FDA.reportPublic FDA data

GUAIFENESIN DM

Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2024-11-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:36:45

Label at a glance#

ProductGUAIFENESIN DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN
Label structure14 sections

Indications and uses

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

Storage and handling

STORAGE: Keep tightly closed.  Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP].  Protect from light. 

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Non-Narcotic, Alcohol Free
Expectorant/Cough Suppressant

DESCRIPTION

OTC - ACTIVE INGREDIENT SECTION

Each 5 mL (1 teaspoonful) contains:
Guaifenesin100 mg
Dextromethorphan Hydrobromide10 mg

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. 

Sodium Content: 4 mg/5 mL

USES

INDICATIONS & USAGE SECTION

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

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 too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • you are hypersensitive to any of the ingredients.

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.

SPL UNCLASSIFIED SECTION

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Follow dosage below or use as directed by a physician.

  • do not take more than 6 doses in any 24-hour period.
age dose
adults and children
12 years and over 		10 mL (2 teaspoonfuls)
every 4 hours
children 6 years to
under 12 years 		5 mL (1 teaspoonful)
every 4 hours
children 2 years to
under 6 years 		2.5 mL (1/2 teaspoonful)
every 4 hours
children under 2 yearsask a doctor

HOW SUPPLIED SECTION

HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:

NDC 0121-0638-04:  4 fl oz (118 mL) bottle

NDC 0121-0638-08:  8 fl oz (237 mL) bottle

NDC 0121-0638-16:  16 fl oz (473 mL) bottle

NDC 0121­0638-05:  5 mL unit dose cup

NDC 0121-0638-00:  Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1276-10:  10 mL unit dose cup

NDC 0121-1276-00:  Case contains 100 unit dose cups of 10 mL (0121-1276-10) packaged in 10 trays of 10 unit dose cups each.

STORAGE AND HANDLING SECTION

STORAGE: Keep tightly closed.  Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP].  Protect from light. 

MANUFACTURED BY

SPL UNCLASSIFIED SECTION

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com 

R11/16

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL
NDC 0121-0638-05

GUAIFENESIN SYRUP
and DEXTROMETHORPHAN

100 mg/10 mg per 5 mL

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

5 mL unit dose cup label
5 mL unit dose cup label

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-0638-04
NSN 6505-01-318-1565

Quality®
Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the
active ingredients in
*Robitussin ®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES
CHEST CONGESTION

4 fl oz (118 mL)

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

118 mL bottle label
118 mL bottle label

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-0638-08

Quality®
Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the
active ingredients in
*Robitussin ®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES
CHEST CONGESTION

8 fl oz (237 mL)

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

237 mL bottle label
237 mL bottle label

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-0638-16

Quality®
Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the
active ingredients in
*Robitussin ®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES
CHEST CONGESTION

16 fl oz (473 mL)

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

473 mL bottle label
473 mL bottle label

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1276-10

GUAIFENESIN SYRUP

and DEXTROMETHORPHAN

200 mg/20 mg per 10 mL

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

10 unit dose cup label10 unit dose cup label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN8
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD8
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY8
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY8
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY8

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0638-00GUAIFENESIN DM10 in 1 CASESYRUP108
0121-0638-00GUAIFENESIN DM10 in 1 TRAYSYRUP108
0121-0638-04GUAIFENESIN DM118 mL in 1 BOTTLESYRUP1188
0121-0638-05GUAIFENESIN DM5 mL in 1 CUP, UNIT-DOSESYRUP58
0121-0638-08GUAIFENESIN DM237 mL in 1 BOTTLESYRUP2378
0121-0638-16GUAIFENESIN DM473 mL in 1 BOTTLESYRUP4738
0121-1276-00GUAIFENESIN DM10 in 1 TRAYSYRUP108
0121-1276-00GUAIFENESIN DM10 in 1 CASESYRUP108
0121-1276-10GUAIFENESIN DM10 mL in 1 CUP, UNIT-DOSESYRUP108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0638GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PAI HOLDINGS, LLC DBA PAI PHARMA]8Current NDC, Legacy NDC, 6 package rows20241113_ff970fff-d1a3-4322-83b4-34e361431a1c.zip
0121-1276GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PAI HOLDINGS, LLC DBA PAI PHARMA]8Current NDC, Legacy NDC, 3 package rows20241113_ff970fff-d1a3-4322-83b4-34e361431a1c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0638-00ML - Milliliter0121-0638af6ec9d0-3733-4833-bb65-947fe8affb5b12017-11-06
0121-0638-05ML - Milliliter0121-0638a524ff17-1835-4c50-926f-2f85abd8372212014-09-03
0121-0638-10ML - Milliliter0121-06381307fbf2-c43c-45b6-8e8b-d4c0aa0e2bcd12014-09-03
0121-1276-00ML - Milliliter0121-127685c39fa4-6419-4dec-9bae-36a45d499bda12017-12-14
0121-1276-10ML - Milliliter0121-1276e5a70701-5b1c-4cbb-b037-f9dcd4d92c6812017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHANACTIVE INGREDIENT7355X3ROTS1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GUAIFENESINACTIVE MOIETY495W7451VQ1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1

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
0121-06380121-0638-05, 0121-0638-00, 0121-0638-04, 0121-0638-08, 0121-0638-16
0121-12760121-1276-10, 0121-1276-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN7355X3ROTSACTIR
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCROSEC151H8M554IACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN7355X3ROTSACTIR
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCROSEC151H8M554IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT

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 2 · 63 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
9 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
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANPAI Holdings, LLC dba PAI Pharmaff970fff-d1a3-4322-83b4-34e361431a1c2024-11-11WarningsExact identifier
ndc (package): 0121-0638-08
ndc (package): 0121-1276-00
ndc (package): 0121-0638-04
ndc (package): 0121-1276-10
ndc (package): 0121-0638-16
ndc (package): 0121-0638-00
ndc (package): 0121-0638-05
ndc (product): 0121-0638
ndc (product): 0121-1276
ndc11 (package): 00121063816
ndc11 (package): 00121127610
ndc11 (package): 00121127600
ndc11 (package): 00121063800
ndc11 (package): 00121063805
ndc11 (package): 00121063804
ndc11 (package): 00121063808
spl id: c50b4c5c-6f55-4118-a282-e0b490704e49
spl set id: ff970fff-d1a3-4322-83b4-34e361431a1c

Reported adverse events (FAERS/openFDA)#

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