Delsym ® Extended-Release Suspension

Manufacturer: Reckitt Benckiser LLC
Effective date: 2026-05-20
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:58:21

Label at a glance#

ProductDelsym (Dextromethorphan)

Active ingredientDEXTROMETHORPHAN

Label structure11 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

Dosage and administration

shake bottle well before use measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL ...

Storage and handling

each 5 mL contains: sodium 7 mg store at 20-25°C (68-77°F) dosing cup provided

Contacts and useful links#

PhoneLabel contact1-866-682-4639

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves

cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not useif 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

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, 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.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

shake bottle well before use
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor

adults and children 12 years of age and over	10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age	5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age	2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
children under 4 years of age	do not use

Other information

STORAGE AND HANDLING SECTION

each 5 mL contains: sodium 7 mg
store at 20-25°C (68-77°F)
dosing cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, D&C red no. 33, edetate disodium, ethylcellulose, FD&C blue no. 1, flavor, high fructose corn syrup, methylparaben, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-866-682-4639

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-173-65

Ages 4+

Children's
Delsym ^®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH

Day
or
Night

12
HOUR
COUGH RELIEF _™

Grape
Flavored Liquid

148 mL (5 fl oz)

For Children & Adults

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1373128	Delsym 30 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	5
1373045	dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	5
1373128	12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]	SBD	5
1373045	12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension	SCD	5
1373128	Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release Suspension	SY	5
1373045	dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension	SY	5
1373045	dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension	SY	5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63824-173-63	2022-06-21	C162847	48780-1	9d75b9d0-5a01-f424-e053-dadaa90a57ce	Delsym ® Extended-Release Suspension
63824-173-65	2022-06-21	C162847	48780-1	9d75b9d0-5a01-f424-e053-dadaa90a57ce	Delsym ® Extended-Release Suspension
63824-173-63	2022-01-28	C162847	48780-1	9d75b9d0-5a01-f424-e053-dadaa90a57ce	Delsym ® Extended-Release Suspension
63824-173-65	2022-01-28	C162847	48780-1	9d75b9d0-5a01-f424-e053-dadaa90a57ce	Delsym ® Extended-Release Suspension
63824-173-63	2020-07-28	C162847	48780-1	9d75b9d0-5a01-f424-e053-dadaa90a57ce	Delsym ® Extended-Release Suspension
63824-173-65	2020-07-28	C162847	48780-1	9d75b9d0-5a01-f424-e053-dadaa90a57ce	Delsym ® Extended-Release Suspension
63824-173-63	2020-01-31	C162847	48780-1	9d75b9d0-5a01-f424-e053-dadaa90a57ce	Delsym ® Extended-Release Suspension
63824-173-65	2020-01-31	C162847	48780-1	9d75b9d0-5a01-f424-e053-dadaa90a57ce	Delsym ® Extended-Release Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63824-173-63	Delsym (Dextromethorphan)	89 mL in 1 BOTTLE	SUSPENSION, EXTENDED RELEASE	89	5
63824-173-63	Delsym (Dextromethorphan)	1 in 1 CARTON	SUSPENSION, EXTENDED RELEASE	1	5
63824-173-65	Delsym (Dextromethorphan)	148 mL in 1 BOTTLE	SUSPENSION, EXTENDED RELEASE	148	5
63824-173-65	Delsym (Dextromethorphan)	1 in 1 CARTON	SUSPENSION, EXTENDED RELEASE	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-173-63	ML - Milliliter	63824-173	38c32416-7e7f-4110-8732-f36a5cc28e95	1	2015-10-02
63824-173-65	ML - Milliliter	63824-173	27022dd2-7b65-45d3-a131-97a2f71e866b	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN	ACTIVE INGREDIENT	7355X3ROTS	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POLISTIREX	INACTIVE INGREDIENT	5H9W9GTW27	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
TRAGACANTH	INACTIVE INGREDIENT	2944357O2O	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Delsym (Dextromethorphan)
Dextromethorphan
POLISTIREX
ANHYDROUS CITRIC ACID
D&C RED NO. 33
EDETATE DISODIUM
ETHYLCELLULOSE, UNSPECIFIED
FD&C BLUE NO. 1
HIGH FRUCTOSE CORN SYRUP
METHYLPARABEN
POLYETHYLENE GLYCOL 3350
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SUCROSE
TRAGACANTH
XANTHAN GUM
DEXTROMETHORPHAN HYDROBROMIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63824-173	63824-173-63, 63824-173-65

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
Name	UNII	Kind
POLISTIREX	5H9W9GTW27	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ETHYLCELLULOSE, UNSPECIFIED	7Z8S9VYZ4B	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SUCROSE	C151H8M554	IACT
TRAGACANTH	2944357O2O	IACT
XANTHAN GUM	TTV12P4NEE	IACT
DEXTROMETHORPHAN	7355X3ROTS	ACTIR

Source Document#

Source XML · Source PDF

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 · 105 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route 66 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route 66 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUSPENSION, EXTENDED RELEASE / ORAL		37 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii+route 66 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION, EXTENDED RELEASE / ORAL		3000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii+route 66 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii+route 66 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 66 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUSPENSION, EXTENDED RELEASE / ORAL		37 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii+route 66 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route 66 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SOLUTION / ORAL	0.04 mg/5ml		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION, EXTENDED RELEASE / ORAL		3000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018658-001	DELSYM	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	1982-10-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`f41ea6bd6efb…`

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
Delsym (Dextromethorphan)	DEXTROMETHORPHAN	Reckitt Benckiser LLC	bb0116d0-93e4-44e2-b0e4-c0b773eced6f	2026-05-20	Warnings	Exact identifier ndc (package): 63824-173-63 ndc (package): 63824-173-65 ndc (product): 63824-173 ndc11 (package): 63824017365 ndc11 (package): 63824017363 spl id: 5245a16e-bae3-b3d4-e063-6294a90ace45 spl set id: bb0116d0-93e4-44e2-b0e4-c0b773eced6f

Reported adverse events (FAERS/openFDA)#

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