Guaifenesin and Dextromethorphan Oral Solution

Product NDC
0904-6844
11-digit product format
009046844
Labeler code
0904
Product ID
0904-6844_d35bd4cf-bc58-856a-e053-2995a90a5d11
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin Dextromethorphan hydrobromide Oral Solution
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-09-20
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/5mL; mg/5mL
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
0904-6844-702022-09-23C16284748780-1e4f33bdf-ac2e-d8a0-e053-dadaa90a6e4e9247ea9f-3df1-ef4c-e053-2995a90aab15
0904-6844-702022-07-29C16284748780-1e4f33bdf-ac2e-d8a0-e053-dadaa90a6e4e9247ea9f-3df1-ef4c-e053-2995a90aab15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6844-70ML - Milliliter0904-68448fa8728c-7ade-4e15-a52a-eb965f8c5d4612019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6844-700090468447010 TRAY in 1 CARTON (0904-6844-70) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE10 tray2019-09-200000-00-00NoNoCurrent