FDA.reportPublic FDA data

NiteTime DayTime

Manufacturer
Kroger Company
Effective date
2014-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:37:03

Label at a glance#

ProductNiteTime DayTime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

temporarily relieves common cold/flu symptoms: • nasal congestion (Daytime only) • sore throat • headache • cough due to minor throat and bronchial irritation • fever • minor aches and pains • runny nose and sneezing (Nighttime only)

Dosage and administration

• take only as directed - see Liver warning • take Nighttime or Daytime • use dose cup • do not exceed 4 doses per 24 hrs Nighttime adults & children 12 yrs & over 30 ml (2 TBSP) every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use Daytime adults & children 12 yrs & over 30 ml (2 TBSP) every 4 hrs children 6 to under 12 yrs 15 ml (1 TBSP) every 4 hrs children 4 to under 6 yrs ask a d...

Storage and handling

(Nighttime) each 30 ml dose cup contains: sodium 38 mg (Daytime) each tablespoon contains: sodium 7 mg store at 20°-25°C (68°-77°)F

Label contents#

Full prescribing information#

Active ingredients for Nighttime (in each 30 ml dose cup)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Active ingredients for Daytime (in each 15 ml tablespoon)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose - Daytime

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion (Daytime only)
  • sore throat
  • headache
  • cough due to minor throat and bronchial irritation
  • fever
  • minor aches and pains
  • runny nose and sneezing (Nighttime only)

Warnings

WARNINGS SECTION

Liver warning: These products contain acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours (Nighttime) and 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen in 24 hours (Daytime). Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount (Daytime only)
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a dug contains acetaminophen, ask a doctor or pharmacist.
  • 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 these products.
  • to make a child sleepy (Nighttime only)
  • if you have ever had an allergic reaction to these products or any of their ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers (Nighttime only)
  • taking the blood thinning drug warfarin

When using these products

OTC - WHEN USING SECTION

  • do no use more than directed

In addition, when using Nighttime:

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless (Daytime only)
  • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) (Daytime only)
  • pain or cough gets worse or lasts more than 7 days (Nighttime only)
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling present
  • cough comes back or occurs with rash or headaches 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

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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

  • take only as directed - see Liver warning
  • take Nighttime or Daytime
  • use dose cup
  • do not exceed 4 doses per 24 hrs

Nighttime

adults & children 12 yrs & over

30 ml (2 TBSP) every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Daytime

adults & children 12 yrs & over

30 ml (2 TBSP) every 4 hrs

children 6 to under 12 yrs

15 ml (1 TBSP) every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use

  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

STORAGE AND HANDLING SECTION

(Nighttime) each 30 ml dose cup contains: sodium 38 mg

(Daytime) each tablespoon contains: sodium 7 mg

store at 20°-25°C (68°-77°)F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Nighttime alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Daytime butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-632-6900

Principal Display Panel for Nighttime

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION. IF MISSING OR BROKEN RETURN TO STORE.

COMPARE TO active ingredients of VICKS® NYQUIL®

See bottom panel

ALCOHOL 10%

Multi-Symptom Relief

Cold & Flu

NiteTime

Pain Reliever/Fever Reducer – Acetaminophen

Cough Suppressant – Dextromethorphan HBr

Antihistamine – Doxylamine Succinate

Save when you buy DayTime and NiteTime!

Aches/Fever

Cough/Sneezing

Runny Nose

Cherry Flavor

10 FL OZ (295 ml) NITETIME

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION. IF MISSING OR BROKEN RETURN TO STORE.

COMPARE TO active ingredients of VICKS® DAYQUIL®

See bottom panel

ALCOHOL & ANTIHISTAMINE FREE

Multi-Symptom Relief

Non-Drowsy

Cold & Flu

DayTime

Pain Reliever/Fever Reducer – Acetaminophen

Cough Suppressant – Dextromethorphan HBr

Nasal Decongestant – Phenylephrine HCl

Save when you buy DayTime and Nitetime!

Aches/Fever

Cough

Nasal Congestion

Original Flavor

10 FL OZ (295 ml) DAYTIME

Kroger NiteTime DayTime 1.jpg
Kroger NiteTime DayTime 1.jpg
Kroger NiteTime DayTime 2.jpg
Kroger NiteTime DayTime 2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-733-012020-11-19C16284748780-19d75b9cf-f233-f424-e053-dadaa90a57ceKroger Co. NiteTime DayTime Drug Facts
30142-733-012020-01-31C16284748780-19d75b9cf-f233-f424-e053-dadaa90a57ceKroger Co. NiteTime DayTime Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI21
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
DOXYLAMINEACTIVE MOIETY95QB77JKPL1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SW1
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-73330142-733-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ALCOHOL3K9958V90MIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM CITRATE1Q73Q2JULRIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCROSEC151H8M554IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

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 11 · 623 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AJELLY / NASAL32.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, DELAYED RELEASE / ORAL0.02 mgExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRACARDIAC25 mgExact identifier — unii candidate
61 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii candidate
28 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAMUSCULAR25 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, EXTENDED RELEASE / ORAL4.59 mgExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION/ DROPS / AURICULAR (OTIC)1 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAVENOUS1152 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USOLUTION / ORAL5 mgExact identifier — unii candidate
24 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2ULOTION / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM / BUCCAL9 mgExact identifier — unii candidate
61 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGUM, CHEWING / BUCCAL89 mgExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
24 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 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
9994ec0d-8f46-4f3d-abbb-ae60668aac550d505f7e-b1e6-422d-a047-7cfbb2b322f72020-10-01WarningsExact identifier
spl set id: 0d505f7e-b1e6-422d-a047-7cfbb2b322f7

Reported adverse events (FAERS/openFDA)#

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