FDA.reportPublic FDA data

Mucus Relief ER DM

Product NDC
30142-991
11-digit product format
301420991
Labeler code
30142
Product ID
30142-991_f3f6ac23-76c2-4f25-b13a-8b1915e092f2
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
KROGER COMPANY
Application
NDA021620
Marketing category
NDA
Marketing start
2019-05-30
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
600 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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
30142-991-202022-01-28C16284748780-1d6a99b39-d3dd-a426-e053-dadaa90af4c2Mucus Relief ER DM Extended Release
30142-991-402022-01-28C16284748780-1d6a99b39-d3dd-a426-e053-dadaa90af4c2Mucus Relief ER DM Extended Release

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-991-20Mucus Relief ER DM Extended Release20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE203
30142-991-20Mucus Relief ER DM Extended Release1 in 1 CARTONTABLET, EXTENDED RELEASE13
30142-991-40Mucus Relief ER DM Extended Release2 in 1 CARTONTABLET, EXTENDED RELEASE23
30142-991-40Mucus Relief ER DM Extended Release40 in 1 BLISTER PACKTABLET, EXTENDED RELEASE403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-991MUCUS RELIEF ER DM EXTENDED RELEASE (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [KROGER COMPANY]3Legacy NDC, 4 package rows20200212_33baf963-b29c-4d89-8423-7d91000acae8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN33baf963-b29c-4d89-8423-7d91000acae83
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD33baf963-b29c-4d89-8423-7d91000acae83
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY33baf963-b29c-4d89-8423-7d91000acae83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-991-20301420991201 BLISTER PACK in 1 CARTON (30142-991-20) > 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2019-05-300000-00-00NoNoCurrent
30142-991-40301420991402 BLISTER PACK in 1 CARTON (30142-991-40) > 40 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2019-05-300000-00-00NoNoCurrent