LEADER
- Product NDC
- 70000-0764
- 11-digit product format
- 700000764
- Labeler code
- 70000
- Product ID
- 70000-0764_2212cf9e-6944-4922-b5b5-1373cf10b2e1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- CARDINAL HEALTH 110, LLC. DBA LEADER
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-07-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 1000; 30 mg/1; 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
- LEADER
- Brand name suffix
- Multi Symptom Flu Relief Daytime Max Strength
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 1000 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2636656 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2212cf9e-6944-4922-b5b5-1373cf10b2e1 | 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 |
|---|---|---|---|---|---|---|
| Premier Value | COUGH DROPS CHERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2de803-900d-02f4-e063-6394a90a84cc | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS HONEY LEMON SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2307f3a7-f6e7-8a5d-e063-6394a90ab7eb | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2e8fbe-c1c3-79b1-e063-6394a90a4d73 | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS HONEY LEMON | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2dfcc3-e599-3102-e063-6394a90ad54a | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2ead3c-b4d5-ee8f-e063-6294a90a3c39 | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f42644-045b-c4b3-e063-6294a90a48fd | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS VANILLA HONEY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f45499-bf14-03e4-e063-6394a90a535c | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f3ddcc-9d4e-f1b1-e063-6294a90ac86f | 2025-12-29 | Warnings | M012 |
| Menthol Flavor Cough Drop | MENTHOL FLAVOR COUGH DROP | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a5551-4989-d8fe-e063-6394a90aeabf | 2025-12-29 | Warnings | M012 |
| MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f2acaa-2cc8-a999-e063-6294a90a15ce | 2025-12-29 | Warnings | M012 |
| Leader Throat Soothing Drops Creamy Strawberry | THROAT SOOTHING CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26a92ecc-6a9c-b569-e063-6394a90a8bcb | 2025-12-29 | Warnings | M012 |
| ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | a5ceab90-6885-4f3a-b001-97679e03c01b | 2025-12-29 | Warnings | M012 |
| Goodmeds Non-Drowsy Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | 32482083-3f51-41f4-8d20-bedf143e066d | 2025-12-29 | Warnings | M012 |
| Tusnel EX | GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | 77c16288-68c4-476c-995f-86f505663270 | 2025-12-29 | Warnings | M012 |
| Tusnel DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Llorens Pharmaceutical International Division, Inc. | fe457e6d-422d-496c-bcb9-33594f3c42ff | 2025-12-29 | Warnings | M012 |
| Tusnel Diabetic | DEXTROMETHORPHAN, GUAIFENESIN | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 66b3c094-809e-4d2c-bc15-46563de685cb | 2025-12-29 | Warnings | M012 |
| Fortify | MENTHOL | Natures Formulae Health Products Ltd. | 781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd | 2025-12-29 | Warnings | M012 |
| Safetussin PM Nighttime Cough relief | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Kramer Laboratories | 33dd2245-9abd-4b32-ac76-0f45a54c0f33 | 2025-12-29 | Warnings | M012 |
| Winco Foods Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | WinCo Foods, LLC | f54eb60d-c602-1272-e053-2995a90aa95a | 2025-12-28 | Warnings | M012 |
| Gencare-Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | ad4d74a8-a762-4378-9016-f7c83421073e | 2025-12-26 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70000-0764-1 | 70000076401 | 6 PACKET in 1 CARTON (70000-0764-1) / 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2026-07-01 | No | No | Current |