COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct
- Product NDC
- 76162-678
- 11-digit product format
- 761620678
- Labeler code
- 76162
- Product ID
- 76162-678_f108e17b-8973-49d8-9d1d-5781170f9b4b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Doxylamine Succinate, Phenylephrine Hydrochloride
- Dosage form
- KIT
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-12-11
- 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
- COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-678-24 | COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct | 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 |
|---|---|---|---|---|---|---|
| THERAFLU POWERPODS NIGHTTIME SEVERE COLD | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 39f9feef-4bf2-4f10-9fff-22bbb1d8a471 | 2024-01-30 | Warnings | M012 |
| Theraflu Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | c0689223-5c90-4dbc-bbfa-f94e267504c3 | 2024-01-28 | Warnings | M012 |
| THERAFLU MULTI-SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | a4c56ca0-7785-404b-996d-137cc135f270 | 2024-01-28 | Warnings | M012 |
| THERAFLU NIGHTTIME SEVERE COLD AND COUGH | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 5f7f6f70-0f36-4541-89f2-d953259cdb1e | 2024-01-28 | Warnings | M012 |
| RESFRIOL D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | 0e9c96b9-41ac-0faf-e063-6294a90a8ab5 | 2024-01-26 | Warnings | M012 |
| Allergy Relief | ALLERGY RELIEF | Good Sense | bb709377-7bb3-4931-a2b6-2443aee07c12 | 2024-01-26 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 721bfee2-0d3d-4d8b-beee-1ea83064d1c8 | 2024-01-23 | Warnings | M012 |
| Sugar Free Cough Drops Honey Lemon | MENTHOL | Cardinal Health 110, Inc. | fe90dc33-2815-8296-e053-6294a90ac1df | 2024-01-19 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Cardinal Health 110, Inc. | fe91543e-a798-6399-e053-6394a90af5e5 | 2024-01-19 | Warnings | M012 |
| Sugar Free Cough Drops Black Cherry | MENTHOL | Cardinal Health 110, Inc. | fe90cf63-d286-fa5e-e053-6394a90a7759 | 2024-01-19 | Warnings | M012 |
| Cough Drops Menthol Honey Lemon | COUGH DROPS MENTHOL | Cardinal Health 110, Inc. | fe5b3f6d-2a2d-f322-e053-6394a90aba04 | 2024-01-19 | Warnings | M012 |
| Cough Drops Menthol | MENTHOL COUGH DROPS | Cardinal Health 110, Inc. | fe5b557e-a689-a32c-e053-6294a90aadbd | 2024-01-19 | Warnings | M012 |
| Cough Drops Cherry | CHERRY FLAVOR COUGH DROPS | Cardinal Health 110, Inc. | fe5b5e57-1368-c62b-e053-6294a90ae82c | 2024-01-19 | Warnings | M012 |
| Leader Zinc Oxide | ZINC OXIDE | Cardinal Health 110,Inc. | 4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1 | 2024-01-18 | Warnings | M012 |
| Cough and Congestion DM Sugar Free | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 4656e60e-4733-45c1-bf55-d156e45085c6 | 2024-01-17 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | Rugby Laboratories | 775f97c0-6f82-49a8-82ac-f1a73920c3ec | 2024-01-11 | Warnings | M012 |
| SinuFrin NeilMed | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae | 2024-01-11 | Warnings | M012 |
| SinuFrin Plus NeilMed | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals, Inc. | 99afe6a6-1350-49c6-9347-b7e531e35925 | 2024-01-11 | Warnings | M012 |
| Childrens Tukol Multi-Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | 85fe6f0f-41c8-44d3-a34a-355938da5f72 | 2024-01-11 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 110, LLC. DBA Leader | ad437177-08eb-4811-883f-ac543d5bc58c | 2024-01-11 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634364 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack | GPCK | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 2634364 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | PSN | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 2634364 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | SY | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76162-678-24 | 76162067824 | 1 KIT in 1 CARTON (76162-678-24) * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 kit | 2025-12-11 | No | No | Current |