Pepcid Complete
- Product NDC
- 16837-246
- 11-digit product format
- 168370246
- Labeler code
- 16837
- Product ID
- 16837-246_42d92ca2-a860-6e60-e063-6294a90af5b5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine, Calcium Carbonate, and Magnesium Hydroxide
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA020958
- Marketing category
- NDA
- Marketing start
- 2009-01-01
- Substance
- CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
- Active strength
- 800; 10; 165 mg/1; mg/1; mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 package | package | 16837-246 | 16837-246-05 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 16837-246 | 16837-246-08 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 16837-246 | 16837-246-26 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 16837-246 | 16837-246-27 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 16837-246 | 16837-246-28 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 16837-246 | 16837-246-29 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 16837-246 | 16837-246-36 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 16837-246 | 16837-246-64 | D | Discontinued by firm | 2026-08-17 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 16837-246-36 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 16837-246-26 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 16837-246-29 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 16837-246-27 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 16837-246-08 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 16837-246-64 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 16837-246-28 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 16837-246-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 16837-246-08 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 16837-246-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 16837-246-05 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 16837-246-27 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 16837-246-64 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 16837-246-29 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 16837-246-28 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 16837-246-36 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 16837-246-26 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 16837-246-08 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 16837-246-28 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 16837-246-27 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 16837-246-36 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 16837-246-05 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 16837-246-64 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 16837-246-29 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 16837-246-26 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 16837-246-08 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 16837-246-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 16837-246-27 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 16837-246-36 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 16837-246-05 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 16837-246-64 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 16837-246-29 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 16837-246-26 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 16837-246-08 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 16837-246-28 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 16837-246-27 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 16837-246-36 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 16837-246-05 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 16837-246-64 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 16837-246-29 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 16837-246-26 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 16837-246-08 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 16837-246-28 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 16837-246-27 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 16837-246-36 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 16837-246-05 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 16837-246-64 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 16837-246-29 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 16837-246-26 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 16837-246-08 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 16837-246-28 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 16837-246-27 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 16837-246-36 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 16837-246-05 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 16837-246-64 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 16837-246-29 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 16837-246-26 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 16837-246-08 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 16837-246-28 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 16837-246-27 | ed331223b511… | 672a5bd82f5f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020958-001 | PEPCID COMPLETE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020958-001 | PEPCID COMPLETE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | RLD, RS | 2000-10-16 | e64feba35796… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020958-001 | 6814978 | 2021-08-26 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020958-001 | 6814978 | 2021-08-26 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020958-001 | 6814978 | 2021-08-26 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020958-001 | 6814978 | 2021-08-26 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020958-001 | 6814978 | 2021-08-26 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020958-001 | 6814978 | 2021-08-26 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020958-001 | 6814978 | 2021-08-26 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020958-001 | 6814978 | 2021-08-26 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020958-001 | 6814978 | 2021-08-26 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | ea99ee380514… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020958-001 | 6814978*PED | 2022-02-26 | Pediatric extension | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pepcid Complete
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FAMOTIDINE | 800 mg/1 |
| CALCIUM CARBONATE | 10 mg/1 |
| MAGNESIUM HYDROXIDE | 165 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5QZO15J2Z8 | Internal UNII lookup |
| H0G9379FGK | Internal UNII lookup |
| NBZ3QY004S | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 37e6a3f6-5261-475d-a7d4-e72854088982 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae | Product name | 7 | 20260317 |
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| cf645750-2e70-f6e1-c05a-a52847def5dd | Product name | 9 | 20250312 |
| 4fdc761c-585e-054b-8ebe-86130a26e4c1 | Product name | 2 | 20221205 |
| fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16837-246-05 | Pepcid Complete | 1 in 1 POUCH | TABLET, CHEWABLE | 1 | 15 | |
| 16837-246-05 | Pepcid Complete | 5 in 1 CARTON | TABLET, CHEWABLE | 5 | 15 | |
| 16837-246-08 | Pepcid Complete | 8 in 1 CARTON | TABLET, CHEWABLE | 8 | 15 | |
| 16837-246-08 | Pepcid Complete | 1 in 1 POUCH | TABLET, CHEWABLE | 1 | 15 | |
| 16837-246-25 | Pepcid Complete | 25 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 25 | 15 | |
| 16837-246-26 | Pepcid Complete | 25 in 1 TRAY | TABLET, CHEWABLE | 25 | 15 | |
| 16837-246-26 | Pepcid Complete | 1 in 1 POUCH | TABLET, CHEWABLE | 1 | 15 | |
| 16837-246-27 | Pepcid Complete | 2500 in 1 TRAY | TABLET, CHEWABLE | 2500 | 15 | |
| 16837-246-27 | Pepcid Complete | 1 in 1 POUCH | TABLET, CHEWABLE | 1 | 15 | |
| 16837-246-28 | Pepcid Complete | 2500 in 1 TRAY | TABLET, CHEWABLE | 2500 | 15 | |
| 16837-246-28 | Pepcid Complete | 1 in 1 POUCH | TABLET, CHEWABLE | 1 | 15 | |
| 16837-246-29 | Pepcid Complete | 1 in 1 POUCH | TABLET, CHEWABLE | 1 | 15 | |
| 16837-246-29 | Pepcid Complete | 25 in 1 TRAY | TABLET, CHEWABLE | 25 | 15 | |
| 16837-246-36 | Pepcid Complete | 35 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 35 | 15 | |
| 16837-246-36 | Pepcid Complete | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | 15 | |
| 16837-246-50 | Pepcid Complete | 50 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 50 | 15 | |
| 16837-246-64 | Pepcid Complete | 65 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 65 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16837-246-25 | EA - Each | 16837-246 | aec25d71-9316-41f3-a4be-d5b0383d1ec0 | 1 | 2018-10-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 16837-246 | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC] | 13 | Current NDC, Legacy NDC, 17 package rows | 20241114_37e6a3f6-5261-475d-a7d4-e72854088982.zip |
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 |
|---|---|---|---|---|---|---|
| Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | Kenvue Brands LLC | a2ef8424-7d80-42b0-a01e-f378f629b2b6 | 2026-07-24 | Warnings | 020958 NDA020958 |
| Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | Select Consumer Group | 55cc3304-9094-3da8-e063-6394a90aa49b | 2026-07-04 | Warnings | 020958 NDA020958 |
| Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | Savings Distributors LLC | 549136d5-8f2c-d417-e063-6394a90a23e4 | 2026-06-01 | Warnings | 020958 NDA020958 |
| Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | Kenvue Brands LLC | e874118f-b4fe-4c80-aece-99ea20e7e805 | 2026-03-12 | Warnings | 020958 NDA020958 |
| Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | R J General Corporation | f0e08608-e9b0-3203-e053-2995a90adfbd | 2025-11-17 | Warnings | 020958 NDA020958 |
| Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | Kenvue Brands LLC | 37e6a3f6-5261-475d-a7d4-e72854088982 | 2025-11-05 | Warnings | 020958 NDA020958 16837-246 |
| Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | Morning Star OTC | be7f97d5-d2f2-45a8-96b4-fed1549ae2a3 | 2025-06-19 | Warnings | 020958 NDA020958 |
| Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | JC World Bell Wholesale Co., Inc. | 39f7ee67-4eab-42b0-82fc-40dc8ce7666b | 2024-12-31 | Warnings | 020958 NDA020958 |
| DUAL ACTION Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE TABLET, CHEWABLE | Lil' Drug Store Products, Inc. | f3cf2e19-1348-0eac-e053-2a95a90a46c1 | 2024-12-30 | Warnings | 020958 NDA020958 |
| Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | Navajo Manufacturing Company Inc | ac3cd760-4615-117b-e053-2a95a90a8d42 | 2024-04-15 | Warnings | 020958 NDA020958 |
| Pepcid Complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE CHEWABLE TABLET | Lil' Drug Store Products, Inc. | d08984b8-ce03-9e95-e053-2995a90ae6f0 | 2024-01-25 | Warnings | 020958 NDA020958 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283641 | famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable Tablet | PSN | 37e6a3f6-5261-475d-a7d4-e72854088982 | 15 |
| 688892 | Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable Tablet | PSN | 37e6a3f6-5261-475d-a7d4-e72854088982 | 15 |
| 688892 | calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete] | SBD | 37e6a3f6-5261-475d-a7d4-e72854088982 | 15 |
| 283641 | calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet | SCD | 37e6a3f6-5261-475d-a7d4-e72854088982 | 15 |
| 283641 | calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet | SY | 37e6a3f6-5261-475d-a7d4-e72854088982 | 15 |
| 688892 | Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable Tablet | SY | 37e6a3f6-5261-475d-a7d4-e72854088982 | 15 |
| 283641 | famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable Tablet | PSN | 7f1903e6-e014-4a6e-86e1-38339f893ede | 1 |
| 688892 | Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable Tablet | PSN | 7f1903e6-e014-4a6e-86e1-38339f893ede | 1 |
| 688892 | calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete] | SBD | 7f1903e6-e014-4a6e-86e1-38339f893ede | 1 |
| 283641 | calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet | SCD | 7f1903e6-e014-4a6e-86e1-38339f893ede | 1 |
| 283641 | calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet | SY | 7f1903e6-e014-4a6e-86e1-38339f893ede | 1 |
| 688892 | Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable Tablet | SY | 7f1903e6-e014-4a6e-86e1-38339f893ede | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16837-246-05 | 16837024605 | 1 in 1 POUCH | Historical | ||||
| 16837-246-08 | 16837024608 | 8 in 1 CARTON | Historical | ||||
| 16837-246-25 | 16837024625 | 25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-25) | 2009-01-01 | 0000-00-00 | No | No | Current |
| 16837-246-26 | 16837024626 | 25 in 1 TRAY | Historical | ||||
| 16837-246-27 | 16837024627 | 2500 in 1 TRAY | Historical | ||||
| 16837-246-28 | 16837024628 | 2500 in 1 TRAY | Historical | ||||
| 16837-246-29 | 16837024629 | 1 in 1 POUCH | Historical | ||||
| 16837-246-36 | 16837024636 | 35 in 1 BOTTLE, PLASTIC | Historical | ||||
| 16837-246-50 | 16837024650 | 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50) | 2009-01-01 | 0000-00-00 | No | No | Current |
| 16837-246-64 | 16837024664 | 65 in 1 BOTTLE, PLASTIC | Historical |