Tussin DM
- Product NDC
- 83324-327
- 11-digit product format
- 833240327
- Labeler code
- 83324
- Product ID
- 83324-327_11cb4fdd-3b49-4cea-b54b-62b3c0095eb2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-02
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20; 200 mg/20mL; mg/20mL
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tussin DM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
| GUAIFENESIN | 200 mg/20mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83324-327-04 | Tussin DM | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 83324-327-04 | Tussin DM | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 2 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Lil' Drug Store Products, Inc. | e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b | 2023-10-02 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | PD-Rx Pharmaceuticals, Inc. | ac8c0c15-b305-47f2-8712-e4b53636f7fa | 2023-10-02 | Warnings | M012 |
| Maximum strength Day cold and flu and Night severe cold and flu | ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS | TIME CAP LABORATORIES,INC | fff69901-965c-5372-e053-6394a90a29c2 | 2023-09-18 | Warnings | M012 |
| Tussin Mucus and Chest Congestion Sugar Free | GUAIFENESIN | AARNA USA, Inc. | 6e488782-0138-436d-a9f0-0ec5bc9daedd | 2023-05-15 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | KROGER COMPANY | 813b1db2-a177-77c6-e053-2a91aa0ac73b | 2023-01-17 | Warnings | M012 |
| MUCUS RELIEF DM | DEXTROMETHORPHAN HBR/GUAIFENESIN | KROGER COMPANY | 813baf42-edb0-33a9-e053-2a91aa0a8599 | 2023-01-17 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H-E-B | db19b8c7-0334-0664-e053-2a95a90ad61f | 2023-01-14 | Warnings | M012 |
| Nightime | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | H-E-B | db44560b-da02-74c9-e053-2a95a90af0b6 | 2023-01-13 | Warnings | M012 |
| DAYTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | dbf5656b-9105-871b-e053-2995a90a4941 | 2023-01-03 | Warnings | M012 |
| DAYTIME-NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | KROGER | a2508699-08c0-4a22-e053-2a95a90a8a6d | 2022-11-02 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | PAI Holdings, LLC dba PAI Pharma | c2e53fb5-2798-47c8-9285-d1077d46e629 | 2022-06-14 | Warnings | M012 |
| Mucus Relief DM | MUCUS RELIEF DM | TopCo Associates, LLC | 71674a9b-89ed-43d1-aadb-b9311fdfbdf9 | 2022-06-07 | Warnings | M012 |
| Daytime Nighttime Cold and Flu Relief Combo Pack | DAYTIME NIGHTTIME COLD AND FLU | Allegiant Health | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 2022-05-19 | Warnings | M012 |
| Mucus Relief DM Immediate Release | MUCUS RELIEF DM | Good Sense | 26a199bf-57e5-4f36-b40c-83a1187e4870 | 2022-05-18 | Warnings | M012 |
| Mucus Relief DM Immediate Release | MUCUS RELIEF DM | Allegiant Health | 731f8608-ad5b-491e-a4d4-2bb0c423fed5 | 2022-05-18 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b3c229a4-c772-70fb-e053-2a95a90a72db | 2022-03-11 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Good Sense | f88e2654-8e97-4cf6-9c36-01aeb51a9102 | 2021-11-30 | Warnings | M012 |
| Cold Medicine | COLD MEDICINE | Allegiant Health | 443fbc44-2c33-4316-ad31-dcc5a5aa8f52 | 2021-11-23 | Warnings | M012 |
| Decongestant PE Non Drowsy | PHENYLEPHRINE HCL | Allegiant Health | 7a3098b4-381c-4f32-97a7-87b53fd64428 | 2021-06-16 | Warnings | M012 |
| Mucus Relief Immediate Release | GUAIFENESIN 400MG | Good Sense | e7c68746-7ec0-46cf-b4a3-174fab819b5e | 2021-05-05 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1790650 | dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution | PSN | 9c9403b9-67cd-4072-a165-a67b568786be | 2 |
| 1790650 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution | SCD | 9c9403b9-67cd-4072-a165-a67b568786be | 2 |
| 1790650 | dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution | SY | 9c9403b9-67cd-4072-a165-a67b568786be | 2 |
| 1790650 | dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution | SY | 9c9403b9-67cd-4072-a165-a67b568786be | 2 |
| 1790650 | dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral Solution | SY | 9c9403b9-67cd-4072-a165-a67b568786be | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 83324-327-04 | 83324032704 | 1 BOTTLE, PLASTIC in 1 CARTON (83324-327-04) / 118 mL in 1 BOTTLE, PLASTIC | 2025-09-02 | No | No | Current |