Topcare Day Time Nite Time Cold and Flu
- Product NDC
- 36800-597
- 11-digit product format
- 368000597
- Labeler code
- 36800
- Product ID
- 36800-597_d044689b-9b88-4252-8a33-08822cf3ccd3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan HBr, doxylamine succinate, guaifenesin, phenylephrine HCl
- Dosage form
- KIT
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-06-28
- 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
- Topcare Day Time Nite Time Cold and Flu
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| aed387e0-5a8b-4caf-a373-3e04496a4983 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 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 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-597-02 | Topcare Day Time Nite Time Cold and Flu | 1 in 1 CARTON | KIT | 1 | 8 | |
| 36800-603-40 | Topcare Day Time Nite Time Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 10 mg in 15mL | 8 |
| 36800-763-40 | Topcare Day Time Nite Time Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 10 mg in 30mL | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-597 | TOPCARE DAY TIME NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20241116_aed387e0-5a8b-4caf-a373-3e04496a4983.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 |
|---|---|---|---|---|---|---|
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Hy-Vee, Inc. | 446de381-6685-748d-e063-6394a90a1b73 | 2026-02-04 | Warnings, Adverse reactions | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 85aadc86-d979-41a1-849a-e2ccc9014429 | 2026-02-04 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | fa8c154c-56c6-47de-8e43-9e012b4be95f | 2026-02-04 | Warnings | M012 |
| Foster and Thrive Cherry Cough Drops | MENTHOL | McKesson | 49eefa70-cef9-d7ec-e063-6294a90ac321 | 2026-02-03 | Warnings | M012 |
| Foster and Thrive Honey Lemon Cough Drops | MENTHOL | McKesson | 49f13ee3-6bb3-e500-e063-6394a90a152d | 2026-02-03 | Warnings | M012 |
| Daytime Cold and Flu Mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 63cb19d4-2306-4723-a95e-9d2d8b9eccd0 | 2026-02-03 | Warnings | M012 |
| Foster and Thrive SF Honey Lemon Cough Drops | MENTHOL | McKesson | 49f41c30-f806-44ba-e063-6394a90a5a67 | 2026-02-03 | Warnings | M012 |
| Nighttime Cold and Flu Mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | b9af8ab4-a7cb-4adf-9f6f-398c6bb7f853 | 2026-02-03 | Warnings | M012 |
| allergy relief | DIPHENHYDRAMINE HCL | Meijer Distribution Inc | 7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f | 2026-02-03 | Warnings | M012 |
| Cold and Allergy D | PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL | Walgreen Company | 832ac849-7f4a-489a-a704-9d4388a75a71 | 2026-02-03 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 987f908b-7af7-4705-bfb4-c48d771c380d | 2026-02-03 | Warnings | M012 |
| tussin dm nighttime max | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | HyVee Inc | 1f3fb451-84c9-432e-ac67-2694dd66c815 | 2026-02-03 | Warnings | M012 |
| Robafen DM Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Major Pharmaceuticals | 7c9660b7-cb00-449b-b65f-aa42d8ce1942 | 2026-02-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 6b0d261f-fc27-4b34-88b1-cd3d72766760 | 2026-02-02 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | ebfcb699-3369-4697-9841-44015b1c9808 | 2026-02-02 | Warnings | M012 |
| Cherry Sore Throat Lozenges | BENZOCAINE, MENTHOL | Meijer Distribution Inc. | 2f6de590-7cad-25d7-e054-00144ff8d46c | 2026-02-02 | Warnings | M012 |
| Mixed Berry Sore Throat and Cough lozenge | DEXTROMETHORPHAN HYDROBROMIDE | Meijer Distribution, Inc. | 304ff4db-201a-60a4-e054-00144ff8d46c | 2026-02-02 | Warnings | M012 |
| Allergy Relief Plus Congestion | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreen Company | 38d91107-d95c-40f2-a27e-561f951e519d | 2026-02-02 | Warnings | M012 |
| Tussin Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | HyVee Inc | 85252999-3463-45fe-b4a9-7a97960b41b1 | 2026-02-02 | Warnings | M012 |
| Amazon Basics Cherry Cough Drops 30ct | MENTHOL | Amazon | 3e74e209-c9c9-3979-e063-6294a90afcfa | 2026-02-01 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637731 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-597-02 | 36800059702 | 1 KIT in 1 CARTON (36800-597-02) * 355 mL in 1 BOTTLE (36800-763-40) * 355 mL in 1 BOTTLE (36800-603-40) | 1 kit | 2014-06-28 | 0000-00-00 | No | No | Current |
| 36800-603-40 | 36800060340 | 355 mL in 1 BOTTLE | 355 ml | Historical | ||||
| 36800-763-40 | 36800076340 | 355 mL in 1 BOTTLE | 355 ml | Historical |