PEPCID AC

Manufacturer: Kenvue Brands LLC
Effective date: 2024-11-11
Label type: HUMAN OTC DRUG LABEL
Version: 23
Source: full-release
Hydrated at: 2026-06-01 00:36:47

Label at a glance#

ProductPEPCID AC Maximum Strength

Active ingredientFAMOTIDINE

Label structure10 sections

Indications and uses

relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Dosage and administration

adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

Storage and handling

read the directions and warnings before use keep the carton. It contains important information. store at 20°-25°C (68°-77°F) protect from moisture

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-755-4008

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

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. 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:
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
- do not use more than 2 tablets in 24 hours
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

read the directions and warnings before use
keep the carton. It contains important information.
store at 20°-25°C (68°-77°F)
protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16837-855-14

MAXIMUM STRENGTH

Pepcid _®

AC

Famotidine Tablets 20 mg

Acid Reducer

Just One Tablet!

Prevents & Relieves Heartburn

Due to Acid Indigestion

actual size

25 Tablets

Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	23
104094	Pepcid AC 20 MG Oral Tablet	PSN	23
104094	famotidine 20 MG Oral Tablet [Pepcid]	SBD	23
310273	famotidine 20 MG Oral Tablet	SCD	23
104094	Pepcid 20 MG Oral Tablet	SY	23
104094	Pepcid AC 20 MG Oral Tablet	SY	23

DailyMed Pharmacologic Classes#

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

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
16837-855-02	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-05	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-09	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-12	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-13	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-14	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-15	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-16	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-17	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-18	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-19	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-20	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-24	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-25	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-40	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-49	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-50	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-51	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-52	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-65	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-67	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-70	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-75	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-80	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-85	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength
16837-855-90	2024-01-30	C162847	48780-1	1030e365-2b49-111a-e063-dadaa90a10e2	PEPCID ® AC Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16837-855-02	PEPCID ACMaximum Strength	2 in 1 CARTON	TABLET, FILM COATED	2	23
16837-855-02	PEPCID ACMaximum Strength	1 in 1 POUCH	TABLET, FILM COATED	1	23
16837-855-05	PEPCID ACMaximum Strength	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	23
16837-855-05	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-09	PEPCID ACMaximum Strength	1 in 1 PACKAGE	TABLET, FILM COATED	1	23
16837-855-09	PEPCID ACMaximum Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	23
16837-855-12	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-12	PEPCID ACMaximum Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	23
16837-855-13	PEPCID ACMaximum Strength	1 in 1 POUCH	TABLET, FILM COATED	1	23
16837-855-14	PEPCID ACMaximum Strength	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	23
16837-855-14	PEPCID ACMaximum Strength	5 in 1 CARTON	TABLET, FILM COATED	5	23
16837-855-15	PEPCID ACMaximum Strength	35 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	35	23
16837-855-15	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-16	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-16	PEPCID ACMaximum Strength	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	23
16837-855-17	PEPCID ACMaximum Strength	65 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	65	23
16837-855-17	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-18	PEPCID ACMaximum Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	23
16837-855-18	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-19	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-19	PEPCID ACMaximum Strength	8 in 1 BLISTER PACK	TABLET, FILM COATED	8	23
16837-855-20	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-20	PEPCID ACMaximum Strength	2 in 1 PACKAGE	TABLET, FILM COATED	2	23
16837-855-24	PEPCID ACMaximum Strength	1 in 1 POUCH	TABLET, FILM COATED	1	23
16837-855-24	PEPCID ACMaximum Strength	2500 in 1 CARTON	TABLET, FILM COATED	2500	23
16837-855-25	PEPCID ACMaximum Strength	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	23
16837-855-25	PEPCID ACMaximum Strength	5 in 1 CARTON	TABLET, FILM COATED	5	23
16837-855-40	PEPCID ACMaximum Strength	8 in 1 BLISTER PACK	TABLET, FILM COATED	8	23
16837-855-40	PEPCID ACMaximum Strength	5 in 1 CARTON	TABLET, FILM COATED	5	23
16837-855-49	PEPCID ACMaximum Strength	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	23
16837-855-49	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-50	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-50	PEPCID ACMaximum Strength	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	23
16837-855-51	PEPCID ACMaximum Strength	12 in 1 CARTON	TABLET, FILM COATED	12	23
16837-855-51	PEPCID ACMaximum Strength	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	23
16837-855-52	PEPCID ACMaximum Strength	50 in 1 TRAY	TABLET, FILM COATED	50	23
16837-855-52	PEPCID ACMaximum Strength	1 in 1 POUCH	TABLET, FILM COATED	1	23
16837-855-65	PEPCID ACMaximum Strength	65 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	65	23
16837-855-65	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-67	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-67	PEPCID ACMaximum Strength	65 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	65	23
16837-855-70	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-70	PEPCID ACMaximum Strength	70 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	70	23
16837-855-75	PEPCID ACMaximum Strength	75 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	75	23
16837-855-75	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-80	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-80	PEPCID ACMaximum Strength	80 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	80	23
16837-855-85	PEPCID ACMaximum Strength	85 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	85	23
16837-855-85	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-90	PEPCID ACMaximum Strength	125 in 1 PACKAGE, COMBINATION	TABLET, FILM COATED	125	23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16837-855	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [KENVUE BRANDS LLC]	23	Current NDC, Legacy NDC, 50 package rows	20241114_2854047f-c5c4-43c3-8ef2-5c0a84a307f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16837-855-14	EA - Each	16837-855	f235e0f8-899b-4d70-b432-965d7c89b25c	1	2020-05-08
16837-855-20	EA - Each	16837-855	4e0b3b00-4286-40fa-a8aa-8b200f0a17e7	1	2018-11-06
16837-855-25	EA - Each	16837-855	89ae8e30-8f54-4a60-b156-360669f64745	1	2018-03-08
16837-855-50	EA - Each	16837-855	16402839-23a8-4222-905a-c7d62af2b461	1	2018-03-08
16837-855-75	EA - Each	16837-855	662f0682-7aa8-4682-8bad-99d851f4bb76	1	2021-08-05
16837-855-90	EA - Each	16837-855	a5a3e34d-e891-46b1-895f-5175a172f94e	1	2021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Famotidine	ACTIVE INGREDIENT	5QZO15J2Z8	6
Famotidine	ACTIVE MOIETY	5QZO15J2Z8	6
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	6
hydroxypropyl cellulose (type L)	INACTIVE INGREDIENT	UKE75GEA7F	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	6
talc	INACTIVE INGREDIENT	7SEV7J4R1U	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	6

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

PEPCID AC Maximum Strength
Famotidine
CARNAUBA WAX
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16837-855	16837-855-05, 16837-855-25, 16837-855-49, 16837-855-50, 16837-855-52, 16837-855-65, 16837-855-67, 16837-855-70, 16837-855-75, 16837-855-90, 16837-855-80, 16837-855-85, 16837-855-09, 16837-855-12, 16837-855-13, 16837-855-14, 16837-855-15, 16837-855-17, 16837-855-18, 16837-855-40, 16837-855-51, 16837-855-16, 16837-855-20, 16837-855-19, 16837-855-24, 16837-855-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARNAUBA WAX	R12CBM0EIZ	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FAMOTIDINE	5QZO15J2Z8	ACTIB

Source Document#

Source XML · Source PDF

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 4 · 189 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL	1 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hydroxypropyl cellulose (type L)	HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	TABLET, FILM COATED / ORAL	32 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL	1 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hydroxypropyl cellulose (type L)	HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	TABLET, FILM COATED / ORAL	32 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hydroxypropyl cellulose (type L)	HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	TABLET, FILM COATED / ORAL	32 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL	1 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL	1 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hydroxypropyl cellulose (type L)	HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	TABLET, FILM COATED / ORAL	32 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hydroxypropyl cellulose (type L)	HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	TABLET, FILM COATED / ORAL	32 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hydroxypropyl cellulose (type L)	HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	TABLET, FILM COATED / ORAL	32 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL	1 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL	1 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hydroxypropyl cellulose (type L)	HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	TABLET, FILM COATED / ORAL	32 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL	1 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hydroxypropyl cellulose (type L)	HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	TABLET, FILM COATED / ORAL	32 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL	1 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
hydroxypropyl cellulose (type L)	HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	TABLET, FILM COATED / ORAL	32 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 27 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020325-001	PEPCID AC	FAMOTIDINE	10MG	TABLET / ORAL		RLD	1995-04-28
N020325-002	PEPCID AC	FAMOTIDINE	20MG	TABLET / ORAL		RLD, RS	2003-09-23

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 3 · 86 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	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`74a2ff9319b5…`

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 AC Maximum Strength	FAMOTIDINE	Kenvue Brands LLC	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	2024-11-11	Warnings	Exact identifier ndc (package): 16837-855-75 ndc (package): 16837-855-17 ndc (package): 16837-855-24 ndc (package): 16837-855-15 ndc (package): 16837-855-70 ndc (package): 16837-855-49 ndc (package): 16837-855-20 ndc (package): 16837-855-40 ndc (package): 16837-855-50 ndc (package): 16837-855-51 ndc (package): 16837-855-12 ndc (package): 16837-855-65 ndc (package): 16837-855-80 ndc (package): 16837-855-09 ndc (package): 16837-855-18 ndc (package): 16837-855-85 ndc (package): 16837-855-16 ndc (package): 16837-855-13 ndc (package): 16837-855-19 ndc (package): 16837-855-67 ndc (package): 16837-855-25 ndc (package): 16837-855-52 ndc (package): 16837-855-14 ndc (package): 16837-855-90 ndc (package): 16837-855-02 ndc (package): 16837-855-05 ndc (product): 16837-855 ndc11 (package): 16837085552 ndc11 (package): 16837085520 ndc11 (package): 16837085549 ndc11 (package): 16837085502 ndc11 (package): 16837085580 ndc11 (package): 16837085565 ndc11 (package): 16837085567 ndc11 (package): 16837085525 ndc11 (package): 16837085551 ndc11 (package): 16837085540 ndc11 (package): 16837085517 ndc11 (package): 16837085590 ndc11 (package): 16837085550 ndc11 (package): 16837085585 ndc11 (package): 16837085514 ndc11 (package): 16837085505 ndc11 (package): 16837085570 ndc11 (package): 16837085509 ndc11 (package): 16837085515 ndc11 (package): 16837085519 ndc11 (package): 16837085524 ndc11 (package): 16837085575 ndc11 (package): 16837085516 ndc11 (package): 16837085512 ndc11 (package): 16837085513 ndc11 (package): 16837085518 spl id: 21af0de6-18c5-b8e8-e063-6394a90af51f spl set id: 2854047f-c5c4-43c3-8ef2-5c0a84a307f2

Reported adverse events (FAERS/openFDA)#

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