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 |
|---|---|---|---|---|---|---|
| Cold and Sinus Maxium Strength | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | 6e5ca8e1-5a03-4e77-b385-d44387fb3bfc | 2023-12-29 | Warnings | M012 |
| Cold, Flu and Sore Throat Maxium Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | d98029c0-ccd9-47e1-996f-c7786cd4ecca | 2023-12-29 | Warnings | M012 |
| MAXIMUM STRENGTH Sinus Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 0f2be061-bd0a-4e62-b994-6d0768ea647a | 2023-12-29 | Warnings | M012 |
| Tussin CF Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | c19b9997-4037-48f3-b905-86da421a292d | 2023-12-29 | Warnings | M012 |
| HempNesic | MENTHOL, CAMPHOR | Blaine Labs Inc. | 0239ada0-644d-4ef4-a3b8-df70246a3bc2 | 2023-12-21 | Warnings | M012 |
| HempNesic | MENTHOL, CAMPHOR | Blaine Labs Inc. | a698502d-c1c5-41ca-8142-74338b834c8b | 2023-12-21 | Warnings | M012 |
| Father Johns Cough Medicine Plus | NASAL DECONGESTANT | Oakhurst Company | 8b8aab0f-251b-6bd8-e053-2995a90ad748 | 2023-12-18 | Warnings | M012 |
| Father Johns Medicine | DEXTROMETHORPHAN HBR | Oakhurst Company | 8b8a249d-55af-cc98-e053-2995a90a431d | 2023-12-18 | Warnings | M012 |
| Daytime Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATED | Lil' Drug Store Products, Inc. | e79d92d2-d73c-d44f-e053-2995a90a03d9 | 2023-12-15 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL TABLET | Lil' Drug Store Products, Inc. | e5339c39-1d66-b283-e053-2995a90a4317 | 2023-12-15 | Warnings | M012 |
| Father Johns Medicine | DEXTROMETHORPHAN HBR | Humco Holding Group, Inc | a7b0669f-8da1-5a44-e053-2995a90a84d9 | 2023-12-15 | Warnings | M012 |
| Ephedrine Hydrochloride | EPHEDRINE HYDROCHLORIDE | Walgreen Company | bcb81dc1-d854-30c0-e053-2a95a90a9fc7 | 2023-12-14 | Warnings | M012 |
| Allergy, Circle K | DIPHENHYDRAMINE HCL 25MG TABLET | Lil' Drug Store Products, Inc. | d1f370ac-e7f4-baf7-e053-2995a90a1e50 | 2023-12-14 | Warnings | M012 |
| Circle K Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | a6a1e3d9-575c-4adf-beb6-c9719de55c67 | 2023-12-14 | Warnings | M012 |
| Non-Drowsy Sinus Severe, Circle K | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED | Lil' Drug Store products, Inc. | e78c456f-f62e-596d-e053-2995a90a2397 | 2023-12-14 | Warnings | M012 |
| Non-Drowsy Max Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATED | Lil' Drug Store Products, Inc. | e79f1a92-d8ea-e3f9-e053-2a95a90a2d37 | 2023-12-14 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Major Pharmaceuticals | bcc1a001-4176-485d-aaf0-2037ca65c6b8 | 2023-12-14 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Major Pharmaceuticals | edb49b17-06a7-4c25-bc7c-d62c1deac7f1 | 2023-12-13 | Warnings | M012 |
| Family Wellness Oxymetazoline No Drip | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 0c006b1c-8ab2-4b9c-8738-e7001c1bb47d | 2023-12-11 | Warnings | M012 |
| Daytime Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORP | 0b1e230d-4354-bf61-e063-6394a90a2b2f | 2023-12-09 | 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 |