Pepcid Complete

Manufacturer: Kenvue Brands LLC
Effective date: 2026-03-12
Label type: HUMAN OTC DRUG LABEL
Version: 25
Source: full-release
Hydrated at: 2026-06-01 01:51:29

Label at a glance#

ProductPepcid Complete

Active ingredientFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE

Label structure10 sections

Dosage and administration

adults and children 12 years and over: do not swallow tablet whole: chew completely to relieve symptoms, chew 1 tablet before swallowing do not use more than 2 chewable tablets in 24 hours children under 12 years: ask a doctor

Storage and handling

each tablet contains: calcium 320 mg, magnesium 70 mg read the directions and warnings before use read the bottle. It contains important information. store at 20°-25°C (68°-77°F) protect from moisture do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-755-4008

PhoneLabel contact215-273-8755

Websitewww.kenvuepats.com

www.kenvuepats.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each chewable tablet)	Purposes
Famotidine 10 mg	Acid reducer
Calcium carbonate 800 mg	Antacid
Magnesium hydroxide 165 mg	Antacid

Use

INDICATIONS & USAGE SECTION

relieves heartburn associated with acid indigestion and sour stomach

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to famotidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating, or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
kidney disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

your heartburn continues or worsens
you need to take this product for more than 14 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over:
- do not swallow tablet whole: chew completely
- to relieve symptoms, chew 1 tablet before swallowing
- do not use more than 2 chewable tablets in 24 hours
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

each tablet contains: calcium 320 mg, magnesium 70 mg
read the directions and warnings before use
read the bottle. It contains important information.
store at 20°-25°C (68°-77°F)
protect from moisture
do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose acetate, corn starch, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil*, modified starch, sucralose

*may contain mineral oil

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-755-4008 (toll-free) or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:

KENVUE BRANDS LLC, SUMMIT, NJ 07901

@ KENVUE BRANDS LLC 2025

Pat.www.kenvuepats.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16837-298-25

DUAL ACTION
Pepcid _®
Complete

Famotidine 10 mg–Acid reducer
Calcium carbonate 800 mg–Antacid
Magnesium hydroxide 165 mg–Antacid

Just One Tablet!

Relieves Heartburn Due to Acid Indigestion
Berry Flavor

actual size

25 Chewable Tablets

Pepcid-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
283641	famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable Tablet	PSN	25
688892	Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable Tablet	PSN	25
688892	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]	SBD	25
283641	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet	SCD	25
283641	calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet	SY	25
688892	Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable Tablet	SY	25

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FAMOTIDINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0716837291251	GTIN-13: 0716837291251 EAN-13: 0716837291251 GTIN-12: 716837291251 UPC-A: 716837291251 GTIN storage (14 digits): 00716837291251	Pepcid-1.jpg

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16837-298-12	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-12	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-12	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-25	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-25	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-25	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-50	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-50	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-50	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-65	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-65	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-65	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-67	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-67	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-67	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-68	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-68	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	Pepcid ® Complete
16837-298-68	2024-01-30	C162847	48780-1	1030e365-13a5-111a-e063-dadaa90a10e2	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	SPL version
Calcium carbonate	ACTIVE INGREDIENT	H0G9379FGK	6
Famotidine	ACTIVE INGREDIENT	5QZO15J2Z8	6
Magnesium hydroxide	ACTIVE INGREDIENT	NBZ3QY004S	6
Carbonate ion	ACTIVE MOIETY	7UJQ5OPE7D	6
Famotidine	ACTIVE MOIETY	5QZO15J2Z8	6
Hydroxide ion	ACTIVE MOIETY	9159UV381P	6
acacia	INACTIVE INGREDIENT	5C5403N26O	6
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	6
cellulose acetate	INACTIVE INGREDIENT	3J2P07GVB6	6
crospovidone	INACTIVE INGREDIENT	68401960MK	6
D&C red no. 7	INACTIVE INGREDIENT	ECW0LZ41X8	6
dextrose	INACTIVE INGREDIENT	IY9XDZ35W2	6
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	6
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	6
hydroxypropyl cellulose (type e)	INACTIVE INGREDIENT	66O7AQV0RT	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	6
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	6
maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	6
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	6
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	6
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

Pepcid Complete
Famotidine, Calcium carbonate, and Magnesium hydroxide
STARCH, CORN
CELLULOSE ACETATE
CROSPOVIDONE
DEXTROSE, UNSPECIFIED FORM
FD&C BLUE NO. 1 ALUMINUM LAKE
ALUMINUM OXIDE
FD&C RED NO. 40
D&C RED NO. 7
ACACIA
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALTODEXTRIN
MINERAL OIL
SUCRALOSE
FAMOTIDINE
CALCIUM CARBONATE
CARBONATE ION
MAGNESIUM HYDROXIDE
HYDROXIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16837-298	16837-298-12, 16837-298-25, 16837-298-50, 16837-298-65, 16837-298-67, 16837-298-68, 16837-298-70, 16837-298-52, 16837-298-72

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STARCH, CORN	O8232NY3SJ	IACT
CELLULOSE ACETATE	3J2P07GVB6	IACT
CROSPOVIDONE	2S7830E561	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
D&C RED NO. 7	ECW0LZ41X8	IACT
ACACIA	5C5403N26O	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MINERAL OIL	T5L8T28FGP	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
FAMOTIDINE	5QZO15J2Z8	ACTIB
CALCIUM CARBONATE	H0G9379FGK	ACTIB
MAGNESIUM HYDROXIDE	NBZ3QY004S	ACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
24	2025-11-05	monthly-update	2026-06-03 17:39:40
23	2025-08-07	full-release	2026-06-01 01:10:15

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 430 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route 220 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
dextrose	DEXTROSE	IY9XDZ35W2	TABLET, CHEWABLE / ORAL		1286 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii+route 220 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 220 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 220 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route 220 equally ranked IID candidates
dextrose	DEXTROSE	IY9XDZ35W2	TABLET, CHEWABLE / ORAL		1286 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
hydroxypropyl cellulose (type e)	HYDROXYPROPYL CELLULOSE (70000 WAMW)	66O7AQV0RT	TABLET, FILM COATED / ORAL		15 mg	Exact identifier — unii+route 30 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
D&C red no. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 60 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii+route 220 equally ranked IID candidates
D&C red no. 7	D&C RED NO. 7	ECW0LZ41X8	CAPSULE / ORAL	NA		Exact identifier — unii+route 60 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 220 equally ranked IID candidates
D&C red no. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 60 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 220 equally ranked IID candidates
cellulose acetate	CELLULOSE ACETATE	3J2P07GVB6	TABLET, CHEWABLE / ORAL		27 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route 220 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 220 equally ranked IID candidates
D&C red no. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 60 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route 220 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
D&C red no. 7	D&C RED NO. 7	ECW0LZ41X8	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route 60 equally ranked IID candidates
dextrose	DEXTROSE	IY9XDZ35W2	TABLET, CHEWABLE / ORAL		1286 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
hydroxypropyl cellulose (type e)	HYDROXYPROPYL CELLULOSE (70000 WAMW)	66O7AQV0RT	TABLET, FILM COATED / ORAL		15 mg	Exact identifier — unii+route 30 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii+route 220 equally ranked IID candidates
acacia	ACACIA	5C5403N26O	TABLET, CHEWABLE / ORAL		121 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii+route 220 equally ranked IID candidates
D&C red no. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET / ORAL	0.5 mg		Exact identifier — unii+route 60 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route 220 equally ranked IID candidates
cellulose acetate	CELLULOSE ACETATE	3J2P07GVB6	TABLET, CHEWABLE / ORAL		27 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
D&C red no. 7	D&C RED NO. 7	ECW0LZ41X8	CAPSULE / ORAL	NA		Exact identifier — unii+route 60 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii+route 220 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii+route 220 equally ranked IID candidates
D&C red no. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET / ORAL	0.5 mg		Exact identifier — unii+route 60 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`84e616aacf4f…`
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…`

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…`

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 · 1 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	e874118f-b4fe-4c80-aece-99ea20e7e805	2026-03-12	Warnings	Exact identifier ndc (package): 16837-298-12 ndc (package): 16837-298-72 ndc (package): 16837-298-67 ndc (package): 16837-298-52 ndc (package): 16837-298-65 ndc (package): 16837-298-25 ndc (package): 16837-298-50 ndc (package): 16837-298-68 ndc (package): 16837-298-70 ndc (product): 16837-298 ndc11 (package): 16837029825 ndc11 (package): 16837029865 ndc11 (package): 16837029850 ndc11 (package): 16837029868 ndc11 (package): 16837029870 ndc11 (package): 16837029867 ndc11 (package): 16837029872 ndc11 (package): 16837029812 ndc11 (package): 16837029852 spl id: 4cd2ca51-2077-9389-e063-6394a90a40e2 spl set id: e874118f-b4fe-4c80-aece-99ea20e7e805

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.