Prilosec OTC®

Manufacturer: The Procter & Gamble Manufacturing Company | AstraZeneca AB (Sweden)
Effective date: 2026-10-05
Label type: HUMAN OTC DRUG LABEL
Version: 18
Source: daily-update
Hydrated at: 2026-10-07 01:03:18

Label at a glance#

ProductPrilosec OTC

Active ingredientOMEPRAZOLE MAGNESIUM

Label structure19 sections

Dosage and administration

for adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless di...

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) and protect from moisture

Contacts and useful links#

PhoneLabel contact1-800-289-9181

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

treats frequent heartburn (occurs 2 or moredays a week)
not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

WARNINGS SECTION

Allergy alert:
• Do not use if you are allergic to omeprazole.
• Omeprazole may cause severe skin reactions. Symptoms may include:
• skin reddening • blisters • rash
If an allergic reaction occurs, stop use and seek medical help right away.

OTC - DO NOT USE SECTION

Do not use if you have:

trouble or pain swallowing food, vomiting with blood, or bloody or black stools
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulderpain with shortness of breath; sweating; pain spreading to arms, neck, or shoulders; or lightheadedness
frequent chest pain

These may be signs of a serious condition. See your doctor.

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.
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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
• you need to take more than 1 course of treatment every 4 months
• you get diarrhea

• you develop a rash or joint pain

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

for adults 18 years of age and older
this product is to be used once a day (every 24 hours), every day for 14 days
it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment
- swallow 1 tablet with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 tablet a day
- do not use for more than 14 days unless directed by your doctor
- swallow whole. Do not chew, crush, or suck tablets.
Repeated 14-Day Courses (if needed)
- you may repeat a 14-day course every 4 months
- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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) and protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, flavor, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, saccharin sodium, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

Questions?

OTC - QUESTIONS SECTION

1-800-289-9181

SPL UNCLASSIFIED SECTION

Safety Feature - Do not use if tablet blister unit is open or torn.

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati, OH 45202

Product of Sweden

PRINCIPAL DISPLAY PANEL - 14 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See current Drug Facts NDC 37000-459-02

Treats FREQUENT Heartburn! 24 HR

Prilosec OTC ®

omeprazole delayed-release tablets

20 mg / acid reducer

SWALLOW - DO NOT CHEW

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

WILDBERRY Coated Tablet

459

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0037000808367	GTIN-13: 0037000808367 EAN-13: 0037000808367 GTIN-12: 037000808367 UPC-A: 037000808367 GTIN storage (14 digits): 00037000808367	459.jpg
Data code	Data Matrix	91443618		459.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37000-459-01	2021-02-12	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-01	2021-02-12	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-02	2021-02-12	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-02	2021-02-12	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-03	2021-02-12	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-03	2021-02-12	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-04	2021-02-12	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-04	2021-02-12	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-05	2021-02-12	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-05	2021-02-12	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-01	2021-01-29	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-01	2021-01-29	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-02	2021-01-29	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-02	2021-01-29	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-03	2021-01-29	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-03	2021-01-29	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-04	2021-01-29	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-04	2021-01-29	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-05	2021-01-29	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY
37000-459-05	2021-01-29	C162847	48780-1	ba0f9c33-20c3-a910-e053-dadaa90a0b85	Prilosec OTC® WILDBERRY

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37000-459-02	EA - Each	37000-459	bfe87c2f-a3bb-4f43-bbd8-f49e931e921c	1	2015-10-02
37000-459-03	EA - Each	37000-459	9ac76b4b-e558-4228-85eb-68b0c1fbd23b	1	2014-12-01
37000-459-04	EA - Each	37000-459	71d027f7-e084-49a3-9a60-23f8abd4d57a	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OMEPRAZOLE MAGNESIUM	ACTIVE INGREDIENT	426QFE7XLK	4
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	4
MICA	INACTIVE INGREDIENT	V8A1AW0880	4
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	4
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	4

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

Prilosec OTC
OMEPRAZOLE MAGNESIUM
OMEPRAZOLE
STARCH, RICE
POVIDONE K60
TRIETHYL CITRATE
FD&C BLUE NO. 2--ALUMINUM LAKE
FD&C RED NO. 40
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
MAGNESIUM STEARATE
MICA
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 6000
POLYSORBATE 80
SACCHARIN SODIUM
SODIUM STEARYL FUMARATE
SUCROSE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37000-459	37000-459-01, 37000-459-02, 37000-459-03, 37000-459-04, 37000-459-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OMEPRAZOLE MAGNESIUM	426QFE7XLK	ACTIM
STARCH, RICE	4DGK8B7I3S	IACT
POVIDONE K60	SZR7Z3Q2YH	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
FD&C BLUE NO. 2--ALUMINUM LAKE	4AQJ3LG584	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICA	V8A1AW0880	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
17	2025-10-01	full-release	2026-06-01 01:15:25

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 6 · 318 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, DELAYED RELEASE / ORAL		450 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii+route 102 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 132 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 132 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii+route 102 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii+route 132 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii+route 102 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 132 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii+route 102 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, DELAYED RELEASE / ORAL		450 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, DELAYED RELEASE / ORAL		120 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route 132 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, DELAYED RELEASE / ORAL		79 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii+route 132 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route 132 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, DELAYED RELEASE / ORAL		79 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 132 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii+route 102 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 132 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii+route 102 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route 132 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii+route 102 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii+route 132 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 132 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii+route 102 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 132 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route 132 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route 102 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii+route 132 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, DELAYED RELEASE / ORAL		120 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii+route 132 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 132 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
N021229-001	PRILOSEC OTC	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2003-06-20

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	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021229-001	6428810	2019-11-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021229-001	6403616	2019-11-15	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021229-001	6428810	2019-11-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021229-001	6403616	2019-11-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021229-001	6428810	2019-11-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021229-001	6403616	2019-11-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021229-001	6428810	2019-11-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021229-001	6403616	2019-11-15	`ea99ee380514…`

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
401e2c9f-fcc4-3d54-e063-6394a90a44e4			35a79458-79f6-44d6-b74c-b4f4aaf0dde0	2025-10-01	Warnings	Exact identifier spl set id: 35a79458-79f6-44d6-b74c-b4f4aaf0dde0

Reported adverse events (FAERS/openFDA)#

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