FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
11822-7156
11-digit product format
118227156
Labeler code
11822
Product ID
11822-7156_2119f46c-13c8-408f-bd97-220f9ed23e46
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rite-Aid
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-7156-02023-01-30C16284748780-1ba0f9c33-312f-a910-e053-dadaa90a0b85Guaifenesin and Dextromethorphan Hydrobromide
11822-7156-92023-01-30C16284748780-1ba0f9c33-312f-a910-e053-dadaa90a0b85Guaifenesin and Dextromethorphan Hydrobromide
11822-7156-02021-10-22C16284748780-1ba0f9c33-312f-a910-e053-dadaa90a0b85Guaifenesin and Dextromethorphan Hydrobromide
11822-7156-92021-10-22C16284748780-1ba0f9c33-312f-a910-e053-dadaa90a0b85Guaifenesin and Dextromethorphan Hydrobromide
11822-7156-02021-01-29C16284748780-1ba0f9c33-312f-a910-e053-dadaa90a0b85Guaifenesin and Dextromethorphan Hydrobromide
11822-7156-92021-01-29C16284748780-1ba0f9c33-312f-a910-e053-dadaa90a0b85Guaifenesin and Dextromethorphan Hydrobromide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-7156-0Guaifenesin and Dextromethorphan Hydrobromide28 in 1 BLISTER PACKTABLET, EXTENDED RELEASE285
11822-7156-0Guaifenesin and Dextromethorphan Hydrobromide1 in 1 CARTONTABLET, EXTENDED RELEASE15
11822-7156-9Guaifenesin and Dextromethorphan Hydrobromide14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE145
11822-7156-9Guaifenesin and Dextromethorphan Hydrobromide1 in 1 CARTONTABLET, EXTENDED RELEASE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7156GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [RITE-AID]5Legacy NDC, 4 package rows20211023_f02315e9-2ae1-470e-9582-dcaa581c234f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNf02315e9-2ae1-470e-9582-dcaa581c234f5
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDf02315e9-2ae1-470e-9582-dcaa581c234f5
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYf02315e9-2ae1-470e-9582-dcaa581c234f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-7156-0118227156001 BLISTER PACK in 1 CARTON (11822-7156-0) > 28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2017-09-070000-00-00NoNoCurrent
11822-7156-9118227156091 BLISTER PACK in 1 CARTON (11822-7156-9) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2017-09-050000-00-00NoNoCurrent