naproxen sodium - Bionpharma Inc. | Patheon Softgels Inc.

Manufacturer: Bionpharma Inc. | Patheon Softgels Inc.
Effective date: 2026-10-05
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: daily-update
Hydrated at: 2026-10-07 01:02:43

Label at a glance#

Productnaproxen sodium

Active ingredientNAPROXEN SODIUM

Label structure11 sections

Indications and uses

temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever

Dosage and administration

do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose if taken with food, this product may take longer to work adults and children 12 years and older: take 1 capsule every 8 hours to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8-hour to 12-hour period do not exceed 3 caps...

Storage and handling

each capsule contains: sodium 20 mg store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) protect from light read all directions and warnings before use.

Contacts and useful links#

PhoneLabel contact1-888-235-2466

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:
- backache
- muscular aches
- minor pain of arthritis
- menstrual cramps
- headache
- toothache
- the common cold
temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert:Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

SPL UNCLASSIFIED SECTION

Heart attack and stroke warning:NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

the stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
you are taking a diuretic
you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

under a doctor's care for any serious condition
taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
taking any other drug

When using this product

OTC - WHEN USING SECTION

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience any of the following signs of stomach bleeding:
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
you have symptoms of heart problems or stroke:
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
the smallest effective dose should be used
drink a full glass of water with each dose
if taken with food, this product may take longer to work

adults and children 12 years and older:	take 1 capsule every 8 hours to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8-hour to 12-hour period do not exceed 3 capsules in a 24-hour period
children under 12 years:	ask a doctor

Other information

STORAGE AND HANDLING SECTION

each capsule contains:sodium 20 mg
store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
protect from light
read all directions and warnings before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-888-235-2466(Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

Do not use if printed safety seal under cap is torn or missing.

***This product is not manufactured or distributed by the owners of ALEVE ^®Liquid Gels..

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

L0001254

R0326

Lot/EXP

PRINCIPAL DISPLAY PANEL - 180's Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*** compare tothe active ingredient in ALEVE® Liquid Gels

a+health

naproxen sodium capsules, 220 mg

(NSAID)

pain reliever/fever reducer

back & muscle pain relief

strength to last 12 hours

180 capsules**

**liquid-filled capsule

label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

naproxen sodium
NAPROXEN
MANNITOL
POLYETHYLENE GLYCOL, UNSPECIFIED
FD&C BLUE NO. 1
GELATIN
GLYCERIN
LACTIC ACID
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69452-284	69452-284-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
MANNITOL	3OWL53L36A	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
LACTIC ACID	33X04XA5AT	IACT
POVIDONE	FZ989GH94E	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
4	2026-04-20	full-release	2026-06-01 01:54:29

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
N021920-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL		RLD, RS	2006-02-17

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23
N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23
N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24
N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24
N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24
N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24
N021920-001	9693978	2026-03-03		Drug product	2017-11-13
N021920-001	9693979	2026-03-03		Drug product	2017-11-13

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	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 329 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`6a471c1ec25d…`

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
4fe826c9-b874-7e70-e063-6294a90a641b			ba4f927a-4bbe-0d87-e053-2995a90a8c20	2026-04-20	Warnings	Exact identifier spl set id: ba4f927a-4bbe-0d87-e053-2995a90a8c20

Reported adverse events (FAERS/openFDA)#

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