TOPCARE
- Product NDC
- 76162-559
- 11-digit product format
- 761620559
- Labeler code
- 76162
- Product ID
- 76162-559_434fa5bc-e527-b21b-e063-6394a90a1a54
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, and Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
- Dosage form
- KIT
- Labeler
- Topco Associates, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-16
- 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
- TOPCARE
- Brand name suffix
- Multi Symptom Flu Relief Combo Pack
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 01c517e5-d693-4926-9eb5-4b894a2f6917 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-539-06 | TOPCAREMulti Symptom Flu Relief Combo Pack | 6 in 1 CARTON | POWDER | 6 | 1000 mg | 2 |
| 76162-549-06 | TOPCAREMulti Symptom Flu Relief Combo Pack | 6 in 1 CARTON | POWDER | 6 | 4 mg | 2 |
| 76162-559-12 | TOPCAREMulti Symptom Flu Relief Combo Pack | 1 in 1 CARTON | KIT | 1 | 2 |
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 |
|---|---|---|---|---|---|---|
| HISTEX-DM New Formulation | DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI | Allegis Pharmaceuticals, LLC | 30010401-e5b4-2bd9-e063-6394a90a0b0b | 2025-03-10 | Warnings | M012 |
| daytime severe cold multi-symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd | 2025-03-08 | Warnings | M012 |
| Cold and Head Congestion Relief Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | WinCo Foods, LLC | a39778ba-1f63-4495-8e9b-44b0bdd7f71a | 2025-03-08 | Warnings | M012 |
| Extra Strength TYLENOL Severe Cough Plus Sore Throat Day | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 2e9540e4-bd1d-9370-e063-6294a90affcb | 2025-03-07 | Warnings | M012 |
| Herbal Cough Drops Original Herb | COUGH DROPS | Topco Associates LLC | 2fb22181-aee3-d0bf-e063-6294a90a7865 | 2025-03-06 | Warnings | M012 |
| REVASOL DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Rnv LLC | 2f9ddcc3-b913-f8b0-e063-6294a90a93ab | 2025-03-05 | Warnings | M012 |
| Herbal Throat Drops Lemon Mint Herb | THROAT DROPS | Topco Associates LLC | 2fa086b4-3b0e-0df8-e063-6294a90a6769 | 2025-03-05 | Warnings | M012 |
| Redicare Nasal and Sinus Decongestant | REDICARE NASAL AND SINUS DECONGESTANT | Redicare LLC | 2f24be68-f30e-d916-e063-6294a90a7e31 | 2025-03-04 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HCL ORAL SOLUTION | Kesin Pharma Corporation | 2f871005-de4d-8b2a-e063-6394a90aa43a | 2025-03-04 | Warnings | M012 |
| CVS Daytime Cough Relief Chews - Citrus Punch | DEXTROMETHORPHAN HBR | CVS | 2f885f1b-7ff5-251b-e063-6394a90a656f | 2025-03-04 | Warnings | M012 |
| CVS Dex-Dox Kids Nighttime Cough Suppressant | DEXTROMETHORPHAN HBR | CVS | 2f8b6f5e-399c-b033-e063-6294a90ac3d1 | 2025-03-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | ff8b096c-8f01-4a8c-a98f-e4aa4d688e95 | 2025-03-04 | Warnings | M012 |
| Menthol Cough Drops Honey Vanilla Flavor | MENTHOL | 7-ELEVEN | 2f3c43dd-175f-722e-e063-6294a90acff9 | 2025-02-28 | Warnings | M012 |
| Menthol Cough Drops Creamy Strawberry Flavor | MENTHOL AND PECTIN | 7-ELEVEN | 2f3c3c65-4178-6304-e063-6294a90a51fa | 2025-02-28 | Warnings | M012 |
| Menthol Cough Drops Creamy Strawberry Flavor | MENTHOL AND PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2efbffd7-bbdd-c5f5-e063-6294a90a15f0 | 2025-02-25 | Warnings | M012 |
| Menthol Cough Drops Honey Vanilla Flavor | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2efc46c9-a421-1998-e063-6394a90aeb64 | 2025-02-25 | Warnings | M012 |
| Redicare Cough Drops Cherry Flavored | CHERRY FLAVORED MENTHOL COUGH DROPS | Redicare LLC | 2efeaafa-ee96-37ee-e063-6394a90a9a4b | 2025-02-25 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | Genexa Inc. | e880b8d7-61c3-41cc-e053-2995a90aaaeb | 2025-02-20 | Warnings | M012 |
| Gencare-Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | 596ec923-56a0-4b6e-a69c-8d740feb75a2 | 2025-02-20 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 77a2dc96-73ee-4ca2-b1fe-406995802606 | 2025-02-19 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2636659 | {1 (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } Pack | GPCK | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
| 2636659 | {1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } Pack | PSN | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral Solution | PSN | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
| 2636656 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | PSN | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SCD | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
| 2636656 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SCD | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
| 2636659 | {1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) } Pack | SY | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution | SY | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
| 2636656 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution | SY | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
| 2636658 | APAP 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SY | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
| 2636656 | APAP 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SY | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76162-539-06 | 76162053906 | 6 in 1 CARTON | Historical | ||||
| 76162-549-06 | 76162054906 | 6 in 1 CARTON | Historical | ||||
| 76162-559-12 | 76162055912 | 1 KIT in 1 CARTON (76162-559-12) * 6 POWDER in 1 CARTON (76162-539-06) * 6 POWDER in 1 CARTON (76162-549-06) | 1 kit | 2025-05-16 | No | No | Current |