Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
51660-054
11-digit product format
516600054
Labeler code
51660
Product ID
51660-054_7e0db0cc-7fda-45f6-959c-a9c2f6d2066b
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
OHM LABORATORIES INC
Application
NDA021620
Marketing category
NDA
Marketing start
2019-10-01
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
600 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-054-412022-01-28C16284748780-1d6a99b39-b940-a426-e053-dadaa90af4c2Guaifenesin 600 mg & Dextromethorphan HBr 30 mg Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-054-41Guaifenesin and Dextromethorphan Hydrobromide1 in 1 CARTONTABLET, EXTENDED RELEASE11
51660-054-41Guaifenesin and Dextromethorphan Hydrobromide40 in 1 BLISTER PACKTABLET, EXTENDED RELEASE401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-054GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [OHM LABORATORIES INC]1Legacy NDC, 2 package rows20191004_eaea42f3-c119-4f41-8be2-33e3ebceccf6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNeaea42f3-c119-4f41-8be2-33e3ebceccf61
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDeaea42f3-c119-4f41-8be2-33e3ebceccf61
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYeaea42f3-c119-4f41-8be2-33e3ebceccf61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-054-41516600054411 BLISTER PACK in 1 CARTON (51660-054-41) > 40 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2019-10-010000-00-00NoNoCurrent