FDA.reportPublic FDA data

Biodesp

Manufacturer
Advanced Generic Corporation
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:47:31

Label at a glance#

ProductBiodesp DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: (in each 5 mL tsp.)              Purpose

Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

Guaifenesin 100 mg .............................................. Expectorant

Phenylephrine HCl 5 mg.................................. Decongestant

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves these symptoms due to the common cold. hay fever (allergic rhinitis), or other upper respiratory allergies;
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bonchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

WARNINGS SECTION

Warnings

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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.

When using this product do not exceed recommended dosage

Ask a doctore before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • cough lasts for more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts. These could be signs of a serious condition

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 health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions Do not exceed 4 doses in 24 hours.

 adults and children 12 years of age and overtake 2 teaspoonfuls (10 mL) every 6 hours 
children 6 to under 12 years of age take 1 teaspoonful (5 mL) every 6 hours 
children 2 to under 6 years of age take 1/2 teaspoonful (2.5 mL) every 6 hours 
children under 2 years of age ask a doctor 

OTC - QUESTIONS SECTION

Questions or comments?1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33147.
www.advancedgeneric.com

INACTIVE INGREDIENT SECTION

Inactive ingredientsartificial flavor, citric acid, methylparaben, propylene glycol,
propylparaben, purified water, sodium citrate and sucralose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BiodespDMLabelBiodespDMLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1358620dextromethorphan HBr 15 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN6
1358620dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD6
1358620dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-221-162020-12-23C16284748780-19d75b9d0-7da7-f424-e053-dadaa90a57ceAGC-BiodespDM 221
45737-221-162020-01-31C16284748780-19d75b9d0-7da7-f424-e053-dadaa90a57ceAGC-BiodespDM 221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-221-16BiodespDM473 mL in 1 BOTTLELIQUID4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-221BIODESP DM (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]6Legacy NDC, 1 package rows20241222_6b303f1a-0a8b-43a9-bb31-d5a0d46becc7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-221-16ML - Milliliter45737-221fd396242-5971-4b45-8b70-9e58f24a6f0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH2
GuaifenesinACTIVE INGREDIENT495W7451VQ2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ2
DextromethorphanACTIVE MOIETY7355X3ROTS2
GuaifenesinACTIVE MOIETY495W7451VQ2
PhenylephrineACTIVE MOIETY1WS297W6MV2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V32
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH2
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULR2
SorbitolINACTIVE INGREDIENT506T60A25R2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45737-22145737-221-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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 · 381 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PropylparabenPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
44 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / RECTAL271 mgExact identifier — unii candidate
68 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERINEURAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 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
29bc2f0e-d2f7-7185-e063-6394a90ad8166b303f1a-0a8b-43a9-bb31-d5a0d46becc72024-12-20WarningsExact identifier
spl id: 29bc2f0e-d2f7-7185-e063-6394a90ad816
spl set id: 6b303f1a-0a8b-43a9-bb31-d5a0d46becc7

Reported adverse events (FAERS/openFDA)#

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