TOPCARE
- Product NDC
- 76162-792
- 11-digit product format
- 761620792
- Labeler code
- 76162
- Product ID
- 76162-792_434f84ba-ba81-a4e6-e063-6394a90ae042
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Topco Associates, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-12
- Substance
- CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
- Active strength
- 1; 5; 160 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- TOPCARE
- Brand name suffix
- Childrens Cold and Cough and Runny Nose
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORPHENIRAMINE MALEATE | 1 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V1Q0O9OJ9Z | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1086750 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8931d4ca-c599-49be-87e1-8c0598f38b77 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-792-04 | TOPCAREChildrens Cold and Cough and Runny Nose | 120 mL in 1 BOTTLE | SUSPENSION | 120 | 2 | |
| 76162-792-04 | TOPCAREChildrens Cold and Cough and Runny Nose | 1 in 1 CARTON | SUSPENSION | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76162-792 | TOPCARE CHILDRENS COLD AND COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [TOPCO ASSOCIATES, LLC] | 1 | Current NDC, 2 package rows | 20240901_8931d4ca-c599-49be-87e1-8c0598f38b77.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 |
|---|---|---|---|---|---|---|
| nasal decongestant maximum strength non drowsy | PSEUDOEPHEDRINE HCL | Meijer Distribution Inc | 8a68ca99-fd76-409a-9769-88830e8720a8 | 2024-09-28 | Warnings | M012 |
| good neighbor pharmacy tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amerisource Bergen | 58687394-b6d2-4d51-bde0-8f2cfa3fe909 | 2024-09-27 | Warnings | M012 |
| good neighbor pharmacy nasal | OXYMETAZOLINE HYDROCHLORIDE | Amerisource Bergen | faee3aae-e819-4084-a127-3449be353b13 | 2024-09-27 | Warnings | M012 |
| Tesalon Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL | OPMX LLC | 2309620a-ccbc-41e9-e063-6394a90a9520 | 2024-09-26 | Warnings | M012 |
| adult cough and chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Meijer, Inc. | b11c4cee-bbb5-4585-9d38-6787553e13a0 | 2024-09-26 | Warnings | M012 |
| COLD AND FLU NIGHTTIME SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9c34e-a0ca-cdf9-e053-2a95a90a93d3 | 2024-09-25 | Warnings | M012 |
| Basic Care Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | 8f3317f6-4ae8-474b-93c3-25e256519cb8 | 2024-09-25 | Warnings | M012 |
| berkley and jensen tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | BJWC | b2de91c9-6af0-4881-8d2d-a69d90c8dfcd | 2024-09-24 | Warnings | M012 |
| Tussin DM Cough and Chest Non Drowsy | DEXTROMETHORPHAN HBR, GUAIFENESIN | WinCo Foods, LLC | 13eb459c-3075-4038-8062-9ee7175b2ab9 | 2024-09-24 | Warnings | M012 |
| equaline nasal decongestant non drowsy maximum strength | PSEUDOEPHEDRINE HCL | United Natural Foods, Inc. dba UNFI | 8897580a-709a-4643-8264-ad003d90cbff | 2024-09-22 | Warnings | M012 |
| Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Dabur India Limited | 22916978-303d-e62a-e063-6394a90a2100 | 2024-09-20 | Warnings | M012 |
| Topcare Nasal Decongestant Maximum Strength Non Drowsy | PSEUDOEPHEDRINE HCL | Topco Associates LLC | 1a9e0336-c0c2-43f8-aeea-668d4a209714 | 2024-09-20 | Warnings | M012 |
| Leader Nasal Decongestant | PSEUDOEPHEDRINE HCL | Cardinal Health 110, LLC. dba Leader | 25609b66-047c-46e7-bc95-20eb8e6c9617 | 2024-09-20 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | CVS Pharmacy | bebe5e78-09ba-4d35-9d34-9f5e34341478 | 2024-09-20 | Warnings | M012 |
| equaline nasal | PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 67fdd277-7a7a-4404-8ca2-39802c46405f | 2024-09-20 | Warnings | M012 |
| equaline tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | 8bc7fa7c-d565-48c9-9808-1042c3e9d428 | 2024-09-20 | Warnings | M012 |
| Leader Adult Tussin Mucus and Chest Congestion 541 | GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | d7fae410-9c1c-4231-9fde-2c51ad3d7e95 | 2024-09-20 | Warnings | M012 |
| sinus | PSEUDOEPHEDRINE HYDROCHLORIDE | Kroger Company | 18812f2a-9b66-45a7-9631-123da6fd1c1f | 2024-09-20 | Warnings | M012 |
| Good Sense Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 930469c1-384c-4440-b3e6-9dcd674871c4 | 2024-09-19 | Warnings | M012 |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 2024-09-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1086750 | acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension | PSN | 8931d4ca-c599-49be-87e1-8c0598f38b77 | 2 |
| 1086750 | acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension | SCD | 8931d4ca-c599-49be-87e1-8c0598f38b77 | 2 |
| 1086750 | acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension | SY | 8931d4ca-c599-49be-87e1-8c0598f38b77 | 2 |
| 1086750 | APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension | SY | 8931d4ca-c599-49be-87e1-8c0598f38b77 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76162-792-04 | 76162079204 | 1 BOTTLE in 1 CARTON (76162-792-04) / 120 mL in 1 BOTTLE | 1 bottle | 2024-08-12 | No | No | Current |