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 |
|---|---|---|---|---|---|---|
| Sinus and Headache Daytime | ACETAMINOPHEN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | 869e950c-5861-4840-aaad-b0342790d62b | 2026-02-10 | Warnings | M012 |
| CareOne Night TIme Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | American Sales Company | d6b9fb27-3ef7-47ee-81f2-b9a3ccd6de25 | 2026-02-10 | Warnings | M012 |
| Medique Cold Cough Product | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , | Sportpharm LLC | d61df3a4-8ae2-46b1-b322-7f4e04cc1bf9 | 2026-02-09 | Warnings | M012 |
| Sinus Congestion and Pain Daytime | ACETAMINOPHEN AND PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | f3fc270a-92fc-46d5-b187-44e875c3abb9 | 2026-02-09 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | d5c8b248-6d82-4eac-881c-0b9d0a0de8f1 | 2026-02-09 | Warnings | M012 |
| DayTime/NiteTime Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | d07112dd-27df-46cc-b7c3-af8ba7601d06 | 2026-02-09 | Warnings | M012 |
| TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 48f7933e-6582-638c-e063-6394a90abfe5 | 2026-02-06 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Retail Business Services, LLC | 4fb46860-2bf9-41a7-89eb-31c259c61107 | 2026-02-06 | Warnings, Adverse reactions | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | Sportpharm LLC | 909dacfa-50d3-4bcf-b2df-5405427cfaad | 2026-02-06 | Warnings | M012 |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | Sportpharm LLC | f91b7c1f-e074-4767-b9c8-dbf1937a6a0f | 2026-02-06 | Warnings | M012 |
| Severe Allergy And Sinus Headache Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy | b3c744b8-aa93-505d-f8cf-07995da4283d | 2026-02-06 | Warnings | M012 |
| NightTime Cold and Flu Multi Symptom | ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 911e6a51-c0f0-491a-b70c-00011ed5e35b | 2026-02-06 | Warnings | M012 |
| Severe Sinus Daytime, Non-Drowsy | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | cc0dc951-5024-4517-9d38-a01699407e7e | 2026-02-06 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Pharmacy Value Alliance, LLC | d836c3e2-3b69-41f3-b166-21270550e8ab | 2026-02-05 | Warnings, Adverse reactions | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Publix Super Markets, Inc. | 81b1d5bb-f813-4f79-9559-2494db33ad3c | 2026-02-05 | Warnings, Adverse reactions | M012 |
| Nasal | OXYMETAZOLINE HYDROCHLORIDE | Kroger Company | 6499f854-2995-48cb-9c80-be6524b3db43 | 2026-02-05 | Warnings | M012 |
| Cold and Flu plus Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALMART INC. | 52a398eb-e593-458b-9c42-6f653ca391be | 2026-02-04 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Hy-Vee, Inc. | 446de381-6685-748d-e063-6394a90a1b73 | 2026-02-04 | Warnings, Adverse reactions | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 85aadc86-d979-41a1-849a-e2ccc9014429 | 2026-02-04 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | fa8c154c-56c6-47de-8e43-9e012b4be95f | 2026-02-04 | 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 |