FDA.reportPublic FDA data

Delsym

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2024-04-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:11:13

Label at a glance#

ProductDelsym
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 mL = milliliter 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...

Storage and handling

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

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 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

  • chronic cough that lasts 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 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.

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
  • mL = milliliter
adults and children 12 years of age and over10 mL every 12 hours,
not to exceed 20 mL in 24 hours
children 6 to under 12 years of age5 mL every 12 hours,
not to exceed 10 mL in 24 hours
children 4 to under 6 years of age2.5 mL every 12 hours,
not to exceed 5 mL in 24 hours
children under 4 years of agedo 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:


ATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE

MIAMI, FL 33179

NDC 17856-0172-01Delsym® Dextromethorphan PolistirexExtended-Release Suspension (Cough Suppressant) COUGH 12HOURCOUGH RELIEF® GrapeFlavored Liquid 10mL CUP 72 PER CASE Day or NightSULFITE FREEALCOHOL FREE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373128Delsym 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN5
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN5
137312812 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]SBD5
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD5
1373128Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release SuspensionSY5
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY5
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY5

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
17856-0172-32024-04-19C16284748780-19d75b9cf-e8ac-f424-e053-dadaa90a57ceDelsym 12 Hour Cough Relief Grape
17856-0172-42024-04-19C16284748780-19d75b9cf-e8ac-f424-e053-dadaa90a57ceDelsym 12 Hour Cough Relief Grape
17856-0172-32024-01-30C16284748780-19d75b9cf-e8ac-f424-e053-dadaa90a57ceDelsym 12 Hour Cough Relief Grape
17856-0172-42024-01-30C16284748780-19d75b9cf-e8ac-f424-e053-dadaa90a57ceDelsym 12 Hour Cough Relief Grape
17856-0172-12020-08-21C16284748780-19d75b9cf-e8ac-f424-e053-dadaa90a57ceDelsym 12 Hour Cough Relief Grape
17856-0172-12020-01-31C16284748780-19d75b9cf-e8ac-f424-e053-dadaa90a57ceDelsym 12 Hour Cough Relief Grape

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0172-1Delsym10 mL in 1 CUP, UNIT-DOSESUSPENSION, EXTENDED RELEASE105
17856-0172-1Delsym72 in 1 BOX, UNIT-DOSESUSPENSION, EXTENDED RELEASE725
17856-0172-2Delsym72 in 1 BOX, UNIT-DOSESUSPENSION, EXTENDED RELEASE725
17856-0172-2Delsym5 mL in 1 CUP, UNIT-DOSESUSPENSION, EXTENDED RELEASE55
17856-0172-3Delsym1 in 1 CUP, UNIT-DOSESUSPENSION, EXTENDED RELEASE15
17856-0172-4Delsym1 in 1 CUP, UNIT-DOSESUSPENSION, EXTENDED RELEASE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0172DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORP.]5Legacy NDC, 6 package rows20240420_00f8f5b4-f5a8-4dcf-8133-15964ad4801e.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

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
17856-017217856-0172-1, 17856-0172-4, 17856-0172-2, 17856-0172-3
63824-171

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
NameUNIIKind
Dextromethorphan7355X3ROTSACTIR
Polistirex5H9W9GTW27IACT
anhydrous citric acidXF417D3PSLIACT
D&C Red NO. 339DBA0SBB0LIACT
edetate disodium7FLD91C86KIACT
ethylcellulose, unspecified7Z8S9VYZ4BIACT
FD&C Blue NO. 1H3R47K3TBDIACT
high fructose corn syrupXY6UN3QB6SIACT
methylparabenA2I8C7HI9TIACT
polyethylene glycol 3350G2M7P15E5PIACT
polysorbate 806OZP39ZG8HIACT
propylene glycol6DC9Q167V3IACT
propylparabenZ8IX2SC1OHIACT
water059QF0KO0RIACT
sucroseC151H8M554IACT
tragacanth2944357O2OIACT
xanthan gumTTV12P4NEEIACT

Source Document#

Source XML

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
cc5c2a0f-bedb-4702-829f-0bb7b3ea1abf00f8f5b4-f5a8-4dcf-8133-15964ad4801e2024-04-19WarningsExact identifier
spl id: cc5c2a0f-bedb-4702-829f-0bb7b3ea1abf
spl set id: 00f8f5b4-f5a8-4dcf-8133-15964ad4801e

Reported adverse events (FAERS/openFDA)#

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