FDA.reportPublic FDA data

cough dm

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-05-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:00:52

Label at a glance#

Productcough dm
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 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 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...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

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

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 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.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

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)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • 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,

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 1-800-222-1222.

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 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 to exceed 5 mL in 24 hours

children under 4 years of age

do not use

Other information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cough DM

Dextromethorphan Polistirex Extended-Release Oral Suspension

Cough Suppressant

12 HOUR COUGH RELIEF

Dosing Cup Included

Orange-Flavored Liquid

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

COMPARE TO the Active Ingredient of DELSYM®

Alcohol-free

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN6
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD6
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY6
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY6

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
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-6312-12024-11-18C16284748780-19d75b9d0-78d0-f424-e053-dadaa90a57ceDEXTROMETHORPHAN Major Pharmaceuticals Cough DM Drug Facts
17856-6312-22024-11-18C16284748780-19d75b9d0-78d0-f424-e053-dadaa90a57ceDEXTROMETHORPHAN Major Pharmaceuticals Cough DM Drug Facts
17856-6312-12023-01-30C16284748780-19d75b9d0-78d0-f424-e053-dadaa90a57ceDEXTROMETHORPHAN Major Pharmaceuticals Cough DM Drug Facts
17856-6312-22023-01-30C16284748780-19d75b9d0-78d0-f424-e053-dadaa90a57ceDEXTROMETHORPHAN Major Pharmaceuticals Cough DM Drug Facts
17856-6312-12021-01-29C16284748780-19d75b9d0-78d0-f424-e053-dadaa90a57ceDEXTROMETHORPHAN Major Pharmaceuticals Cough DM Drug Facts
17856-6312-12020-01-31C16284748780-19d75b9d0-78d0-f424-e053-dadaa90a57ceDEXTROMETHORPHAN Major Pharmaceuticals Cough DM Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-6312-1cough dm5 mL in 1 CUPSUSPENSION56
17856-6312-2cough dm10 mL in 1 CUPSUSPENSION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-6312COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [ATLANTIC BIOLOGICALS CORP.]6Current NDC, Legacy NDC, 2 package rows20250514_73aede9d-37dd-4aa5-a906-0e0c94cecff1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-6312-1ML - Milliliter17856-631210a1d941-ccf0-4a92-906a-5dc55e8548ca12025-06-13
17856-6312-2ML - Milliliter17856-631293cb3f20-cde6-475f-8fd8-8b6f69460e8d12025-06-13
0904-6312-56ML - Milliliter0904-63127391a909-4f84-4033-ac72-d4dcf3bef15412013-02-13

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-631217856-6312-1, 17856-6312-2
0904-6312

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLISTIREX5H9W9GTW27IACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SODIUM POLYSTYRENE SULFONATE1699G8679ZIACT
SUCROSEC151H8M554IACT
TARTARIC ACIDW4888I119HIACT
TRAGACANTH2944357O2OIACT
TRIACETINXHX3C3X673IACT
XANTHAN GUMTTV12P4NEEIACT
D&C RED NO. 302S42T2808BIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
POLYVINYL ACETATE32K497ZK2UIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
A091135-001DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25

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 22:38:342026-08A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2584e616aacf4f…
2026-08-18 06:07:402026-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253f01610625f2…
2019-09-15 20:21 UTC2019-09A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25f41ea6bd6efb…

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
cough dmDEXTROMETHORPHAN POLISTIREXMajor Pharmaceuticalscdb5616e-0f04-4b9e-a82b-994e9ba3b5152026-04-13WarningsExact identifier
ndc (product): 0904-6312
cough dmDEXTROMETHORPHAN POLISTIREXATLANTIC BIOLOGICALS CORP.73aede9d-37dd-4aa5-a906-0e0c94cecff12025-05-12WarningsExact identifier
ndc (package): 17856-6312-2
ndc (package): 17856-6312-1
ndc (product): 17856-6312
ndc11 (package): 17856631201
ndc11 (package): 17856631202
spl id: 34f3b398-296a-9e8a-e063-6394a90a74d5
spl set id: 73aede9d-37dd-4aa5-a906-0e0c94cecff1

Reported adverse events (FAERS/openFDA)#

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