Dextromethorphan HBr and Guaifenesin

Manufacturer: Akorn | Akorn Operating Company LLC
Effective date: 2022-03-08
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:48:39

Label at a glance#

ProductDextromethorphan HBr and Guaifenesin

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure8 sections

Indications and uses

• temporarily relieves cough • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Dosage and administration

• take every 4 hours • do not exceed 6 doses in 24 hours Age Dose Adults & children 12 years & over 10 mL (2 teaspoonfuls) Children 6 years to under 12 years 5 mL (1 teaspoonful) Children 2 years to under 6 years 2.5 mL (1/2 teaspoonful) Children under 2 years Ask a doctor How Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following ...

Contacts and useful links#

PhoneLabel contact1-800-262-9010

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Each 5 mL (1 teaspoonful) contains:

Dextromethorphan HBr ................................10 mg

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame potassium, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough
helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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 two 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

a cough that occur with too much phlegm (mucus)
a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

a cough lasts more than 7 days, comes back, or occurs with fever, 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

In case of overdose, get medical help or contact a Poison Control Center right away.

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).

Directions

DOSAGE & ADMINISTRATION SECTION

take every 4 hours
do not exceed 6 doses in 24 hours

Age	Dose
Adults & children 12 years & over	10 mL (2 teaspoonfuls)
Children 6 years to under 12 years	5 mL (1 teaspoonful)
Children 2 years to under 6 years	2.5 mL (1/2 teaspoonful)
Children under 2 years	Ask a doctor

How Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

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

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call 1-800-262-9010.

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev.062:01 4/13

MG #29851

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 50383-062-10

DEXTROMETHORPHAN HBr & GUAIFENESIN ORAL SOLUTION

20 mg/200 mg per 10 mL

Sugar Free/Alcohol Free

COUGH SUPPRESSANT/EXPECTORANT

SEE INSERT

FOR INSTITUTIONAL USE ONLY

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 062:01 4/13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	5
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	5
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	5
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	5
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-062-06	2024-01-30	C162847	48780-1	1030e365-1db9-111a-e063-dadaa90a10e2	Drug Facts
50383-062-07	2024-01-30	C162847	48780-1	1030e365-1db9-111a-e063-dadaa90a10e2	Drug Facts
50383-062-11	2024-01-30	C162847	48780-1	1030e365-1db9-111a-e063-dadaa90a10e2	Drug Facts
50383-062-12	2024-01-30	C162847	48780-1	1030e365-1db9-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50383-062-05	Dextromethorphan HBr and Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-062-05	Dextromethorphan HBr and Guaifenesin	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	5
50383-062-06	Dextromethorphan HBr and Guaifenesin	4 in 1 CASE	SOLUTION	4	5
50383-062-07	Dextromethorphan HBr and Guaifenesin	10 in 1 CASE	SOLUTION	10	5
50383-062-07	Dextromethorphan HBr and Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-062-10	Dextromethorphan HBr and Guaifenesin	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	5
50383-062-10	Dextromethorphan HBr and Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-062-11	Dextromethorphan HBr and Guaifenesin	4 in 1 CASE	SOLUTION	4	5
50383-062-12	Dextromethorphan HBr and Guaifenesin	10 in 1 TRAY	SOLUTION	10	5
50383-062-12	Dextromethorphan HBr and Guaifenesin	10 in 1 CASE	SOLUTION	10	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-062	DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [AKORN]	5	Legacy NDC, 10 package rows	20220309_ed74de02-852a-4dfe-8462-fa22044a2258.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-062-05	ML - Milliliter	50383-062	3b76b61d-6899-435b-8d7b-f22839e108c3	1	2013-03-03
50383-062-06	ML - Milliliter	50383-062	33711fd0-1dcd-49bd-96e0-872094c2444e	1	2013-04-01
50383-062-07	ML - Milliliter	50383-062	c141208d-32c2-42be-8255-dd4390799d58	1	2013-04-01
50383-062-10	ML - Milliliter	50383-062	60cbe226-4e0b-4d6e-886c-ca1d2e0e621b	1	2013-03-03
50383-062-11	ML - Milliliter	50383-062	374a31ec-bcfd-4172-9491-42fd98a7fbd1	1	2013-04-01
50383-062-12	ML - Milliliter	50383-062	a6540397-da10-4136-aaad-7a30c5d09a92	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	2
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Dextromethorphan HBr and Guaifenesin
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
ACESULFAME POTASSIUM
ASPARTAME
HYPROMELLOSE 2910 (4000 MPA.S)
MENTHOL, UNSPECIFIED FORM
METHYLPARABEN
POTASSIUM SORBATE
WATER
ANHYDROUS CITRIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50383-062	50383-062-05, 50383-062-06, 50383-062-07, 50383-062-10, 50383-062-11, 50383-062-12

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
Name	UNII	Kind
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ASPARTAME	Z0H242BBR1	IACT
HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
WATER	059QF0KO0R	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT

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 4 · 240 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, FILM COATED / ORAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	GEL / OPHTHALMIC		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CREAM / TOPICAL		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE, LIQUID FILLED / ORAL		360 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / RECTAL	6.67 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / ORAL		7 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	CAPSULE, EXTENDED RELEASE / ORAL		190 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL	ADJ PH		Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRAMUSCULAR		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	AEROSOL / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	POWDER, FOR SOLUTION / ORAL	117 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	SOLUTION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / RESPIRATORY (INHALATION)		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	MOUTHWASH / BUCCAL	0.15 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, FOR SUSPENSION / ORAL		15 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		35 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		81 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / SUBLINGUAL		36 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION/ DROPS / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	JELLY / TOPICAL		1368 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION/ DROPS / AURICULAR (OTIC)		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	LOZENGE / ORAL		136 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	GRANULE, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TROCHE / ORAL		26 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / SUBLINGUAL		13 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c9b98014-38e5-4347-b26d-43c4c3aa7da1			ed74de02-852a-4dfe-8462-fa22044a2258	2022-03-08	Warnings	Exact identifier spl id: c9b98014-38e5-4347-b26d-43c4c3aa7da1 spl set id: ed74de02-852a-4dfe-8462-fa22044a2258

Reported adverse events (FAERS/openFDA)#

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