATE 525 MG | Retail Business Services, LLC. | 338d61af-35a8-fba7-e063-6294a90a38e8 | 2025-07-21 | Warnings | M008 |
| Senna | SENNOSIDES | Major Pharmaceuticals | cfb6bf89-c77e-4372-9bc9-44d6a659c955 | 2025-07-18 | Warnings | M008 |
| Major Bismuth Subsalicylate | BISMUTH SUBSALICYLATE | Major Pharmaceuticals | 2a7c9cc1-206e-4018-b89d-7b634df43df6 | 2025-07-11 | Warnings | M008 |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55440401-f82f-45a3-ba7e-6ccdfdacead3 | 2025-07-10 | Warnings | M008 |
| Upset Stomach Relief-Bismuth Subsalicylate 262 mg | BISMUTH SUBSALICYLATE 262 MG | Pioneer Life Sciences, LLC | 07e2cc82-ab0e-46c5-863b-67658b612678 | 2025-06-27 | Warnings | M008 |
| Upset Stomach Relief-Bismuth Subsalicylate 262 mg | BISMUTH SUBSALICYLATE 262 MG | NUVICARE LLC | 6697e464-00ac-41de-a7ea-d7bb24ed5e2a | 2025-06-25 | Warnings | M008 |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | P & L Development, LLC | 8383945f-b3a7-4242-bfaa-acf24b66406d | 2025-05-30 | Warnings | M008 |
| 5-Symptom Digestive Relief | BISMUTH SUBSALICYLATE | TARGET CORPORATION | 28fba615-48ca-8d96-e063-6394a90a2797 | 2025-04-12 | 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 |