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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 445e49a2-6ed0-434c-aaea-3ce14bc7df59 | 2024-08-12 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | d49b42ad-0ae0-48c9-adba-5fc2ced97764 | 2024-08-12 | Warnings | M012 |
| RYMED | DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE | EDWARDS PHARMACEUTICALS, INC. | c1d6e914-74cc-4cdf-9587-7eaaa4a386e5 | 2024-08-12 | Warnings | M012 |
| WesTussin DM NF | WESTUSSIN DM NF | Westminster Pharmaceuticals, LLC | 4e0f9f97-a31c-41ac-9d6c-d81efd20fcef | 2024-08-08 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 2f2a2864-af11-4240-bdad-a54aca58d01b | 2024-08-07 | Warnings | M012 |
| Cold plus Flu Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 0199aea2-a9c1-4c9d-8786-28b9dadc832e | 2024-08-07 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 32d1ce6e-2617-4b50-a9e6-2e1941465dff | 2024-08-07 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 07362db5-a372-4463-af8b-06e8783ca865 | 2024-08-07 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1fb11d90-48bf-4baa-9b3a-5d64d81e3a06 | 2024-08-07 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 574774b2-9813-4799-9cd4-27e296dd8584 | 2024-08-07 | Warnings | M012 |
| Cold Max Day and NIght | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | a92bcefb-ba29-4b3f-a60b-b4476ca8cf04 | 2024-08-07 | Warnings | M012 |
| Sinus plus Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 778f1f5a-fd04-456f-90d0-998b93e774a5 | 2024-08-07 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 990f3232-bc75-45cf-8a50-cd7861d83f98 | 2024-08-07 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 0f5f25c6-7389-4285-b8d5-463cb7b6fcc4 | 2024-08-07 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | Care One (Retail Business Services, LLC.) | a9a5b39d-b4c8-414e-8fe7-4c0601f75197 | 2024-08-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | American Health Packaging | b94feeb6-f33f-410d-a9b0-776b1ccf34a9 | 2024-08-04 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | American Health Packaging | 4cd8aee3-5522-434b-a1b1-9591bed3e9a6 | 2024-08-04 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN | American Health Packaging | 8632a655-7f5b-450f-95fa-62478a174e9c | 2024-08-04 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN | American Health Packaging | 990906b3-c566-4f35-923c-060202ba48e0 | 2024-08-04 | Warnings | M012 |
| Honey Lemon Flavor Cough Drops | HONEY LEMON FLAVOR MENTHOL | WHOLE FOODS MARKET, INC. | 1eb7abdc-061f-0e18-e063-6294a90a3a65 | 2024-08-02 | 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 |