FDA.reportPublic FDA data

Wal-Mart Flu & Severe Cold & Cough Drug Facts

Manufacturer
Wal-Mart Stores Inc
Effective date
2026-09-17
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-09-22 03:02:32

Label at a glance#

ProductEquate Flu and Severe Cold and Cough
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and administration

do not use more than directed (see overdose warning) take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add co...

Storage and handling

each packet contains: potassium 10 mg and sodium 25 mg phenylketonurics: contains phenylalanine 13 mg per packet store at 20-25 ° C (68-77 ° F). Protect product from heat and moisture.

Label contents#

Full prescribing information#

Active ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • runny nose
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • in a child under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on skin
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed (see overdose warning)
  • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.

Age

Dose

adults and children 12 years of age and over

one packet

children under 12 years of age

do not use

  • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
  • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

Other information

STORAGE AND HANDLING SECTION

  • each packet contains:potassium 10 mg and sodium 25 mg
  • phenylketonurics:contains phenylalanine 13 mg per packet
  • store at 20-25 °C (68-77 °F). Protect product from heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

equate™

Nighttime

Flu & Severe Cold & Cough

Acetaminophen – Pain Reliever/Fever Reducer

Diphenhydramine HCl – Antihistamine/Cough Suppressant

Phenylephrine HCl – Nasal Decongestant

For relief of:

• Nasal congestion

• Cough

• Runny nose

• Sneezing

• Body ache

• Sore throat pain

• Headache/fever

Honey Lemon Infused with White Tea Flavors

6 PACKETS

equate-flu-&-severe-cold-&-cough-carton-image.jpg
equate-flu-&-severe-cold-&-cough-carton-image.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-964-912024-01-30C16284748780-11030e365-2616-111a-e063-dadaa90a10e2Wal-Mart Flu & Severe Cold & Cough Drug Facts
49035-964-912024-01-30C16284748780-11030e365-2616-111a-e063-dadaa90a10e2Wal-Mart Flu & Severe Cold & Cough Drug Facts
49035-964-912024-01-30C16284748780-11030e365-2616-111a-e063-dadaa90a10e2Wal-Mart Flu & Severe Cold & Cough Drug Facts
49035-964-912024-01-30C16284748780-11030e365-2616-111a-e063-dadaa90a10e2Wal-Mart Flu & Severe Cold & Cough Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-964-91EA - Each49035-9642f6d0d35-cd4c-443e-8111-3e142f2732bb12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D4
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD404
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ4
ACETAMINOPHENACTIVE MOIETY362O9ITL9D4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G94
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR14
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU44
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR4
SUCROSEINACTIVE INGREDIENTC151H8M5544
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z284

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-96449035-964-91

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASPARTAMEZ0H242BBR1IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
MALTODEXTRIN7CVR7L4A2DIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCROSEC151H8M554IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112026-03-29full-release2026-06-01 01:56:58
102025-11-12monthly-update2026-06-03 17:39:50
92024-07-15full-release2026-06-01 00:15:28

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 2 · 62 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET / ORAL330 mgExact identifier — unii+route
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, COATED / ORAL40 mgExact identifier — unii+route
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28CAPSULE, EXTENDED RELEASE / ORAL32.73 mgExact identifier — unii+route
16 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET / ORAL330 mgExact identifier — unii+route
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28CAPSULE, EXTENDED RELEASE / ORAL32.73 mgExact identifier — unii+route
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii+route
30 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii+route
30 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1POWDER, FOR SOLUTION / ORAL233 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, FILM COATED / ORAL21.8 mgExact identifier — unii+route
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route
30 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1POWDER, FOR SOLUTION / ORAL233 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, CHEWABLE / ORAL130 mgExact identifier — unii+route
16 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, COATED / ORAL40 mgExact identifier — unii+route
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28CAPSULE / ORAL176 mgExact identifier — unii+route
16 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, EXTENDED RELEASE / ORAL750 mgExact identifier — unii+route
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, DELAYED RELEASE / ORAL333.3 mgExact identifier — unii+route
16 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, DELAYED RELEASE / ORAL333.3 mgExact identifier — unii+route
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route
30 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii+route
30 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28CAPSULE / ORAL176 mgExact identifier — unii+route
16 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii+route
30 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, CHEWABLE / ORAL130 mgExact identifier — unii+route
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, FILM COATED / ORAL21.8 mgExact identifier — unii+route
16 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii+route
30 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, EXTENDED RELEASE / ORAL750 mgExact identifier — unii+route
16 equally ranked IID candidates

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
01e97e0a-ab3d-4a16-8a59-1667f4c3dd9290cc8dca-b448-402c-bb48-407039a626162026-03-29WarningsExact identifier
spl set id: 90cc8dca-b448-402c-bb48-407039a62616

Reported adverse events (FAERS/openFDA)#

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