Coricidin HBP

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:20:28

Label at a glance#

ProductCoricidin HBP Day and Night
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE
Label structure16 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

do not exceed recommended dose do not take the Day and Night products at the same time; wait 4 hours after the last Night dose before starting Day product adults and children 12 years and over: 1 or 2 softgels every 4 hours, not more than 6 softgels in 12 hours children under 12 years of age: ask a doctor

Storage and handling

store between 20° to 25°C (68° to 77°F) protect from freezing protect from excessive moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Coricidin HBP Day

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each softgel)Purpose
Dextromethorphan hydrobromide 10 mgCough Suppressant
Guaifenesin 200 mgExpectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use 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

  • cough that occurs with excessive phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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. Abuse of this product can lead to serious injury.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dose
  • do not take the Day and Night products at the same time; wait 4 hours after the last Night dose before starting Day product
  • adults and children 12 years and over: 1 or 2 softgels every 4 hours, not more than 6 softgels in 12 hours
  • children under 12 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing
  • protect from excessive moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, pharmaceutical ink, polyethylene glycol 400, povidone, propylene glycol, sorbitol

SPL UNCLASSIFIED SECTION

Coricidin HBP Night

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Dextromethorphan hydrobromide 15 mgCough Suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves
    • minor aches and pains
    • headache
    • cough
    • runny nose
    • sneezing
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver Warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen.

Sever liver damage may occur if you take

  • more than 4 tablets in 12 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or non prescription). 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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with excessive phlegm (mucus)
  • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

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 a rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Abuse of this product can lead to serious injury.

Overdose Warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed (see overdose warning)
  • do not take the Day and Night products at the same time; wait 4 hours after the last Day dose before starting Night product
  • adults and children 12 years and over: 2 tablets at bedtime and every 6 hours if needed, while symptoms persist, not more than 4 tablets in a 12 hour period
  • children under 12 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, FD&C red No. 40 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-317-2165 (MoN-Fri 9AM-5PM EST)

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUAL FORMULA PACK

Coricidin ®

HBP

Decongestant-free COLD RELIEF for people

with HIGH BLOOD PRESSURE

DAY

MULTI-SYMPTOM COLD

Guaifenesin - Expectorant

Dextromethorphan HBr - Cough Suppressant

Day Relieves:

  • Chest Congestion
  • Cough

16 DAY SOFTGELS

NIGHT

Chlorpheniramine Maleate - Antihistamine,

Dextromethorphan HBr - Cough Suppressant,

Acetaminophen - Pain Reliever/Fever Reducer

See New Warnings Information

Night Relieves:

  • Runny Nose & Sneezing
  • Cough • Body Aches
  • Fever

8 NIGHT TABLETS

dndn

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1250983{1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) / 1 (dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral Capsule) } PackGPCK6
12509831 daytime (dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral Capsule) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet) PackPSN6
1098496acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral TabletPSN6
1111663dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSN6
1098496acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral TabletSCD6
1111663dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCD6
12509831 daytime (dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral Capsule) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet) PackSY6
1098496APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeITF0380960238096-02_us_coricidin_hbp_day_night_24ct.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4111-1Coricidin HBPDay and Night4 in 1 BLISTER PACKTABLET8500 mg6
11523-4111-1Coricidin HBPDay and Night2 in 1 CARTONTABLET2 mg6
11523-4221-1Coricidin HBPDay and Night8 in 1 BLISTER PACKCAPSULE, GELATIN COATED16200 mg6
11523-4221-1Coricidin HBPDay and Night2 in 1 CARTONCAPSULE, GELATIN COATED200 mg6
11523-4765-1Coricidin HBPDay and Night1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4765-1EA - Each11523-4765f9dd2fe9-dcd8-42d5-812b-e3a0d9fd860012017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
Chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9Z1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH1
GuaifenesinACTIVE INGREDIENT495W7451VQ1
AcetaminophenACTIVE MOIETY362O9ITL9D1
ChlorpheniramineACTIVE MOIETY3U6IO1965U1
DextromethorphanACTIVE MOIETY7355X3ROTS1
GuaifenesinACTIVE MOIETY495W7451VQ1
aluminum oxideINACTIVE INGREDIENTLMI26O69331
carnauba waxINACTIVE INGREDIENTR12CBM0EIZ1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOA1
gelatinINACTIVE INGREDIENT2G86QN327L1
hypromellosesINACTIVE INGREDIENT3NXW29V3WO1
lactoseINACTIVE INGREDIENTJ2B2A4N98G1
magnesium stearateINACTIVE INGREDIENT70097M6I301
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQ1
povidoneINACTIVE INGREDIENTFZ989GH94E1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
sorbitolINACTIVE INGREDIENT506T60A25R1
stearic acidINACTIVE INGREDIENT4ELV7Z65AP1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-476511523-4765-1
11523-422111523-4221-1
11523-411111523-4111-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

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 9 · 509 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ESUSPENSION/ DROPS / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
27 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZCAPSULE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii candidate
11 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
hypromellosesHYPROMELLOSE3NXW29V3WOINSERT / VAGINAL54.21 mgExact identifier — unii candidate
27 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ESUSPENSION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR133 mgExact identifier — unii candidate
36 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOATABLET / BUCCAL0.01 mgExact identifier — unii candidate
28 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
30 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQSPRAY, METERED / NASAL320 mgExact identifier — unii candidate
36 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GSOLUTION / RECTAL8 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
36 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOSYRUP / ORAL250 mgExact identifier — unii candidate
27 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii candidate
28 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
45370b45-6102-a96f-e063-6294a90a1721e33f2319-2181-46db-a094-3e874b324c0a2025-12-05WarningsExact identifier
spl id: 45370b45-6102-a96f-e063-6294a90a1721
spl set id: e33f2319-2181-46db-a094-3e874b324c0a

Reported adverse events (FAERS/openFDA)#

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