FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
30142-706
11-digit product format
301420706
Labeler code
30142
Product ID
30142-706_0beaf383-d8ad-45ab-a8ab-a894edb01b3b
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
2017-09-05
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
1200 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
30142-706-142022-01-28C16284748780-1d6a99b39-4daf-a426-e053-dadaa90af4c2Guaifenesin and Dextromethorphan Hydrobromide
30142-706-282022-01-28C16284748780-1d6a99b39-4daf-a426-e053-dadaa90af4c2Guaifenesin and Dextromethorphan Hydrobromide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-706-14Guaifenesin and Dextromethorphan Hydrobromide1 in 1 CARTONTABLET, EXTENDED RELEASE14
30142-706-14Guaifenesin and Dextromethorphan Hydrobromide14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE144
30142-706-28Guaifenesin and Dextromethorphan Hydrobromide2 in 1 CARTONTABLET, EXTENDED RELEASE24
30142-706-28Guaifenesin and Dextromethorphan Hydrobromide14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-706GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [KROGER COMPANY]4Legacy NDC, 4 package rows20200212_3976d0dc-1f74-4d5e-a5b8-0a3e3ce5cfc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN3976d0dc-1f74-4d5e-a5b8-0a3e3ce5cfc34
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD3976d0dc-1f74-4d5e-a5b8-0a3e3ce5cfc34
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY3976d0dc-1f74-4d5e-a5b8-0a3e3ce5cfc34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-706-14301420706141 BLISTER PACK in 1 CARTON (30142-706-14) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2017-09-050000-00-00NoNoCurrent
30142-706-28301420706282 BLISTER PACK in 1 CARTON (30142-706-28) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-09-050000-00-00NoNoCurrent