(U.S. Department of Health and Human Resources: FDA)
Unapproved Prescription Cough, Cold, and Allergy Products
The drug products on this list were obtained from the Drug Registration and Listing System (DRLS) in December 2010. For more DRLS Information1.
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register and list all of their commercially marketed drug products with the FDA (21 U.S.C. § 360 and 21 CFR 207). Many drug firms do not update their drug listing information with FDA as required by law; consequently, the information in DRLS is both over- and under-inclusive. Therefore, the list above of unapproved prescription cough/cold/allergy drug products may include drugs that are no longer being marketed and/or may not include prescription cough/cold/allergy drug products that are currently being marketed if the drug firm has not listed or updated their information with DRLS. Any unapproved prescription oral cough/cold/allergy drugs that are not on this list are not entitled to any grace period and are subject to immediate enforcement action.
** Incomplete information was submitted to FDA’s Drug Registration and Listing system
(For the complete list, visit the FDA website: Unapproved Prescription Cough, Cold, and Allergy Medications.
| NAME OF DRUG | INGREDIENTS | Strength | NDC Labeler Code | NDC Product Code |
|---|---|---|---|---|
| A TAN 12X SUSPENSION | PYRILAMINE TANNATE | 30 MG | 65162 | 0530 |
| PHENYLEPHRINE TANNATE | 5 MG | |||
| ACCUHIST DM | GUAIFENESIN | 50 MG | 66346 | 0111 |
| DEXTROMETHORPHAN | 5 MG | |||
| PSEUDOEPHEDRINE | 30 MG | |||
| BROMPHENIRAMINE | 2 MG | |||
| ACCUHIST DROPS CHERRY FLAVOR | CHLORPHENIRAMINE MALEATE | 0.8 MG | 23589 | 0004 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 9 MG | |||
| AEROHIST CAPLETS EXTENDED RELEASE | CHLORPHENIRAMINE MALEATE | 8 MG | 038739 | *082 |
| METHSCOPOLAMINE NITRATE | 2.5 MG | |||
| AEROHIST EXTENDED RELEASE TABLETS | CHLORPHENIRAMINE | 8 MG | 66440 | 0082 |
| METHSCOPOLAMINE NITRATE | 2.5 MG | |||
| AEROHIST PLUS EXTENDED RELEASE CAPLETS | CHLORPHENIRAMINE MALEATE | 8 MG | 066440 | 2376 |
| METHSCOPOLAMINE NITRATE | 2.5 MG | |||
| PHENYLEPHRINE HYDROCHLORIDE | 20 MG | |||
| AH CHEW SUSPENSION | CHLORPHENIRAMINE TANNATE | 35 MG | 59196 | 0015 |
| PHENYLEPHRINE TANNATE | 25 MG | |||
| AH CHEW ULTRA CHEWABLE TABLET | CHLORPHENIRAMINE TANNATE | 10 MG | 59196 | 0115 |
| PHENYLEPHRINE TANNATE | 2 MG |