Dextromethorphan HBr 15 mg
- Product NDC
- 53345-028
- 11-digit product format
- 533450028
- Labeler code
- 53345
- Product ID
- 53345-028_27c7d4dd-19bc-29a9-e063-6394a90abcb1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-12-10
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 15 mg/1
- Pharmacologic classes
- 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
- Dextromethorphan HBr 15 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1090487 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ffc7e1e2-b664-461b-963d-764bad2f983f | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-028-01 | Dextromethorphan HBr 15 mg | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 3 | |
| 53345-028-01 | Dextromethorphan HBr 15 mg | 12000 in 1 BAG | CAPSULE, LIQUID FILLED | 12000 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53345-028 | DEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241127_ffc7e1e2-b664-461b-963d-764bad2f983f.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 |
|---|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Health Pharma USA LLC | 319e84fd-4033-f5eb-e063-6394a90aa2f3 | 2026-06-27 | Warnings | M012 |
| HyVee Cough Drops Menthol | MENTHOL | HY-VEE, INC | 47a6f3c3-a6fa-dd61-e063-6394a90a4965 | 2026-06-26 | Warnings | M012 |
| HyVee Cough Drops Cherry | MENTHOL | HY-VEE, INC | 47a717e9-56b3-e771-e063-6394a90a5c17 | 2026-06-26 | Warnings | M012 |
| Calmco Allergy Relief | DIPHENHYDRAMINE HCL | CalmCo LLC | 5532fd37-cdd6-97ab-e063-6394a90a3c77 | 2026-06-26 | Warnings | M012 |
| Dr Kids Allergy Relief | DIPHENHYDRAMINE HCL | CalmCo LLC | 5533e705-b8d5-71cf-e063-6394a90a2010 | 2026-06-26 | Warnings | M012 |
| Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 265f1ce7-160c-4dda-b2e0-b78d68f962bd | 2026-06-26 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | ee052b39-1658-4071-b081-5433c87b5e4a | 2026-06-25 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | DOLGENCORP, LLC | fae1499a-7029-4208-8436-4d330347b915 | 2026-06-25 | Warnings | M012 |
| Sinus Pressure and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | 4fe8f124-ac80-40b4-8e1d-96709c459a4f | 2026-06-25 | Warnings | M012 |
| Allergy and Sinus Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 91268cd0-c151-4744-a715-a57af3f3a314 | 2026-06-25 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea | 2026-06-24 | Warnings | M012 |
| Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | cb475e7f-aec1-415d-9770-07cce4e02c07 | 2026-06-24 | Warnings | M012 |
| Broncolito Children | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 509f5b72-9894-ef44-e063-6394a90a6d07 | 2026-06-23 | Warnings | M012 |
| Neo-Synephrine Severe | PHENYLEPHRINE HYDROCHLORIDE | BF ASCHER AND CO INC | 54edaff7-d241-dc90-e063-6294a90ac64d | 2026-06-23 | Warnings | M012 |
| AXIV Sinus Severe Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE. | VIVUNT PHARMA LLC | 4b81abf9-3ea7-e996-e063-6394a90a71e8 | 2026-06-23 | Warnings | M012 |
| AXIV Sinus OVERNIGHT | OXYMETAZOLINE HYDROCHLORIDE. | VIVUNT PHARMA LLC | 54e03a63-f978-33d4-e063-6394a90a30f2 | 2026-06-23 | Warnings | M012 |
| equaline daytime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 9a199782-5d7e-449b-a86c-969746f0e96f | 2026-06-23 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Walgreen Company | 542b9861-8055-45f6-8cbf-9fe5cde1c4d9 | 2026-06-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | BIONPHARMA INC. | 3c1953a1-32e9-6c81-e063-6294a90a9fa2 | 2026-06-22 | Warnings | M012 |
| DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 59db2573-7ebb-4cf9-bfe3-428929bb4eeb | 2026-06-22 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1090487 | dextromethorphan HBr 15 MG Oral Capsule | PSN | ffc7e1e2-b664-461b-963d-764bad2f983f | 3 |
| 1090487 | dextromethorphan hydrobromide 15 MG Oral Capsule | SCD | ffc7e1e2-b664-461b-963d-764bad2f983f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-028-01 | 53345002801 | 1 BAG in 1 BOX (53345-028-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2014-12-10 | 0000-00-00 | No | No | Current |