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 |
|---|---|---|---|---|---|---|
| Vicks childrens Cough Congestion | PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | The Procter & Gamble Manufacturing Company | e2356457-9791-3710-e053-2995a90ad140 | 2026-09-08 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 077fac1a-0ec5-40d9-8861-a281b48f650a | 2026-09-08 | Warnings | M012 |
| Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | RARITAN PHARMACEUTICALS | eef00453-9f4f-4a05-bb4e-49b94705b52c | 2026-09-08 | Warnings | M012 |
| Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | RARITAN PHARMACEUTICALS INC | 9819155b-2713-42be-867e-16605e7643d0 | 2026-09-08 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | WALMART INC. | f9d1dfd1-527f-491d-9188-14886ac70ced | 2026-09-08 | Warnings | M012 |
| severe cold and cough daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | RARITAN PHARMACEUTICALS INC | 3ce8508e-7d9d-4413-858a-8f952e760c01 | 2026-09-08 | Warnings | M012 |
| Multi Symptom Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | RARITAN PHARMACEUTICALS INC | d9606c9a-31b1-4121-9870-809a05f5b68a | 2026-09-08 | Warnings | M012 |
| Mucus Relief DM Honey and Berry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | RARITAN PHARMACEUTICALS INC | 4898b1c2-55ef-4589-982b-2279c01707e5 | 2026-09-08 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association, Inc. | 2a7afe03-3c34-4e30-827e-b3bb2568cb97 | 2026-09-08 | Warnings | M012 |
| Drx Choice childrens allergy chews | DIPHENHYDRAMINE HCL | RARITAN PHARMACEUTICALS INC | dd2be906-bd0a-437c-9693-54b9391a5da3 | 2026-09-05 | Warnings | M012 |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 49235f4f-e661-4a83-88ef-b9a956848777 | 2026-09-04 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | 71845bf9-8981-4ca0-a62c-dbef102b1b02 | 2026-09-04 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 774d2bde-9f57-4ced-800a-cada39c685ed | 2026-09-04 | Warnings | M012 |
| Nostrilla | OXYMETAZOLINE HYDROCHLORIDE | Insight Pharmaceuticals LLC | 86217847-8e2b-48cc-b289-4987fd3aa7c3 | 2026-09-04 | Warnings | M012 |
| tussin cough chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rite Aid Corporation | 86fc3723-5fc5-4de5-bd04-7774c2abe539 | 2026-09-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Topco Associates, LLC | ed576bf1-3949-423e-af2e-e4b1a3839b21 | 2026-09-04 | Warnings | M012 |
| tussin nighttime cough | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 80d51af8-3a7b-4d22-8d4f-df5f91913047 | 2026-09-04 | Warnings | M012 |
| NO MORE NOSEBLEED | OXYMETAZOLINE HYDROCHLORIDE | DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. | 69d3f1fe-b476-4f84-8c5e-94957b74b46c | 2026-09-04 | Warnings | M012 |
| Ultra Fine Mist Sinus Relief | OXYMETAZOLINE HYDROCHLORIDE | DOLGENCORP, INC. | 5f134840-2465-4585-a85d-08d746f76f7a | 2026-09-03 | Warnings | M012 |
| Daytime Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATE | Family Dollar (FAMILY WELLNESS) | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 2026-09-03 | 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 |