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 |
|---|---|---|---|---|---|---|
| Leader Throat Soothing Drops Creamy Strawberry | THROAT SOOTHING CREAMY STRAWBERRY | Cardinal Health 110, LLC. DBA Leader | 26cd146a-6461-604f-e063-6394a90ac36e | 2025-12-22 | Warnings | M012 |
| MGC Health | COUGH DROPS CREAMY STRAWBERRY | Medical Group Care LLC | 043a5e11-30c3-44cd-e063-6394a90a318b | 2025-12-22 | Warnings | M012 |
| MGC Health | COUGH DROPS CHERRY | Medical Group Care LLC | 29f3f6dd-751e-1dfe-e063-6394a90a0dbb | 2025-12-22 | Warnings | M012 |
| MGC Cough Drops | MENTHOL | Medical Group Care LLC | 437f6b77-ecf8-2cd8-e063-6394a90ad45d | 2025-12-22 | Warnings | M012 |
| MGC Health | COUGH DROPS HONEY | Medical Group Care LLC | f4a92a69-e562-1cec-e053-2a95a90a0165 | 2025-12-22 | Warnings | M012 |
| MGC Health | COUGH DROPS VANILLA HONEY | Medical Group Care LLC | 043999bc-3efe-5d29-e063-6294a90a95f4 | 2025-12-22 | Warnings | M012 |
| MGC Health Throat Soothing Drops Creamy Strawberry | PECTIN | Medical Group Care LLC | 3fa195b5-0712-aada-e063-6394a90a9069 | 2025-12-22 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Creamy Strawberry | PECTIN, MENTHOL | Chain Drug Marketing Association, Inc. | 18d28b91-55a7-4d0d-8404-4f21afdef989 | 2025-12-22 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS CHERRY | DISCOUNT DRUG MART | 0668492e-c47e-b7cf-e063-6394a90a309b | 2025-12-22 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS MENTHOL | DISCOUNT DRUG MART | 06574e56-13b8-a3af-e063-6394a90a4867 | 2025-12-22 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS HONEY LEMON | DISCOUNT DRUG MART | 0668ddcc-0214-8e97-e063-6294a90a4f32 | 2025-12-22 | Warnings | M012 |
| caring mill Cough drops CHERRY | MENTHOL | FSA STORE INC. | 9d666061-f7a8-4318-8db1-b65373689e1d | 2025-12-22 | Warnings | M012 |
| Premier Value | COUGH DROPS CHERRY | Pharmacy Value Alliance LLC | 018f4790-8785-94f4-e063-6394a90a1916 | 2025-12-22 | Warnings | M012 |
| Premier Value | COUGH DROPS HONEY LEMON | Pharmacy Value Alliance LLC | 0191fcf7-abc1-e583-e063-6294a90a7854 | 2025-12-22 | Warnings | M012 |
| Premier Value | COUGH DROPS MENTHOL | Pharmacy Value Alliance LLC | 019211bf-dd4b-5f4c-e063-6294a90aacfb | 2025-12-22 | Warnings | M012 |
| Premier Value | COUGH DROPS BLACK CHERRY SUGAR FREE | Pharmacy Value Alliance LLC | 018f20b1-06e0-eb13-e063-6394a90a5ec5 | 2025-12-22 | Warnings | M012 |
| Quality Choice Cherry Cough Drops | CHERRY COUGH DROPS | Chain Drug Marketing Association, Inc. | 6a407092-4b71-4156-b4ad-930782b5fb43 | 2025-12-22 | Warnings | M012 |
| Quality Choice Honey Lemon Cough Drops | HONEY LEMON COUGH DROPS | Chain Drug Marketing Association, Inc. | 1fd09b04-9c79-da20-e063-6394a90ae263 | 2025-12-22 | Warnings | M012 |
| Quality Choice Menthol Cough Drops | MENTHOL COUGH DROPS | Chain Drug Marketing Association, Inc. | 3364470e-d9bb-42a6-9bd5-80c0bed8bc9e | 2025-12-22 | Warnings | M012 |
| Quality Choice Honey Lemon Sugar Free Cough Drops | HONEY LEMON SUGAR FREE COUGH DROPS | Chain Drug Marketing Association, Inc. | 1fd0a790-c67c-216f-e063-6294a90ae971 | 2025-12-22 | 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 |