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 |
|---|---|---|---|---|---|---|
| Maximum Strength Mucus Relief Cold,Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL | Wal-Mart Stores,Inc., | 2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc | 2025-10-27 | Warnings | M012 |
| Allergies MY CHILD NEEDS HELP WITH | DIPHENHYDRAMINE HCL | Unconditional Love | 5ad293e9-0a4b-4923-8a91-f01450726828 | 2025-10-27 | Warnings | M012 |
| basic care daytime severe cold and flu nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Amazon.com Services LLC | 4a9fd615-b7d3-452c-ac40-d9189124faaa | 2025-10-24 | Warnings | M012 |
| allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer Distribution Inc | 622b12fa-455c-4432-a9a2-698a929bbd68 | 2025-10-24 | Warnings | M012 |
| Dristan 12 hr | OXYMETAZOLINE HYDROCHLORIDE | Foundation Consumer Brands | 522876fe-a412-4ca8-bfad-a313e3cbc1af | 2025-10-24 | Warnings | M012 |
| Dimetapp Multi-Symptom Cold and Flu | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 178fe95b-e1ed-43b2-e063-6294a90a7a78 | 2025-10-24 | Warnings | M012 |
| Menthol Drops Dollar General Severe 45ct | MENTHOL | Dollar General Corporation | c831d3d9-b910-40e6-bfdf-defe6850614d | 2025-10-24 | Warnings | M012 |
| Cough Drops Dollar General Strawberry 30ct | MENTHOL | Dollar General Corporation | 7d2f3292-bb73-41dc-9729-edb83670be1b | 2025-10-24 | Warnings | M012 |
| Freegells Cough Drops Menthol 30ct | MENTHOL | R.L. ALBERT & SON, INC | b174e57c-4e4f-4842-b8f2-f1b067764a68 | 2025-10-24 | Warnings | M012 |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 17640528-c1f7-4881-ba86-bb3f488a952c | 2025-10-24 | Warnings | M012 |
| Vapor Stick | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 33e259d6-b065-a677-e063-6394a90ab314 | 2025-10-23 | Warnings | M012 |
| Severe Nighttime Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 2025-10-23 | Warnings | M012 |
| Rycontuss | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories, Inc | 41afb883-1158-9764-e063-6294a90a1712 | 2025-10-21 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE | CVS Pharmacy, Inc | 1532ee21-e114-ded7-e063-6294a90ab025 | 2025-10-21 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 1538bf63-d020-3ba2-e063-6294a90aecc5 | 2025-10-21 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 389230e5-775e-5b0d-e054-00144ff88e88 | 2025-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Method Pharmaceuticals, LLC | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 2025-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Method Pharmaceuticals, LLC | 312ce620-4841-7488-e054-00144ff88e88 | 2025-10-21 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Method Pharmaceuticals, LLC | 5a60c923-8bb7-427f-9636-08ed5474f71b | 2025-10-21 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 311e2b6b-21cb-4b4c-a78d-a0732d29602f | 2025-10-21 | 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 |