VAZALORE (aspirin) Capsules

Manufacturer
PLx Pharma Inc
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:50:08

Label at a glance#

ProductVAZALORE
Active ingredientASPIRIN
Label structure19 sections

Indications and uses

For temporary relief of minor aches and pains associated with: headache Backache muscular aches a cold toothache minor pains of arthritis premenstrual and menstrual cramps temporarily redices fever n ask your doctor about other uses of aspirin capsules

Dosage and administration

Directions Drink a full glass of water with each dose Adults and children 12 years and over: Take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist Do not exceed 12 capsules in 24 hours Children under 12 years consult a doctor

Storage and handling

Other Information Save carton for full directions and warnings Store at 15-30°C (59-86°F) Avoid excessive heat above 40°C (104°F) Do not use if the blue band around the capsule is missing or broken

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief of minor aches and pains associated with:
  • headache
  • Backache
  • muscular aches
  • a cold
  • toothache
  • minor pains of arthritis
  • premenstrual and menstrual cramps
  • temporarily redices fever
  • n ask your doctor about other uses of aspirin capsules

Warnings

WARNINGS SECTION

Warnings

Reye’s Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

n hives n facial wseelling n shock n astham (wheezing)

This product contains soy

Stomach bleeding warning: This product contains an NSAID, which may cause 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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in Each capsules)

Aspirin (NSAID)* 325mg

*Non steroidal Anti inflammatory Drug

OTC - ASK DOCTOR SECTION

Ask a doctor before use if:

  • 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, or kidney disease
  • You are taking a diuretic
  • You have asthma

OTC - DO NOT USE SECTION

Do not use If you have ever had an allergic reaction to aspirin or any other pain reliever / fever reducer

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or a pharmacist before you use if you are

  • Taking a drug for diabetes, gout or arthritis

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • An allergic reaction occurs. Seek medical help right away
  • You experience amu of the following signs of stomach bleeding

- Feel faint - vomit blood - have bloody or black stool - have stomach pain that does not get better

  • Pain gets worse or lasts more than 10 days
  • Fever gets worse or lasts more than 3 days
  • Ringing in the ears or loss of hearing occurs
  • Redness and swelling is present in the painful area
  • Any new symptoms occur. These could be signs of serious conditions

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a healthcare professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery

OTC - PURPOSE SECTION

Purposes:

Aspirin (NSAID)* 325mg __ Pain reliever / fever reducer

*Non steroidal Anti inflammatory Drug

Questions or Comments

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-888-842-3569 9:00 AM – 7:00 PM ET, Monday – Friday

RETAIN CARTON FOR COMPLETE WARNINGS AND INFORMATION

Other Information

STORAGE AND HANDLING SECTION

Other Information

  • Save carton for full directions and warnings
  • Store at 15-30°C (59-86°F)
  • Avoid excessive heat above 40°C (104°F)
  • Do not use if the blue band around the capsule is missing or broken

INACTIVE INGREDIENT SECTION

Inactive ingredients

Anhydrous citric acid, carrageenan, colloidal silicon dioxide, FD&C blue #1, Hypromellose, lecithin, oleic acid, pharmaceutical ink, potassium chloride, soybean oil, titanium dioxide

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Drink a full glass of water with each dose
  • Adults and children 12 years and over:
    • Take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist
    • Do not exceed 12 capsules in 24 hours
  • Children under 12 years consult a doctor

30 Count Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 CT Bottle Carton30 CT Bottle Carton

30 Count Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 CT Bottle Label30 CT Bottle Label

4 Count Blister Card

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 ct blister card4 ct blister card

4 Count Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 Ct Blister Carton4 Ct Blister Carton

12 Count Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12 Ct Blister Carton12 Ct Blister Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252857aspirin 81 MG Oral CapsulePSN6
2563431Vazalore 81 MG Oral CapsulePSN6
2563431aspirin 81 MG Oral Capsule [Vazalore]SBD6
252857aspirin 81 MG Oral CapsuleSCD6
252857ASA 81 MG Oral CapsuleSY6
2563431ASA 81 MG Oral Capsule [Vazalore]SY6
2563431Vazalore 81 MG Oral CapsuleSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73089-081-12VAZALORE1 in 1 CARTONCAPSULE16
73089-081-12VAZALORE81 mg in 1 BLISTER PACKCAPSULE816
73089-081-14VAZALORE81 mg in 1 CARTONCAPSULE816
73089-081-21VAZALORE81 mg in 1 BOTTLE, PLASTICCAPSULE816
73089-081-21VAZALORE1 in 1 CARTONCAPSULE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73089-081VAZALORE (ASPIRIN) CAPSULE [PLX PHARMA INC]6Legacy NDC, 5 package rows20250101_c6d08008-2ac1-ab6e-e053-2a95a90a8aa2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73089-081-12EA - Each73089-081edebda8f-caf4-40f7-bde8-058050d940d112021-08-05
73089-081-21EA - Each73089-081bee005be-c369-4388-a359-ad8733422ffc12021-08-05

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73089-08173089-081-21, 73089-081-12, 73089-081-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203697-001VAZALOREASPIRIN325MGCAPSULE / ORALRLD, RS2013-01-14
N203697-002VAZALOREASPIRIN81MGCAPSULE / ORALRLD2021-02-26

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203697-001106464312032-09-29Drug product2023-04-05
N203697-001107864442032-09-29U-35592023-04-05
N203697-00192161502032-09-29Drug product2016-04-14
N203697-00192268922032-09-29U-17312016-04-14
N203697-00192268922032-09-29U-17322016-04-14
N203697-00192268922032-09-29U-17332016-04-14
N203697-002106464312032-09-29Drug product2023-04-05
N203697-002107864442032-09-29U-35592023-04-27

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 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-1484e616aacf4f…
2026-09-14 22:38:342026-08N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-2684e616aacf4f…
2026-08-18 06:07:402026-07N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-14caaa826d4ba7…
2026-08-18 06:07:402026-07N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N203697-002VAZALORE81MGCAPSULE / ORALRLD2021-02-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203697-001VAZALORE325MGCAPSULE / ORALRLD, RS2013-01-14bb7c543d1eb4…

Observed Orange Book patent history#

Patent history page 1 of 9 · 349 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N203697-001106464312032-09-29Drug product2023-04-0584e616aacf4f…
2026-09-14 22:38:342026-08N203697-001107864442032-09-29U-35592023-04-0584e616aacf4f…
2026-09-14 22:38:342026-08N203697-00192161502032-09-29Drug product2016-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N203697-00192268922032-09-29U-17332016-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N203697-00192268922032-09-29U-17312016-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N203697-00192268922032-09-29U-17322016-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N203697-002106464312032-09-29Drug product2023-04-0584e616aacf4f…
2026-09-14 22:38:342026-08N203697-002107864442032-09-29U-35592023-04-2784e616aacf4f…
2026-08-18 06:07:402026-07N203697-001106464312032-09-29Drug product2023-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N203697-001107864442032-09-29U-35592023-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N203697-00192161502032-09-29Drug product2016-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07N203697-00192268922032-09-29U-17332016-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07N203697-00192268922032-09-29U-17312016-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07N203697-00192268922032-09-29U-17322016-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07N203697-002106464312032-09-29Drug product2023-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N203697-002107864442032-09-29U-35592023-04-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N203697-001106464312032-09-29Drug product2023-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203697-001107864442032-09-29U-35592023-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203697-00192161502032-09-29Drug product2016-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203697-00192268922032-09-29U-17332016-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203697-00192268922032-09-29U-17312016-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203697-00192268922032-09-29U-17322016-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203697-002106464312032-09-29Drug product2023-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203697-002107864442032-09-29U-35592023-04-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203697-001106464312032-09-29Drug product2023-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203697-001107864442032-09-29U-35592023-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203697-00192161502032-09-29Drug product2016-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203697-00192268922032-09-29U-17332016-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203697-00192268922032-09-29U-17312016-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203697-00192268922032-09-29U-17322016-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203697-002106464312032-09-29Drug product2023-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203697-002107864442032-09-29U-35592023-04-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N203697-001106464312032-09-29Drug product2023-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203697-001107864442032-09-29U-35592023-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203697-00192161502032-09-29Drug product2016-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203697-00192268922032-09-29U-17332016-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203697-00192268922032-09-29U-17312016-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203697-00192268922032-09-29U-17322016-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203697-002106464312032-09-29Drug product2023-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203697-002107864442032-09-29U-35592023-04-276a471c1ec25d…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2a8902c7-0a87-5d9e-e063-6394a90a4198c6d08008-2ac1-ab6e-e053-2a95a90a8aa22024-12-30WarningsExact identifier
spl id: 2a8902c7-0a87-5d9e-e063-6394a90a4198
spl set id: c6d08008-2ac1-ab6e-e053-2a95a90a8aa2

Reported adverse events (FAERS/openFDA)#

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