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 |
|---|---|---|---|---|---|---|
| nasal decongestant maximum strength non drowsy | PSEUDOEPHEDRINE HCL | Meijer Distribution Inc | 8a68ca99-fd76-409a-9769-88830e8720a8 | 2024-09-28 | Warnings | M012 |
| good neighbor pharmacy tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amerisource Bergen | 58687394-b6d2-4d51-bde0-8f2cfa3fe909 | 2024-09-27 | Warnings | M012 |
| good neighbor pharmacy nasal | OXYMETAZOLINE HYDROCHLORIDE | Amerisource Bergen | faee3aae-e819-4084-a127-3449be353b13 | 2024-09-27 | Warnings | M012 |
| Tesalon Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL | OPMX LLC | 2309620a-ccbc-41e9-e063-6394a90a9520 | 2024-09-26 | Warnings | M012 |
| adult cough and chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Meijer, Inc. | b11c4cee-bbb5-4585-9d38-6787553e13a0 | 2024-09-26 | Warnings | M012 |
| COLD AND FLU NIGHTTIME SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9c34e-a0ca-cdf9-e053-2a95a90a93d3 | 2024-09-25 | Warnings | M012 |
| Basic Care Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | 8f3317f6-4ae8-474b-93c3-25e256519cb8 | 2024-09-25 | Warnings | M012 |
| berkley and jensen tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | BJWC | b2de91c9-6af0-4881-8d2d-a69d90c8dfcd | 2024-09-24 | Warnings | M012 |
| Tussin DM Cough and Chest Non Drowsy | DEXTROMETHORPHAN HBR, GUAIFENESIN | WinCo Foods, LLC | 13eb459c-3075-4038-8062-9ee7175b2ab9 | 2024-09-24 | Warnings | M012 |
| equaline nasal decongestant non drowsy maximum strength | PSEUDOEPHEDRINE HCL | United Natural Foods, Inc. dba UNFI | 8897580a-709a-4643-8264-ad003d90cbff | 2024-09-22 | Warnings | M012 |
| Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Dabur India Limited | 22916978-303d-e62a-e063-6394a90a2100 | 2024-09-20 | Warnings | M012 |
| Topcare Nasal Decongestant Maximum Strength Non Drowsy | PSEUDOEPHEDRINE HCL | Topco Associates LLC | 1a9e0336-c0c2-43f8-aeea-668d4a209714 | 2024-09-20 | Warnings | M012 |
| Leader Nasal Decongestant | PSEUDOEPHEDRINE HCL | Cardinal Health 110, LLC. dba Leader | 25609b66-047c-46e7-bc95-20eb8e6c9617 | 2024-09-20 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | CVS Pharmacy | bebe5e78-09ba-4d35-9d34-9f5e34341478 | 2024-09-20 | Warnings | M012 |
| equaline nasal | PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 67fdd277-7a7a-4404-8ca2-39802c46405f | 2024-09-20 | Warnings | M012 |
| equaline tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | 8bc7fa7c-d565-48c9-9808-1042c3e9d428 | 2024-09-20 | Warnings | M012 |
| Leader Adult Tussin Mucus and Chest Congestion 541 | GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | d7fae410-9c1c-4231-9fde-2c51ad3d7e95 | 2024-09-20 | Warnings | M012 |
| sinus | PSEUDOEPHEDRINE HYDROCHLORIDE | Kroger Company | 18812f2a-9b66-45a7-9631-123da6fd1c1f | 2024-09-20 | Warnings | M012 |
| Good Sense Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 930469c1-384c-4440-b3e6-9dcd674871c4 | 2024-09-19 | Warnings | M012 |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 2024-09-17 | 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 |