| 36800-494-28 |
36800-494 |
HUMAN OTC DRUG |
TopCare Cough DM |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20240808 |
N/A |
ANDA |
ANDA091135 |
Topco Associates LLC |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (36800-494-28) / 148 mL in 1 BOTTLE |
| 51316-429-28 |
51316-429 |
HUMAN OTC DRUG |
CHILDRENS 12 HR COUGH RELIEF |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20260317 |
N/A |
ANDA |
ANDA091135 |
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (51316-429-28) / 148 mL in 1 BOTTLE |
| 70000-0187-1 |
70000-0187 |
HUMAN OTC DRUG |
Leader Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20161205 |
N/A |
ANDA |
ANDA091135 |
Cardinal Health 110, LLC. dba Leader |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (70000-0187-1) / 89 mL in 1 BOTTLE |
| 0031-8753-03 |
0031-8753 |
HUMAN OTC DRUG |
Robitussin 12 Hour Cough Relief |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20150701 |
N/A |
ANDA |
ANDA091135 |
Haleon US Holdings LLC |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (0031-8753-03) / 89 mL in 1 BOTTLE |
| 42507-384-21 |
42507-384 |
HUMAN OTC DRUG |
cough dm |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20120902 |
N/A |
ANDA |
ANDA091135 |
HyVee Inc |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (42507-384-21) / 89 mL in 1 BOTTLE (42507-384-00) |
| 42507-384-28 |
42507-384 |
HUMAN OTC DRUG |
cough dm |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20130805 |
N/A |
ANDA |
ANDA091135 |
HyVee Inc |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (42507-384-28) / 148 mL in 1 BOTTLE (42507-384-01) |
| 0113-0958-21 |
0113-0958 |
HUMAN OTC DRUG |
Good Sense Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20130620 |
N/A |
ANDA |
ANDA091135 |
L. Perrigo Company |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (0113-0958-21) / 89 mL in 1 BOTTLE |
| 0113-0958-28 |
0113-0958 |
HUMAN OTC DRUG |
Good Sense Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20130725 |
N/A |
ANDA |
ANDA091135 |
L. Perrigo Company |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (0113-0958-28) / 148 mL in 1 BOTTLE |
| 41520-384-21 |
41520-384 |
HUMAN OTC DRUG |
CareOne Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20120830 |
N/A |
ANDA |
ANDA091135 |
American Sales Company |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (41520-384-21) / 89 mL in 1 BOTTLE |
| 72288-958-28 |
72288-958 |
HUMAN OTC DRUG |
basic care childrens cough dm |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20210720 |
N/A |
ANDA |
ANDA091135 |
Amazon.com Services LLC |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (72288-958-28) / 148 mL in 1 BOTTLE |
| 55910-384-21 |
55910-384 |
HUMAN OTC DRUG |
DG Health Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20130702 |
N/A |
ANDA |
ANDA091135 |
Dolgencorp Inc |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (55910-384-21) / 89 mL in 1 BOTTLE |
| 0031-8725-10 |
0031-8725 |
HUMAN OTC DRUG |
Childrens Robitussin 12 Hour Cough Relief |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20160705 |
N/A |
ANDA |
ANDA091135 |
Haleon US Holdings LLC |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (0031-8725-10) / 89 mL in 1 BOTTLE |
| 0031-8754-15 |
0031-8754 |
HUMAN OTC DRUG |
Robitussin 12 Hour Cough Relief |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20160705 |
N/A |
ANDA |
ANDA091135 |
Haleon US Holdings LLC |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (0031-8754-15) / 148 mL in 1 BOTTLE |
| 0904-6312-56 |
0904-6312 |
HUMAN OTC DRUG |
cough dm |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20120906 |
N/A |
ANDA |
ANDA091135 |
Major Pharmaceuticals |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (0904-6312-56) / 89 mL in 1 BOTTLE |
| 17856-6312-1 |
17856-6312 |
HUMAN OTC DRUG |
cough dm |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20241118 |
N/A |
ANDA |
ANDA091135 |
ATLANTIC BIOLOGICALS CORP. |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
5 mL in 1 CUP (17856-6312-1) |
| 17856-6312-2 |
17856-6312 |
HUMAN OTC DRUG |
cough dm |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20241118 |
N/A |
ANDA |
ANDA091135 |
ATLANTIC BIOLOGICALS CORP. |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
10 mL in 1 CUP (17856-6312-2) |
| 70000-0195-1 |
70000-0195 |
HUMAN OTC DRUG |
leader childrens cough dm |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20161115 |
N/A |
ANDA |
ANDA091135 |
Cardinal Health 110, LLC. dba Leader |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (70000-0195-1) / 89 mL in 1 BOTTLE |
| 70000-0302-1 |
70000-0302 |
HUMAN OTC DRUG |
Leader Cough DM |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20170606 |
N/A |
ANDA |
ANDA091135 |
Cardinal Health 110, LLC. dba Leader |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (70000-0302-1) / 89 mL in 1 BOTTLE |
| 70000-0302-2 |
70000-0302 |
HUMAN OTC DRUG |
Leader Cough DM |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20260408 |
N/A |
ANDA |
ANDA091135 |
Cardinal Health 110, LLC. dba Leader |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (70000-0302-2) / 148 mL in 1 BOTTLE |
| 41163-384-21 |
41163-384 |
HUMAN OTC DRUG |
equaline cough dm |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20121019 |
N/A |
ANDA |
ANDA091135 |
United Natural Foods, Inc. dba UNFI |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (41163-384-21) / 89 mL in 1 BOTTLE |