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 |
|---|---|---|---|---|---|---|
| Good Sense Cherry Benzocaine Lozenges | BENZOCAINE | Geiss, Destin, Dunn | c7404c94-09eb-5cc5-e053-2995a90af021 | 2025-12-12 | Warnings | M012 |
| Good Sense SF Honey Lemon Cough Drops | MENTHOL | Geiss, Destin, Dunn | e11ed21f-6ceb-5908-e053-2995a90aea46 | 2025-12-12 | Warnings | M012 |
| Severe Congestion Relief Maximum Strength Sinus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 59918b8b-5c91-468f-834e-66020dc1ae12 | 2025-12-12 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | SALADO SALES INC. | 8f66f5bc-7c77-420b-9feb-911c980fbfdc | 2025-12-12 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALMART INC. | de55a9fd-53a2-4f3e-82b7-cabcbe287d46 | 2025-12-12 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | SALADO SALES INC. | cc73b668-cc6a-41d6-800a-4988c59c0449 | 2025-12-12 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | CHAIN DRUG MARKETING ASSOCIATION INC | 75269bcc-3bb2-49a0-8788-6b7da18796d3 | 2025-12-12 | Warnings | M012 |
| Suphedrine PE Sinus plus Allergy | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | affac07f-d645-4999-98ee-7467902f5adc | 2025-12-12 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy | ACETAMINOPHEN, PHENYLEPHRINE HCL | WinCo Foods, LLC | f7e925f4-7da6-4157-a97f-e6a3e399911f | 2025-12-11 | Warnings | M012 |
| Sinus Relief Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CARDINAL HEALTH | 645f8075-e33f-4e1a-9249-7368261cdcb9 | 2025-12-11 | Warnings | M012 |
| Geri-Tussin | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 8fd0071b-c6ca-49e6-b159-45dead71b664 | 2025-12-11 | Warnings | M012 |
| Geri-Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 098582dc-3e12-782f-e063-6394a90aa1a1 | 2025-12-11 | Warnings | M012 |
| GUAIASORB DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 09866b9c-aa32-45eb-e063-6394a90a4903 | 2025-12-11 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | d6947661-a6dd-4bc4-a0ca-932db1840f58 | 2025-12-11 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | 2e751d67-51b4-4b74-a9e8-7f3bc5636984 | 2025-12-11 | Warnings | M012 |
| Pressure and Pain Plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | 232acb86-7383-4992-b333-1e47bf7c06ad | 2025-12-11 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | 72847721-9f59-4af1-8f20-dc8449742918 | 2025-12-11 | Warnings | M012 |
| Cold plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | f6401317-0295-14b3-e053-2a95a90acbb4 | 2025-12-11 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | f6401b58-8cf8-4067-e053-2995a90a68fc | 2025-12-11 | Warnings | M012 |
| Sinus Relief Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | b1ba37b8-4558-0808-e053-2995a90a9f5e | 2025-12-11 | 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 |