Delsym

Manufacturer
Rebel Distributors Corp
Effective date
2011-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:26:55

Label at a glance#

ProductDelsym
Active ingredientDEXTROMETHORPHAN
Label structure8 sections

Indications and uses

Use(s) 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

Directions • 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, ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan Polistirex

Purpose

OTC - PURPOSE SECTION

Use(s)

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

Uses

INDICATIONS & USAGE SECTION

Use(s)

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

Warnings

Do not use

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

• chronic cough that lasts as occurs with smoking, asthma or emphysema

• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

If pregnant or breast-feeding

Keep out of reach of children

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

Directions

• 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

• each 5 mL contains: sodium 7 mg

• store at 20°-25°C (68°-77°F)

• dosing cup provided

Drug Facts

Distributed by: Reckitt Benckiser Inc., Parsippany, NJ 07054-0224 ©RBI 2009

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

citric acid anhydrous, D&C Red #33, edetate disodium, ethylcellulose, FD&C Blue #1, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben,

purified water, sucrose, tragacanth, vegetable oil, xanthan gum

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delsym 30mg/ 5mlDelsym 30mg/ 5ml

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delsym 30mg/ 5mlDelsym 30mg/ 5ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373128Delsym 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN1
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN1
137312812 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]SBD1
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD1
1373128Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release SuspensionSY1
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY1
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-517-302019-09-24C16284748780-1934fe258-4899-48b1-e053-8cdaa90a720aDrug Facts
21695-518-302019-09-24C16284748780-1934fe258-4899-48b1-e053-8cdaa90a720aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-517-30Delsym90 mL in 1 BOTTLESYRUP901
21695-518-30Delsym90 mL in 1 BOTTLESYRUP901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-517DELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_4abb0813-e080-4bae-b829-e2c29d0a8d4f.zip
21695-518DELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_4abb0813-e080-4bae-b829-e2c29d0a8d4f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-171-63ML - Milliliter63824-1711bddda2c-79bb-42f5-b372-f91183329d6d12012-07-24
63824-171-65ML - Milliliter63824-171abd6b6f5-948c-4c45-a390-9bae52a45eda12012-07-24
63824-172-63ML - Milliliter63824-172d072cd6c-371b-475e-b764-697fe8c81a5e12012-07-24
63824-172-65ML - Milliliter63824-1727b8e5c0f-75f1-4eb6-8980-0a79e87827e412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHANACTIVE INGREDIENT7355X3ROTS1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
CORN OILINACTIVE INGREDIENT8470G57WFM1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4B1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5P1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SUCROSEINACTIVE INGREDIENTC151H8M5541
TRAGACANTHINACTIVE INGREDIENT2944357O2O1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-51721695-517-30
63824-171
21695-51821695-518-30
63824-172

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 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 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION, EXTENDED RELEASE / ORAL3000 mgExact identifier — unii+route+dosage form
TRAGACANTHTRAGACANTH2944357O2OSUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii+route+dosage form
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION, EXTENDED RELEASE / ORAL37 mgExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION, EXTENDED RELEASE / ORAL10 mgExact identifier — unii+route+dosage form
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii+route+dosage form
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii+route
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route
22 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii+route+dosage form
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route
22 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION, EXTENDED RELEASE / ORAL140.8 mgExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii+route
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route
22 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
22 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii+route
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
22 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018658-001DELSYMDEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0884e616aacf4f…
2026-08-18 06:07:402026-07N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-083f01610625f2…
2019-09-15 20:21 UTC2019-09N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DelsymDEXTROMETHORPHANReckitt Benckiser LLC234e6a2c-a280-4a39-8777-9316e9d681fb2026-05-27WarningsExact identifier
ndc (product): 63824-171
4abb0813-e080-4bae-b829-e2c29d0a8d4f4abb0813-e080-4bae-b829-e2c29d0a8d4f2011-01-12WarningsExact identifier
spl id: 4abb0813-e080-4bae-b829-e2c29d0a8d4f
spl set id: 4abb0813-e080-4bae-b829-e2c29d0a8d4f

Reported adverse events (FAERS/openFDA)#

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