Maximum Strength-Cough and Chest Congestion DM
- Product NDC
- 53345-034
- Requested package NDC
- 53345-034-01
- 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 |
|---|---|---|---|---|---|---|
| Severe Sinus Relief Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 847f47d9-62b1-49a3-8bb3-9bf275685bd2 | 2024-02-14 | Warnings | M012 |
| Allergy Sinus, Lil Drug Store | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE | Lil' Drug Store Products, Inc. | 1145440e-b37a-6e5e-e063-6294a90ab4a0 | 2024-02-13 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | A-S Medication Solutions | 36140639-e7a8-43bc-83e2-469430af9d1a | 2024-02-13 | Warnings | M012 |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | ff48b55a-0d32-47d6-941d-d99c7cf52f94 | 2024-02-12 | Warnings | M012 |
| Childrens Robitussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 15950273-14c9-4a0b-bbb4-683048add722 | 2024-02-08 | Warnings | M012 |
| THERAFLU Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 7d902237-a990-4c5e-875b-291e124e143b | 2024-02-03 | Warnings | M012 |
| Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 0f2d371d-f890-41e5-ac11-db5559d32466 | 2024-02-02 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 4daca846-8511-4303-9e6c-9469f7f260ba | 2024-02-02 | Warnings | M012 |
| CVS Health COUGH SUPPRESSANT SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE | CVS Pharmacy, Inc. | f676dfeb-fba8-419d-8a47-c3880e4100cc | 2024-02-02 | Warnings | M012 |
| Nighttime Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 155a7168-b568-41f4-b8a2-214889b4eccf | 2024-02-02 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | Rejoice International Corp. | 104e1a38-3472-b9e2-e063-6294a90a38cf | 2024-02-01 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 104f5b07-eed2-566c-e063-6294a90a6505 | 2024-02-01 | Warnings | M012 |
| CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 5962a73e-72e4-493b-94a7-43bc6cf9c82f | 2024-02-01 | Warnings | M012 |
| good sense allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | L. Perrigo Company | 2cfa69b4-e33f-442a-a6df-b021b041da14 | 2024-02-01 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2024-01-31 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 17a07d2d-f2da-4e51-9a77-6f0c174987bb | 2024-01-31 | Warnings | M012 |
| Maximum strength Max Cold and Sinus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 2024-01-31 | Warnings | M012 |
| THERAFLU POWERPODS NIGHTTIME SEVERE COLD | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 39f9feef-4bf2-4f10-9fff-22bbb1d8a471 | 2024-01-30 | Warnings | M012 |
| Theraflu Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | c0689223-5c90-4dbc-bbfa-f94e267504c3 | 2024-01-28 | Warnings | M012 |
| THERAFLU MULTI-SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | a4c56ca0-7785-404b-996d-137cc135f270 | 2024-01-28 | 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 |