FDA.reportPublic FDA data

cough dm

Product NDC
17856-6312
11-digit product format
178566312
Labeler code
17856
Product ID
17856-6312_34f3b398-296a-9e8a-e063-6394a90a74d5
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA091135
Marketing category
ANDA
Marketing start
2012-09-06
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
cough dm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1373045

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN73aede9d-37dd-4aa5-a906-0e0c94cecff16
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD73aede9d-37dd-4aa5-a906-0e0c94cecff16
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY73aede9d-37dd-4aa5-a906-0e0c94cecff16
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY73aede9d-37dd-4aa5-a906-0e0c94cecff16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-6312-1178566312015 mL in 1 CUP (17856-6312-1) 5 ml2024-11-180000-00-00NoNoCurrent
17856-6312-21785663120210 mL in 1 CUP (17856-6312-2) 10 ml2024-11-180000-00-00NoNoCurrent