Pepcid Complete

Product NDC: 52904-948
11-digit product format: 529040948
Labeler code: 52904
Product ID: 52904-948_fba25037-8f64-4e0d-b2bd-cc1f307c01c6
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine, Calcium Carbonate, and Magnesium Hydroxide
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Select Corporation
Application: NDA020958
Marketing category: NDA
Marketing start: 2009-01-01
Marketing end: 0000-00-00
Substance: CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Active strength: 800 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: 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.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52904-948		I	Inactivated by FDA	2026-08-17
excluded package	package	52904-948	52904-948-03	I	Inactivated by FDA	2026-08-17
excluded package	package	52904-948	52904-948-07	I	Inactivated by FDA	2026-08-17
excluded package	package	52904-948	52904-948-20	I	Inactivated by FDA	2026-08-17
excluded package	package	52904-948	52904-948-25	I	Inactivated by FDA	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.

Historic NDC status page 1 of 2 · 75 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
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	52904-948-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52904-948-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52904-948-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52904-948-25	`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	52904-948-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52904-948-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52904-948-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52904-948-25	`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	52904-948-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52904-948-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52904-948-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52904-948-25	`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	52904-948-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52904-948-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52904-948-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52904-948-25	`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	52904-948-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52904-948-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52904-948-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52904-948-25	`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	52904-948-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52904-948-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52904-948-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52904-948-25	`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	52904-948-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52904-948-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52904-948-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52904-948-25	`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	52904-948-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52904-948-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52904-948-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52904-948-25	`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	52904-948-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52904-948-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52904-948-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52904-948-25	`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	52904-948-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52904-948-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52904-948-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52904-948-25	`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	52904-948-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52904-948-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52904-948-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52904-948-25	`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	52904-948-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52904-948-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52904-948-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52904-948-25	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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 table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
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#

NDC, Related label table
NDC	Related label
52904-948-03	Pepcid ® Complete ®
52904-948-07	Pepcid ® Complete ®
52904-948-20	Pepcid ® Complete ®
52904-948-25	Pepcid ® Complete ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52904-948-03	Pepcid Complete	1 in 1 POUCH	TABLET, CHEWABLE	1	1
52904-948-03	Pepcid Complete	1 in 1 BLISTER PACK	TABLET, CHEWABLE	1	1
52904-948-07	Pepcid Complete	1 in 1 POUCH	TABLET, CHEWABLE	1	1
52904-948-07	Pepcid Complete	2 in 1 BLISTER PACK	TABLET, CHEWABLE	2	1
52904-948-20	Pepcid Complete	20 in 1 CARTON	TABLET, CHEWABLE	20	1
52904-948-20	Pepcid Complete	1 in 1 POUCH	TABLET, CHEWABLE	1	1
52904-948-25	Pepcid Complete	25 in 1 CARTON	TABLET, CHEWABLE	25	1
52904-948-25	Pepcid Complete	1 in 1 POUCH	TABLET, CHEWABLE	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52904-948	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SELECT CORPORATION]	1	Legacy NDC, 8 package rows	20220423_7f1903e6-e014-4a6e-86e1-38339f893ede.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.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Select Consumer Group	55cc3304-9094-3da8-e063-6394a90aa49b	2026-07-04	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Savings Distributors LLC	549136d5-8f2c-d417-e063-6394a90a23e4	2026-06-01	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Kenvue Brands LLC	e874118f-b4fe-4c80-aece-99ea20e7e805	2026-03-12	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	R J General Corporation	f0e08608-e9b0-3203-e053-2995a90adfbd	2025-11-17	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Kenvue Brands LLC	37e6a3f6-5261-475d-a7d4-e72854088982	2025-11-05	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Morning Star OTC	be7f97d5-d2f2-45a8-96b4-fed1549ae2a3	2025-06-19	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	JC World Bell Wholesale Co., Inc.	39f7ee67-4eab-42b0-82fc-40dc8ce7666b	2024-12-31	Warnings	Exact identifier application applno (NDA): 020958 application number: 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	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Navajo Manufacturing Company Inc	ac3cd760-4615-117b-e053-2a95a90a8d42	2024-04-15	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE CHEWABLE TABLET	Lil' Drug Store Products, Inc.	d08984b8-ce03-9e95-e053-2995a90ae6f0	2024-01-25	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0G9379FGK	CALCIUM CARBONATE	471-34-1	CALCIUM CARBONATE
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE
NBZ3QY004S	MAGNESIUM HYDROXIDE	1309-42-8	MAGNESIUM HYDROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
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 table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52904-948-03	52904094803	1 POUCH in 1 BLISTER PACK (52904-948-03) > 1 TABLET, CHEWABLE in 1 POUCH	1 pouch	2009-01-01	0000-00-00	No	No	Current
52904-948-07	52904094807	2 POUCH in 1 BLISTER PACK (52904-948-07) > 1 TABLET, CHEWABLE in 1 POUCH	2 pouch	2009-01-01	0000-00-00	No	No	Current
52904-948-20	52904094820	20 POUCH in 1 CARTON (52904-948-20) > 1 TABLET, CHEWABLE in 1 POUCH	20 pouch	2009-01-01	0000-00-00	No	No	Current
52904-948-25	52904094825	25 POUCH in 1 CARTON (52904-948-25) > 1 TABLET, CHEWABLE in 1 POUCH	25 pouch	2009-01-01	0000-00-00	No	No	Current