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 |
|---|---|---|---|---|---|---|
| NightTime Sinus | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | 0f3b1404-9252-470a-aa8c-b360c85731f3 | 2024-11-25 | Warnings | M012 |
| Maximum Strength-Cough and Chest Congestion DM | MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | d1830989-fe82-4f08-8618-78979fcef568 | 2024-11-25 | Warnings | M012 |
| ASP Daytime PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | b84f2392-0b24-4af0-80f7-c45454093f51 | 2024-11-25 | Warnings | M012 |
| ASP Nighttime Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | d8756d1f-baf5-412d-a493-a1c051eae302 | 2024-11-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 508a65ee-42fa-4c0b-b24d-9faac6b0eba7 | 2024-11-24 | Warnings | M012 |
| DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | cb68eef0-b027-4bf1-b78f-f31844a8c06c | 2024-11-22 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | de2a64ce-c169-4162-b79e-d3809bea2147 | 2024-11-22 | Warnings | M012 |
| 12 Hour Nasal Decongestant Extra Moisturizing | NASAL SPRAY | WinCo Foods LLC | 13fbde45-958c-455f-b766-f6a34342ee95 | 2024-11-21 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | a01abac3-c13e-40f2-ae98-34bd6c9b7504 | 2024-11-21 | Warnings | M012 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6 | 2024-11-21 | Warnings | M012 |
| Dextromethorphan HBr 15 mg | DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 028b025e-2dde-4bef-ba7b-61774e855b4b | 2024-11-21 | Warnings | M012 |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | 856cb3c3-8f32-4285-8c13-25f01779a31a | 2024-11-21 | Warnings | M012 |
| Night Time Severe Cold and Flu Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 3375a059-2939-438e-92b5-a7f1952bbb22 | 2024-11-21 | Warnings | M012 |
| NiteTime Cold/Flu, Multi-Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 9033bf94-f444-4488-b717-050d04dee388 | 2024-11-21 | Warnings | M012 |
| Day and Night Sinus Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores, Inc. | 4b554ce8-9a6a-444f-b5ea-63359bbc0653 | 2024-11-21 | Warnings | M012 |
| Day Severe Cold and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores, Inc. | 7492b381-9eca-4b07-b356-63fdaea14f81 | 2024-11-21 | Warnings | M012 |
| Severe sinus Congestion Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | e173bec9-14df-4535-a023-47d8cda8d4ec | 2024-11-21 | Warnings | M012 |
| COLD FLU and SORE THROAT RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 1161e5dc-0677-4fb9-964f-971a508098b6 | 2024-11-21 | Warnings | M012 |
| Night Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Retail Business Services, LLC | fc8c70d6-6be5-4f12-84b0-125fc82149ec | 2024-11-21 | Warnings | M012 |
| 12 Hour Original Nasal Decongestant | NASAL SPRAY | WinCo Foods LLC | b3b6065a-56da-45e9-b89d-f6553bc181c9 | 2024-11-21 | 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 |