Maximum Strength-Cough and Chest Congestion DM
- Product NDC
- 53345-034
- 11-digit product format
- 533450034
- Labeler code
- 53345
- Product ID
- 53345-034_27c8006d-0566-29d6-e063-6394a90a7054
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Maximum Strength-Cough and Chest Congestion DM
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-06-30
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10; 200 mg/1; mg/1
- 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
- 2026-12-31
- 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
- Maximum Strength-Cough and Chest Congestion DM
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1111663 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d1830989-fe82-4f08-8618-78979fcef568 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 53345-034-01 | Maximum Strength-Cough and Chest Congestion DM | 4000 in 1 BAG | CAPSULE, LIQUID FILLED | 4000 | 3 | |
| 53345-034-01 | Maximum Strength-Cough and Chest Congestion DM | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53345-034 | MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241127_d1830989-fe82-4f08-8618-78979fcef568.zip |
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 |
|---|---|---|---|---|---|---|
| Cherry Cough Drop | MENTHOL | Safeway Inc. | 4a52c0c2-8659-2819-e054-00144ff8d46c | 2025-12-20 | Warnings | M012 |
| Signature Care Cherry Cough Drops | MENTHOL | Safeway | a733e905-af15-d3ea-e053-2a95a90aa7c3 | 2025-12-20 | Warnings | M012 |
| Signature Care Honey Lemon Cough Drops | MENTHOL | Safeway | a742449f-c76b-2b91-e053-2a95a90ae4d2 | 2025-12-20 | Warnings | M012 |
| Cherry Sore Throat Lozenge | BENZOCAINE | TopCo | 60b876e7-c642-5ce8-e053-2a91aa0abd6e | 2025-12-20 | Warnings | M012 |
| menthol cough drops | MENTHOL | Topco Associates | 366cc6b1-beff-29d2-e054-00144ff88e88 | 2025-12-20 | Warnings | M012 |
| cherry cough drops | MENTHOL | TopCo Associates | 3fef2117-7311-1e66-e054-00144ff8d46c | 2025-12-20 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | Topco Associates | 3ff1bf05-e407-3b67-e054-00144ff8d46c | 2025-12-20 | Warnings | M012 |
| sugar free menthol cough drops | MENTHOL | Topco Associates | 36727f0c-d6d2-28a3-e054-00144ff8d46c | 2025-12-20 | Warnings | M012 |
| sugar free honey lemon cough drops | MENTHOL | Topco Associates | 36824bee-607e-7095-e054-00144ff8d46c | 2025-12-20 | Warnings | M012 |
| Mixed Berry Sore Throat Lozenges | BENZOCAINE | Topco Associates | 7a00c771-9231-e877-e053-2a91aa0ac96e | 2025-12-20 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | NUVICARE LLC | e25b440e-f389-443f-b333-c66ad1747158 | 2025-12-19 | Warnings | M012 |
| Cold and Flu severe | ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 | 2025-12-19 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Geiss, Destin & Dunn Inc. | a7d2eaee-484e-43aa-8ae3-0e050219383f | 2025-12-19 | Warnings | M012 |
| Cherry Cough Drops | MENTHOL | Publix | 66d8e5f7-9766-57f3-e053-2991aa0a7e17 | 2025-12-19 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Publix | 66e89fa3-ee09-1d16-e053-2a91aa0ae17c | 2025-12-19 | Warnings | M012 |
| Poly-Vent DM | DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | 739329ae-0b62-4eab-a07d-867b5d3d61e0 | 2025-12-19 | Warnings | M012 |
| Chest Congestion and Cough Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | ARMY AND AIR FORCE EXCHANGE SERVICE | 89494a7c-cdbf-48f1-aaa9-2e57d4388a68 | 2025-12-19 | Warnings | M012 |
| DayTime Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 04f9134e-1311-4843-90db-9244b9e61e1d | 2025-12-19 | Warnings | M012 |
| Nighttime Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 029e6215-b72d-4fd0-8918-db1abcc4490a | 2025-12-19 | Warnings | M012 |
| DayTime and Nighttime Cold/Flu Relief Softgels - Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 5f680f37-b3db-450f-b8ca-f9e31a04dc04 | 2025-12-19 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1111663 | dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral Capsule | PSN | d1830989-fe82-4f08-8618-78979fcef568 | 3 |
| 1111663 | dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral Capsule | SCD | d1830989-fe82-4f08-8618-78979fcef568 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-034-01 | 53345003401 | 1 BAG in 1 BOX (53345-034-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2015-06-30 | 0000-00-00 | No | No | Current |