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 |
|---|---|---|---|---|---|---|
| Walgreen NightTime Cold and Flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREENS CO. | 6b3766e6-d0d4-49e0-90da-fc893aef3329 | 2025-11-25 | Warnings | M012 |
| Adult Allergy Relief Dye Free | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | 586310f3-0014-4cfc-9d86-961b3fb7aa8c | 2025-11-25 | Warnings | M012 |
| childrens Allergy Dye Free Wal Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN CO. | 4e64e040-1662-4dc9-b33f-3e119e0b3f7b | 2025-11-25 | Warnings | M012 |
| Walgreen | NASAL | WALGREENS CO | d38f8406-d7b9-472c-a472-58968bbdb993 | 2025-11-25 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 2025-11-25 | Warnings | M012 |
| Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | d13efbcd-1277-45d0-8389-1ba0337f7a24 | 2025-11-25 | Warnings | M012 |
| Childrens Robitussin Elderberry Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | fe903448-b422-42e0-b05b-aeb3e5481e3c | 2025-11-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP INC | 1d4fcb76-22d1-7292-e063-6394a90af920 | 2025-11-25 | Warnings | M012 |
| ROBITUSSIN LONG-ACTING COUGH Soft CHEWS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | f22248b7-7abd-4df7-a986-dae357ebe8f1 | 2025-11-25 | Warnings | M012 |
| ROBITUSSIN Nighttime Cough DM Soft CHEWS | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 39468746-e06d-4849-9d06-9af4d14351b0 | 2025-11-25 | Warnings | M012 |
| Daytime and Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Grocery Outlet, Inc. | 4478fd51-bae3-6108-e063-6394a90a07ca | 2025-11-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC. | 395bb39a-e26f-f4f2-e063-6394a90ae721 | 2025-11-25 | Warnings | M012 |
| day time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | eaf3af6a-de5b-43fe-83ff-9641646e0f6b | 2025-11-25 | Warnings | M012 |
| MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | RB Health (US) LLC | 38571853-992f-9998-e063-6394a90a8581 | 2025-11-24 | Warnings | M012 |
| Basic Care Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | e19b561c-fb76-4355-a306-d3dc46930bf2 | 2025-11-24 | Warnings | M012 |
| Sinus Decongestion | PSEUDOEPHEDRINE HCL | Kroger Company | 73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c | 2025-11-24 | Warnings | M012 |
| Tussin Multi Symptom Cold CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Cardinal Health (Leader) 70000 | 14c507df-fbac-4a09-a66c-b91c2abbf550 | 2025-11-24 | Warnings | M012 |
| Severe Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI | Family Dollar (FAMILY WELLNESS) | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 2025-11-24 | Warnings | M012 |
| Throat Coat Eucalyptus Mint | MENTHOL | Traditional Medicinals, Inc. | a7a86f1b-30e8-6f5d-e053-2a95a90a2a82 | 2025-11-21 | Warnings | M012 |
| Throat Coat Sweet Orange Fennel | MENTHOL | Traditional Medicinals, Inc. | 4538248f-11cc-d6b2-e063-6294a90a652c | 2025-11-21 | 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 |