Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu
acetaminophen, dextromethorphan hydrobromide, guaifenesin
Haleon US Holdings LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1314819 | 1314819 | Haleon US Holdings LLC | 1 | N | 2026-01-01 | 3169 Route 145 East Durham NY US 12423 |
| 1911445 | 1911445 | Haleon US Inc. | 1 | N | 2026-01-01 | 10401 HWY 6 -- Lincoln NE US 68517 |
| 3012293198 | 3012293198 | Haleon US HOLDINGS LLC | 1 | N | 2026-01-01 | 184 LIBERTY CORNER RD Warren NJ US 07059 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 206711 | 1417949907 | K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY | LFD | 2013-01-04 |
| 206711 | 1656416605 | K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF | LFD | 2011-07-20 |
| 206711 | 1842604639 | K061331 | ORAL BALANCE LIQUID/ GEL | LFD | 2006-07-25 |
| 206711 | 1483763338 | DEN220078 | Eroxon | QWW | 2023-06-09 |
| 206711 | 1635559116 | ||||
| 123892 | 1143669791 | ||||
| 206711 | 1143669791 | ||||
| 269845 | 1143669791 | ||||
| 206711 | 1449469601 |
Product Codes Associated With Registrations#
NDC#
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime
acetaminophen, diphenhydramine hcl
Robitussin
dextromethorphan HBr, guaifenesin, doxylamine succinate
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM
dextromethorphan HBr, guaifenesin
Childrens Robitussin Elderberry Cough and Chest Congestion DM
dextromethorphan HBr, guaifenesin
Robitussin
dextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate
Robitussin
dextromethorphan HBr, guaifenesin, doxylamine succinate
Robitussin
dextromethorphan hydrobromide, guaifenesin, doxylamine succinate
Robitussin
dextromethorphan hydrobromide, guaifenesin, doxylamine succinate
Robitussin 12 Hour Cough Relief
dextromethorphan polistirex
Childrens Robitussin Nighttime Cough Long-Acting DM
chlorpheniramine maleate, dextromethorphan hydrobromide
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING
chlorpheniramine maleate, dextrometrorphan HBr
Childrens Robitussin Cough Long-Acting
dextromethorphan hydrobromide
Childrens Robitussin Cough and Chest Congestion DM
dextromethorphan hydrobromide and guaifenesin
Childrens Robitussin Cough and Chest Congestion DM
dextromethorphan hydrobromide, guaifenesin
Childrens Robitussin Cough and Cold CF
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Robitussin Maximum Strength Nighttime Cough DM
dextromethorphan hydrobromide, doxylamine succinate
Robitussin Maximum Strength Cough Plus Chest Congestion DM
dextromethorphan hydrobromide and guaifenesin
Childrens Robitussin 12 Hour Cough Relief
dextromethorphan polistirex
Childrens Robitussin 12 Hour Cough Relief
dextromethorphan polistirex
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
dextromethorphan hbr, guaifenesin
Robitussin Peak Cold Multi-Symptom Cold
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
ROBITUSSIN LONG-ACTING COUGHGELS
dextromethorphan hydrobromide
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate
Robitussin Maximum Strength Severe Cough Plus Sore Throat
acetaminophen, dextromethorphan hydrobromide
Robitussin Severe Multi-Symptom Cough Cold Flu
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
Robitussin 12 Hour Cough Relief
dextromethorphan polistirex
Robitussin 12 Hour Cough Relief
dextromethorphan polistirex
Robitussin 12 Hour Cough Relief
dextromethorphan polistirex
Robitussin Honey Maximum Strength Cough and Chest Congestion DM
dextromethorphan HBr, guaifenesin
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide and guaifenesin
Robitussin Honey Maximum Strength Nighttime Cough DM
dextromethorphan HBr, doxylamine succinate
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM
dextromethorphan hydrobromide, guaifenesin
Childrens Robitussin Honey Cough and Chest Congestion DM
dextromethorphan HBr, guaifenesin
Childrens Robitussin Honey Nighttime Cough DM
dextromethorphan hbr, doxylamine succinate
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief
Dextromethorphan Hydrobromide, Guaifenesin
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime
acetaminophen and diphenhydramine hydrochloride
Robitussin Honey Severe Cough, Flu Plus Sore Throat
acetaminophen, dextromethorphan hbr
Robitussin Direct Sore Throat Pain
acetaminophen
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