Dextromethorphan HBr
- Product NDC
- 69452-573
- 11-digit product format
- 694520573
- Labeler code
- 69452
- Product ID
- 69452-573_5a5dde7e-05b9-13e7-e063-6394a90a197e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- BIONPHARMA INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-08-31
- 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
- 2027-12-31
- 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
- Listing expiration
- 2027-12-31
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 |
|---|---|
| 5a5dde85-8785-8149-e063-6294a90a4d57 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Mucus Relief Immediate Release | GUAIFENESIN | Allegiant Health | 221d64a2-b8c7-435a-aae4-fb58fd38108f | 2019-03-26 | Warnings | M012 |
| Sleep Tabs For Nighttime use | DIPHENHYDRAMINE HCL TABLETS | Allegiant Health | 566e40b1-e9d7-44e4-b971-eef2b7cf0a7d | 2018-12-26 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Allegiant Health | 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 | 2018-12-26 | Warnings | M012 |
| Sleep Aid | DIPHENHYDRAMINE HCL 25 MG | Allegiant Health | dbbc535f-515a-4d9b-b799-34e60f5230bb | 2018-12-21 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | Allegiant Health | c2823bad-540f-4662-8dcc-58e9f0d94efb | 2018-11-07 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength Non-Drowsy | PHENYLEPHRINE 10 MG | Allegiant Health | 7aef00df-816a-4ea2-a2ad-beed66dd2fe4 | 2018-11-07 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | a58bfb14-28f9-4425-a5a5-aaff4847c979 | 2018-03-14 | Warnings | M012 |
| Chlorpheniramine maleate 4mg | CHLORPHENIRAMINE MALEATE 4MG | Athlete's Needs, Inc. | 4d974959-25fc-4707-9b72-9afbf47b76f1 | 2017-11-14 | Warnings | M012 |
| Cold Medicine | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Selder, S.A. de C.V. | d2762d9c-e7e7-42b2-a26a-14b2aa0307cb | 2017-01-25 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Marc Glassman, Inc. | 2051247f-ce64-4cf5-b449-9ca14c43ab86 | 2016-12-27 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 69452-573-17 | 69452057317 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-573-17) | 2026-08-31 | No | No | Current |