Pepcid Complete

Product NDC: 16837-298
11-digit product format: 168370298
Labeler code: 16837
Product ID: 16837-298_4cd2ca51-2077-9389-e063-6394a90a40e2
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: 2009-03-01
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: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pepcid Complete
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	800 mg/1
CALCIUM CARBONATE	10 mg/1
MAGNESIUM HYDROXIDE	165 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5QZO15J2Z8	Internal UNII lookup
H0G9379FGK	Internal UNII lookup
NBZ3QY004S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283641	Internal RxNorm lookup
688892	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e874118f-b4fe-4c80-aece-99ea20e7e805	Available on FDA.report

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
16837-298-12	Pepcid ® Complete
16837-298-12	Pepcid ® Complete
16837-298-12	Pepcid ® Complete
16837-298-25	Pepcid ® Complete
16837-298-25	Pepcid ® Complete
16837-298-25	Pepcid ® Complete
16837-298-50	Pepcid ® Complete
16837-298-50	Pepcid ® Complete
16837-298-50	Pepcid ® Complete
16837-298-65	Pepcid ® Complete
16837-298-65	Pepcid ® Complete
16837-298-65	Pepcid ® Complete
16837-298-67	Pepcid ® Complete
16837-298-67	Pepcid ® Complete
16837-298-67	Pepcid ® Complete
16837-298-68	Pepcid ® Complete
16837-298-68	Pepcid ® Complete
16837-298-68	Pepcid ® Complete

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16837-298-12	Pepcid Complete	100 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	100	25
16837-298-25	Pepcid Complete	25 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	25	25
16837-298-50	Pepcid Complete	50 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	50	25
16837-298-52	Pepcid Complete	50 in 1 CARTON	TABLET, CHEWABLE	50	25
16837-298-52	Pepcid Complete	1 in 1 POUCH	TABLET, CHEWABLE	1	25
16837-298-65	Pepcid Complete	2500 in 1 CARTON	TABLET, CHEWABLE	2500	25
16837-298-65	Pepcid Complete	1 in 1 POUCH	TABLET, CHEWABLE	1	25
16837-298-67	Pepcid Complete	4 in 1 CARTON	TABLET, CHEWABLE	4	25
16837-298-67	Pepcid Complete	1 in 1 POUCH	TABLET, CHEWABLE	1	25
16837-298-68	Pepcid Complete	8 in 1 CARTON	TABLET, CHEWABLE	8	25
16837-298-68	Pepcid Complete	1 in 1 POUCH	TABLET, CHEWABLE	1	25
16837-298-70	Pepcid Complete	70 in 1 BOTTLE	TABLET, CHEWABLE	70	25
16837-298-72	Pepcid Complete	72 in 1 BOTTLE	TABLET, CHEWABLE	72	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16837-298-12	EA - Each	16837-298	b28a5dfd-c87e-4030-a0dd-726de9512955	1	2024-04-05
16837-298-50	EA - Each	16837-298	6b3ffd42-8c8a-40bf-aa54-5498011fa915	1	2025-01-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Calcium carbonate	ACTIVE INGREDIENT	H0G9379FGK	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
Famotidine	ACTIVE INGREDIENT	5QZO15J2Z8	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
Magnesium hydroxide	ACTIVE INGREDIENT	NBZ3QY004S	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
Carbonate ion	ACTIVE MOIETY	7UJQ5OPE7D	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
Famotidine	ACTIVE MOIETY	5QZO15J2Z8	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
Hydroxide ion	ACTIVE MOIETY	9159UV381P	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
acacia	INACTIVE INGREDIENT	5C5403N26O	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
cellulose acetate	INACTIVE INGREDIENT	3J2P07GVB6	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
crospovidone	INACTIVE INGREDIENT	68401960MK	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
D&C red no. 7	INACTIVE INGREDIENT	ECW0LZ41X8	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
dextrose	INACTIVE INGREDIENT	IY9XDZ35W2	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
hydroxypropyl cellulose (type e)	INACTIVE INGREDIENT	66O7AQV0RT	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16837-298	PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]	21	Current NDC, Legacy NDC, 13 package rows	20241114_e874118f-b4fe-4c80-aece-99ea20e7e805.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 ndc (product): 16837-298
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	e874118f-b4fe-4c80-aece-99ea20e7e805	25
688892	Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable Tablet	PSN	e874118f-b4fe-4c80-aece-99ea20e7e805	25
688892	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]	SBD	e874118f-b4fe-4c80-aece-99ea20e7e805	25
283641	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet	SCD	e874118f-b4fe-4c80-aece-99ea20e7e805	25
283641	calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet	SY	e874118f-b4fe-4c80-aece-99ea20e7e805	25
688892	Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable Tablet	SY	e874118f-b4fe-4c80-aece-99ea20e7e805	25
283641	famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable Tablet	PSN	39f7ee67-4eab-42b0-82fc-40dc8ce7666b	4
283641	famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable Tablet	PSN	f0e08608-e9b0-3203-e053-2995a90adfbd	4
688892	Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable Tablet	PSN	39f7ee67-4eab-42b0-82fc-40dc8ce7666b	4
688892	Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable Tablet	PSN	f0e08608-e9b0-3203-e053-2995a90adfbd	4
688892	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]	SBD	39f7ee67-4eab-42b0-82fc-40dc8ce7666b	4
688892	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]	SBD	f0e08608-e9b0-3203-e053-2995a90adfbd	4
283641	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet	SCD	39f7ee67-4eab-42b0-82fc-40dc8ce7666b	4
283641	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet	SCD	f0e08608-e9b0-3203-e053-2995a90adfbd	4
283641	calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet	SY	f0e08608-e9b0-3203-e053-2995a90adfbd	4
283641	calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet	SY	39f7ee67-4eab-42b0-82fc-40dc8ce7666b	4
688892	Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable Tablet	SY	39f7ee67-4eab-42b0-82fc-40dc8ce7666b	4
688892	Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable Tablet	SY	f0e08608-e9b0-3203-e053-2995a90adfbd	4
283641	famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable Tablet	PSN	ac3cd760-4615-117b-e053-2a95a90a8d42	2
688892	Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable Tablet	PSN	ac3cd760-4615-117b-e053-2a95a90a8d42	2
688892	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]	SBD	ac3cd760-4615-117b-e053-2a95a90a8d42	2
283641	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet	SCD	ac3cd760-4615-117b-e053-2a95a90a8d42	2
283641	calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet	SY	ac3cd760-4615-117b-e053-2a95a90a8d42	2
688892	Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable Tablet	SY	ac3cd760-4615-117b-e053-2a95a90a8d42	2
283641	famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable Tablet	PSN	be7f97d5-d2f2-45a8-96b4-fed1549ae2a3	1
688892	Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable Tablet	PSN	be7f97d5-d2f2-45a8-96b4-fed1549ae2a3	1
688892	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]	SBD	be7f97d5-d2f2-45a8-96b4-fed1549ae2a3	1
283641	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet	SCD	be7f97d5-d2f2-45a8-96b4-fed1549ae2a3	1
283641	calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet	SY	be7f97d5-d2f2-45a8-96b4-fed1549ae2a3	1
688892	Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable Tablet	SY	be7f97d5-d2f2-45a8-96b4-fed1549ae2a3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16837-298-12	16837029812	100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-12)		2009-03-01	0000-00-00	No	No	Current
16837-298-25	16837029825	25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-25)		2009-03-01	0000-00-00	No	No	Current
16837-298-50	16837029850	50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-50)		2009-03-01	0000-00-00	No	No	Current
16837-298-52	16837029852	50 POUCH in 1 CARTON (16837-298-52) / 1 TABLET, CHEWABLE in 1 POUCH	50 pouch	2025-10-31		No	No	Current
16837-298-65	16837029865	2500 POUCH in 1 CARTON (16837-298-65) / 1 TABLET, CHEWABLE in 1 POUCH	2500 pouch	2020-06-15	0000-00-00	No	No	Current
16837-298-67	16837029867	4 POUCH in 1 CARTON (16837-298-67) / 1 TABLET, CHEWABLE in 1 POUCH	4 pouch	2020-06-15	0000-00-00	No	No	Current
16837-298-68	16837029868	8 POUCH in 1 CARTON (16837-298-68) / 1 TABLET, CHEWABLE in 1 POUCH	8 pouch	2020-06-15	0000-00-00	No	No	Current
16837-298-70	16837029870	70 TABLET, CHEWABLE in 1 BOTTLE (16837-298-70)		2025-08-29		No	No	Current
16837-298-72	16837029872	72 TABLET, CHEWABLE in 1 BOTTLE (16837-298-72)		2026-05-29		0		Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pepcid ® Complete	Select Consumer Group	2026-07-04	HUMAN OTC DRUG LABEL	1
Pepcid ® Complete	Savings Distributors LLC	2026-06-01	HUMAN OTC DRUG LABEL	1
Pepcid ® Complete	Kenvue Brands LLC	2026-03-12	HUMAN OTC DRUG LABEL	25
Pepcid Complete	R J General Corporation	2025-11-17	HUMAN OTC DRUG LABEL	4
Pepcid ® Complete	Morning Star OTC	2025-06-19	HUMAN OTC DRUG LABEL	1
Pepcid Complete	JC World Bell Wholesale Co., Inc. \| Kenvue Brands LLC	2024-12-31	HUMAN OTC DRUG LABEL	4
Pepcid Complete	Navajo Manufacturing Company Inc \| Navajo Manufacturing Company Inc.	2024-04-15	HUMAN OTC DRUG LABEL	2