FDA.reportPublic FDA data

Mucinex DM

Product NDC
17856-0056
11-digit product format
178560056
Labeler code
17856
Product ID
17856-0056_b8a497cb-5611-4f87-834b-0ac4d3e287a7
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
NDA021620
Marketing category
NDA
Marketing start
2012-06-26
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
600 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0056-12024-05-08C16284748780-1f386c64a-2856-0266-e053-dadaa90a7c1aMucinex DM
17856-0056-12023-01-30C16284748780-1f386c64a-2856-0266-e053-dadaa90a7c1aMucinex DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0056-1Mucinex DM1 in 1 PACKAGETABLET, EXTENDED RELEASE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0056MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC, 1 package rows20240509_02be2813-9584-4d7a-98c9-ad591ea246be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN02be2813-9584-4d7a-98c9-ad591ea246be4
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD02be2813-9584-4d7a-98c9-ad591ea246be4
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY02be2813-9584-4d7a-98c9-ad591ea246be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0056-1178560056011 TABLET, EXTENDED RELEASE in 1 PACKAGE (17856-0056-1) 2021-01-120000-00-00NoNoCurrent