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 |
|---|---|---|---|---|---|---|
| Walgreens NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | WALGREEN COMPANY | 5bf72e2f-15c8-466a-9e13-50654233da91 | 2026-01-19 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | 9862f84d-1c18-4ef7-86dc-98572599d417 | 2026-01-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 37853689-c9ca-4bc7-9c5b-4a68b8d778be | 2026-01-19 | Warnings | M012 |
| VAPORX | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | AKRON PHARMA INC | 51b32162-0c5a-4b5b-999a-34337d816603 | 2026-01-19 | Warnings | M012 |
| Equate | OXYMETAZOLINE HCL | Walmart Inc | 2f762c24-2442-506a-e063-6394a90a3b96 | 2026-01-19 | Warnings | M012 |
| Dimetane | DIPHENHYDRAMINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 2026-01-19 | Warnings | M012 |
| nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | f681d986-9838-42d8-8ed9-732a39fbf870 | 2026-01-19 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | H E B | 22d241c5-a3fd-4619-8147-91d7a4c8cf98 | 2026-01-19 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | Better Living Brands, LLC | 9fe63ca6-3863-4175-9aec-ecd6ebbdb249 | 2026-01-19 | Warnings | M012 |
| Good Neighbor Pharmacy Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | 5749ce9d-e182-478f-ab88-b520a35a99a7 | 2026-01-19 | Warnings | M012 |
| Foster and Thrive Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Strategic Sourcing Services LLC | 1d9150b1-2f6c-4c33-8c93-3ed1d88585e2 | 2026-01-18 | Warnings | M012 |
| HealthWise Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | ce3ceffd-3ff5-3795-e053-2995a90a827f | 2026-01-18 | Warnings | M012 |
| topcare nite time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Topco Associates LLC | 31210a95-f9dc-49db-aab5-25c4dca49266 | 2026-01-17 | Warnings | M012 |
| Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f77226c0-b6d5-9fd0-e053-6294a90a4b57 | 2026-01-16 | Warnings | M012 |
| Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f691734b-5cf4-6eb8-e053-2a95a90aee80 | 2026-01-16 | Warnings | M012 |
| Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f771aa19-295a-9f4e-e053-6294a90a1674 | 2026-01-16 | Warnings | M012 |
| CVS Cherry Cough Drops | MENTHOL | CVS Pharmacy | de5c4b94-0420-5d43-e053-2995a90aa5a5 | 2026-01-16 | Warnings | M012 |
| CVS Honey Lemon Cough Drops | MENTHOL | CVS Pharmacy | de963dc3-8108-440f-e053-2995a90a906f | 2026-01-16 | Warnings | M012 |
| CVS SF Menthol Cough Drops | MENTHOL | CVS Pharmacy | e08f8ca3-b683-4964-e053-2a95a90afabb | 2026-01-16 | Warnings | M012 |
| CVS SF Honey Lemon Cough Drops | MENTHOL | CVS Pharmacy | e0cdeccf-c32f-318a-e053-2a95a90ac401 | 2026-01-16 | 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 |