FDA.reportPublic FDA data

AuroQuil Cold and Flu Nighttime Relief

Manufacturer
Aurohealth LLC
Effective date
2020-11-16
Label type
Human OTC Drug Label
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:05:25

Label at a glance#

ProductAuroQuil Cold and Flu Nighttime Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure18 sections

Indications and uses

temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing

Dosage and administration

take only as directed – see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours mL = milliliter; TBSP = tablespoon adults & children 12 years & over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use When using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Storage and handling

each 30 mL dose cup contains: potassium 5 mg, sodium 37 mg store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Active ingredients (in each 30 mL dose cup)                   Purpose

Acetaminophen, USP 650 mg                                       Pain reliever/fever reducer
Dextromethorphan HBr, USP 30 mg                                       Cough suppressant
Doxylamine succinate, USP 12.5 mg                                                Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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 drug 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 this product.
  • to make a child sleep

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with 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: Taking more than the recommended dose can cause serious health problems. 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

  • take only as directed – see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
  • mL = milliliter; TBSP = tablespoon
adults & children 12 years & over
30 mL (2 TBSP) every 6 hours
children 4 to under 12 years
ask a doctor
children under 4 years
do not use
  • When using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL dose cup contains: potassium 5 mg, sodium 37 mg
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavors, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or Comments?

OTC - QUESTIONS SECTION

1-855-274-4122

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
Compare to the active ingredients
in Vicks® NyQuil® Cold & Flu*

NDC 58602-137-18
AuroQuil
 COLD & FLU
 Nighttime Relief
Each dose (per 30 mL) (2 TBSP) of oral solution contains:
650 mg - Acetaminophen USP (Pain reliever/fever reducer)
12.5 mg - Doxylamine succinate USP (Antihistamine)
30 mg - Dextromethorphan HBr USP (Cough suppressant)

  • Aches, Fever & Sore Throat
  • Sneezing, Runny Nose
  • Cough

Alcohol 10%                         6 FL OZ (177 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
Compare to the active ingredients
in Vicks® NyQuil® Cold & Flu*

NDC 58602-137-20

AuroQuil
 COLD & FLU
 Nighttime Relief
Each dose (per 30 mL) (2 TBSP) of oral solution contains:
650 mg - Acetaminophen USP (Pain reliever/fever reducer)
12.5 mg - Doxylamine succinate USP (Antihistamine)
30 mg - Dextromethorphan HBr USP (Cough suppressant)

  • Aches, Fever & Sore Throat
  • Sneezing, Runny Nose
  • Cough

Alcohol 10%                     8 FL OZ (237 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (355 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
Compare to the active ingredients
in Vicks® NyQuil® Cold & Flu*

NDC 58602-137-16
AuroQuil
 COLD & FLU
 Nighttime Relief
Each dose (per 30 mL) (2 TBSP) of oral solution contains:
650 mg - Acetaminophen USP (Pain reliever/fever reducer)
12.5 mg - Doxylamine succinate USP (Antihistamine)
30 mg - Dextromethorphan HBr USP (Cough suppressant)


  • Aches, Fever & Sore Throat
  • Sneezing, Runny Nose
  • Cough

Alcohol 10%                                     12 FL OZ (355 mL)

 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (355 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (355 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL TWO 12 FL OZ (355 mL Bottles)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE
Twin Pack

AUROHEALTH
Compare to the active ingredients
in Vicks® NyQuil® Cold & Flu*


NDC 58602-137-35

AuroQuil
COLD & FLU
Nighttime Relief

Each dose (per 30 mL) (2 TBSP) of oral solution contains:
650 mg - Acetaminophen USP (Pain reliever/fever reducer)
12.5 mg - Doxylamine succinate USP (Antihistamine)
30 mg - Dextromethorphan HBr USP (Cough Suppressant)


  • Aches, Fever & Sore Throat
  • Sneezing, Runny Nose
  • Cough

 

Alcohol 10%                                       Total 24 FL OZ (710 mL)

                                                            Two 12 FL OZ (355 mL) Bottles

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL TWO 12 FL OZ (355 mL Bottles)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL TWO 12 FL OZ (355 mL Bottles)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI22
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS2
DOXYLAMINEACTIVE MOIETY95QB77JKPL2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G92
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
ANISEINACTIVE INGREDIENT21C2F5E8RE2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1S2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S2
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3A2
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33A2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-13758602-137-18, 58602-137-20, 58602-137-16, 58602-137-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ALCOHOL3K9958V90MIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ANISE21C2F5E8REIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

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 7 · 367 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ADROPS / OPHTHALMICNAExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii candidate
31 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE, LIQUID FILLED / ORAL360 mgExact identifier — unii candidate
61 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RECTAL904 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE / ORAL20 mgExact identifier — unii candidate
31 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SUSPENSION / ORAL45 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SSOLUTION / ORAL0.25 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii candidate
61 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CONCENTRATE / ORAL0.03 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33AGEL / DENTAL5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LIQUID / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / ORAL197 mgExact identifier — unii candidate
61 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION, EXTENDED RELEASE / ORAL3000 mgExact identifier — unii candidate
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / RECTAL0.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
31 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION, EXTENDED RELEASE / ORAL0.12 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SSOLUTION / TOPICALNAExact identifier — unii candidate
15 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL / TOPICAL0.08 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SOLUTION / ORAL40 mgExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 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
bb369577-748c-4bd9-99d5-02f30df1ee4a8144d201-93b1-4bd2-b150-361e610bd4d82020-11-16WarningsExact identifier
spl id: bb369577-748c-4bd9-99d5-02f30df1ee4a
spl set id: 8144d201-93b1-4bd2-b150-361e610bd4d8

Reported adverse events (FAERS/openFDA)#

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