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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HCL | CVS Pharmacy | eafd9823-c0ad-454a-b725-562d88ebec92 | 2026-03-23 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4db0470b-1bf0-9137-e063-6394a90a1d54 | 2026-03-23 | Warnings | M012 |
| Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4db066d4-ddbe-ddce-e063-6394a90ac5f8 | 2026-03-23 | Warnings | M012 |
| Throat Comfort Orange Mint Cinnamon Drops | MENTHOL | Ricola Ag | 27487e5c-044c-41eb-865f-2f34351afd52 | 2026-03-23 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | f288eeca-9803-4962-a802-fe34f5983c7a | 2026-03-23 | Warnings | M012 |
| Throat Comfort Lemon Mint Ginger Drops | MENTHOL | Ricola Ag | d63b4d24-e926-418c-bb17-420aeaad5a62 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Congestion Cough Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 6e7dfee1-3de9-46c8-9b58-83fcf8ee72e0 | 2026-03-23 | Warnings | M012 |
| Maximum Strength Mucus Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | Hyvee Inc | 44eafc83-8e7b-89b8-e063-6394a90ab0bc | 2026-03-23 | Warnings | M012 |
| Throat Comfort Lemon Mint Ginger Drops | MENTHOL | Ricola USA Inc. | 5d7889b1-3866-49b0-97e1-1e883a52d3cb | 2026-03-23 | Warnings | M012 |
| Throat Comfort Orange Mint Cinnamon Drops | MENTHOL | Ricola USA Inc. | 1487652c-dbc1-40f4-9d59-891ec74cc363 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4e2a8b53-0074-42fd-8357-a39cc6afe608 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Severe Cold Daytime Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET Corporation | 5ccaf3b0-096a-4644-9c6e-9f251c167b3c | 2026-03-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4d88180f-610c-d9ab-e063-6394a90a09f0 | 2026-03-21 | Warnings | M012 |
| Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | HyVee Inc | cc371bc3-ba7a-430d-9ee4-22e9c50935f1 | 2026-03-20 | Warnings | M012 |
| Daytime Nighttime Multi Symptom Cold Childrens | DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreens | da4c36f5-ec79-4489-bb18-8ddab79c34bd | 2026-03-20 | Warnings | M012 |
| Sanatos Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Pharmadel LLC | 3bddcd5a-7776-49ff-e063-6294a90a5dd1 | 2026-03-20 | Warnings | M012 |
| Vaporizing | CAMPHOR | Amazon.com Services LLC | 21cfe9cb-5ff5-4331-8358-4d1d9646d6ac | 2026-03-19 | Warnings, Adverse reactions | M012 |
| Equate Wild Cherry Throat Drop | PECTIN | Walmart | 4d66547a-b72a-a0ac-e063-6394a90adc71 | 2026-03-19 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Safeway, Inc. | 45d44cd2-5187-4a5c-983a-edb1e8eba0b2 | 2026-03-19 | Warnings | M012 |
| Sedalmex XL Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Belmora LLC | f2edfedf-e06e-4d1b-8c2d-732e08ec113c | 2026-03-19 | 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 |