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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Childrens Multi-symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores, Inc. | 177e3247-402d-98e4-e063-6294a90ae068 | 2024-11-26 | Warnings | M012 |
| Alka-Seltzer Plus Cold and Flu, CVP | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET | Lil' Drug Store Products, Inc. | e7a27773-69d6-9e07-e053-2a95a90af8ea | 2024-11-25 | Warnings | M012 |
| DayTime Sinus Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 4361912e-4b56-4743-b11d-acfb94482a2e | 2024-11-25 | Warnings | M012 |
| NightTime Sinus Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 413d82d3-a896-4f15-9fca-c1b7b9a1ee63 | 2024-11-25 | Warnings | M012 |
| Night Cold Flu Cough and Allergy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0 | 2024-11-25 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | cbd3a905-1c41-4cb0-8df6-36784430d627 | 2024-11-25 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 7a28d0fe-0e0a-453a-b604-1cc784dd153c | 2024-11-25 | Warnings | M012 |
| Cough and Cold plus | ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | c483d88f-cb0a-4dd6-b3ae-559521782ba6 | 2024-11-25 | Warnings | M012 |
| DayTime Sinus | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | a0b01aef-4248-4d41-862c-0c8884dfca5e | 2024-11-25 | Warnings | M012 |
| DayTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 3af20739-6794-42e0-b404-3f0401d10a6d | 2024-11-25 | Warnings | M012 |
| Dextromethorphan HBr 15 mg | DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. | ffc7e1e2-b664-461b-963d-764bad2f983f | 2024-11-25 | Warnings | M012 |
| 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 |
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 |