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 |
|---|---|---|---|---|---|---|
| Sinus Relief Daytime, Nighttime, Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | f6b3ca40-7638-477f-b800-4c28c40ff0a8 | 2025-12-11 | Warnings | M012 |
| Allergy Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreen Company | 0a6e3251-02e0-42c1-bdf3-51c77f88c17f | 2025-12-11 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Topco Associates LLC | 516ab016-31f9-4829-8b94-2f968933093c | 2025-12-11 | Warnings | M012 |
| Sinus PE Congestion | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreen Company | 5b9151b7-3e40-4f37-b3e0-4c0fa0115b71 | 2025-12-10 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Discount Drug Mart | 2344c048-0550-4c31-b54e-a198910c490e | 2025-12-10 | Warnings | M012 |
| CVS Maximum Strength Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL | CVS PHARMACY, INC | cf4eb4c4-68e0-4478-a81c-d3d1e66f5cc5 | 2025-12-10 | Warnings | M012 |
| Tylenol Cold plus Flu Severe, Lil Drug Store | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Lil Drug Store Products, Inc | f395c196-62d7-47ff-b38d-af37adf5980b | 2025-12-10 | Warnings | M012 |
| Tylenol Sinus Severe, Lil Drug Store | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Lil Drug Store Products, Inc | 88b68447-b016-4d5b-a5e3-c4ebccb14f8c | 2025-12-10 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Family Dollar Services Inc | d956f1b8-91f8-424b-bb6c-704c445b6f4c | 2025-12-10 | Warnings | M012 |
| good neighbor pharmacy day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | e5c1bd96-d27d-49c1-b3b8-eee53a145ef5 | 2025-12-10 | Warnings | M012 |
| NiteTime SEVERE Cold and Flu Relief SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 3ffe67bf-2c66-61e6-e063-6394a90a7f8f | 2025-12-10 | Warnings | M012 |
| DayTime SEVERE Cold and Flu Relief SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 3ffe0f43-b92a-f947-e063-6394a90ab72c | 2025-12-10 | Warnings | M012 |
| MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ct | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | a7285fe0-5a5b-42c4-be47-9a07a2ba75e8 | 2025-12-10 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | f9b8dbe1-7ff9-4320-850c-6e86e98d4393 | 2025-12-09 | Warnings | M012 |
| Severe Nasal | OXYMETAZOLINE HYDROCHLORIDE 0.05% | ALAINA HEALTHCARE PRIVATE LIMITED | 27747a10-8d1d-41c2-80b9-45452f3b9abc | 2025-12-09 | Warnings | M012 |
| Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL AND MENTHOL | ALAINA HEALTHCARE PRIVATE LIMITED | 4c6a7ac0-be76-42b0-9a08-b287e70a3460 | 2025-12-09 | Warnings | M012 |
| 24-7 Life BY 7-ELEVEN Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION | Lil' Drug Store products, Inc. | 277363f4-1c00-ddb7-e063-6294a90a4677 | 2025-12-09 | Warnings | M012 |
| Daytime Cold and Flu Relief, 24-7 Life BY 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 2771d699-3f70-4318-e063-6394a90a89cc | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Shield Pharmaceuticals Corp | 3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b | 2025-12-09 | Warnings | M012 |
| Circle K Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc | 9a32bc6d-0499-48fa-a6ad-702c8a28bf5f | 2025-12-09 | 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 |