Topcare Nite Time Day Time
- Product NDC
- 36800-580
- 11-digit product format
- 368000580
- Labeler code
- 36800
- Product ID
- 36800-580_58aafd33-e288-483d-82c0-edd3ac369c60
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
- Dosage form
- KIT
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-04-29
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 Nite Time Day Time
- Brand name suffix
- Cold and Flu
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-143-73 | Topcare Nite Time Day TimeCold and Flu | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 16 | 6.25 mg | 7 |
| 36800-143-73 | Topcare Nite Time Day TimeCold and Flu | 8 in 1 CARTON | CAPSULE, LIQUID FILLED | 325 mg | 7 | |
| 36800-580-72 | Topcare Nite Time Day TimeCold and Flu | 1 in 1 CARTON | KIT | 1 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-580 | TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20241116_efb8e0e2-0795-4f4a-8ca6-955f33bee143.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 |
|---|---|---|---|---|---|---|
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Meijer, Inc. | fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a | 2025-07-03 | Warnings | M012 |
| Cabinet Allergy Relief Refill Diphenhydramine HCI | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | d47553a4-ca15-4f0a-8177-d743a5c39cc5 | 2025-07-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Advanced Rx LLC | 20e164b8-4cbc-cf3f-e063-6394a90a9d0c | 2025-07-02 | Warnings | M012 |
| 24/7 Life Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENT | Lil' Drug Store Products, Inc. | f03430d4-8dbb-4fc0-e053-2a95a90a119d | 2025-07-02 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | KJD Pharma Private Limited | b109249a-a0be-41bd-b6ce-ef621b588ddc | 2025-07-02 | Warnings | M012 |
| Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy | 91c803c8-6cf8-4ff6-b376-ea6d65f9f227 | 2025-07-01 | Warnings | M012 |
| WALGREENS Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALGREENS CO. | cc2fdc6b-8319-47c8-b036-37dbd65d5833 | 2025-06-30 | Warnings | M012 |
| WALGREENS Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALGREENS CO. | 91c369b0-8620-4764-a85d-a86402d9489c | 2025-06-30 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl 25mg SoftGel | DIPHENHYDRAMINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | bb9a82b1-ea7a-4d10-bc00-05013e83c4d3 | 2025-06-30 | Warnings | M012 |
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS, LLC | 202f0661-461c-0333-e063-6294a90a96b5 | 2025-06-28 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | CVS Pharmacy | f038b713-0721-2bb5-e053-2a95a90a7842 | 2025-06-26 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl 25mg SoftGel | DIPHENHYDRAMINE HYDROCHLORIDE | NUVICARE LLC | bb728ceb-8eb0-4192-a8b0-742756819a05 | 2025-06-26 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | TIME CAP LABORATORIES, INC | 7aee34b5-1583-4a8a-8ffb-b17ef2722ac1 | 2025-06-25 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREENS | c0270298-e7c5-e500-e053-2995a90aed23 | 2025-06-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walmart Inc. | 24ff91f2-02db-56a2-e063-6394a90a31c9 | 2025-06-25 | Warnings | M012 |
| Cough and Chest Congestion Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | e920b700-30d3-3266-e053-2a95a90a0639 | 2025-06-24 | Warnings | M012 |
| good sense childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | L. Perrigo Company | 2ffe0fbc-236d-417b-bbfd-5b9294f3c90a | 2025-06-23 | Warnings | M012 |
| Exchange Select Cough Drop Black Cherry Sugar Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 38034ad2-5eab-9caf-e063-6294a90abb8f | 2025-06-20 | Warnings | M012 |
| Herbal Cough Drops | HERBAL MENTHOL | Meijer, Inc. | 380364be-4e52-fa52-e063-6394a90a713c | 2025-06-20 | Warnings | M012 |
| DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED | Lil' Drug Store Products, Inc. | 37c55543-e05e-2f7c-e063-6394a90a4534 | 2025-06-20 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 7 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 7 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 7 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 7 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 7 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 7 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 7 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 7 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-143-73 | 36800014373 | 2 in 1 BLISTER PACK | Historical | |||||
| 36800-580-72 | 36800058072 | 1 KIT in 1 CARTON (36800-580-72) * 8 BLISTER PACK in 1 CARTON (36800-143-73) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 kit | 2014-04-29 | 0000-00-00 | No | No | Current |