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 |
|---|---|---|---|---|---|---|
| Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom Relief | CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE | WAL-MART STORES,INC. | 68a68574-0fcb-4569-be57-d9aee5f62bea | 2025-10-28 | Warnings | M012 |
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 635009a1-6154-4c62-a4be-d4f32c2cef8d | 2025-10-28 | Warnings | M012 |
| Publix Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | cf49a06d-f095-48bf-bcd2-a410066ff9af | 2025-10-28 | Warnings | M012 |
| Publix | OXYMETAZOLINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | 283e42b9-173c-4deb-9377-ff649efc177f | 2025-10-28 | Warnings | M012 |
| Publix Extra Moisturizing | OXYMETAZOLINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | eae83b75-9d5a-4100-9304-629e54ef7752 | 2025-10-28 | Warnings | M012 |
| Publix | PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | f10e120d-f0b7-4c51-b29b-e8cdbb1456f3 | 2025-10-28 | Warnings | M012 |
| Family Care Nasal Relief | OXYMETAZOLINE HYDROCHLORIDE | United Exchange Corp | 6d0f8e9e-0503-522b-e053-2a91aa0aca35 | 2025-10-28 | Warnings | M012 |
| Family Care Nasal Relief | OXYMETAZOLINE HYDROCHLORIDE | United Exchange Corp | 6d0eef2f-f546-d769-e053-2991aa0a8fe4 | 2025-10-28 | Warnings | M012 |
| Tussin DM Cough and Chest Congestion Adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | P & L Development, LLC | 4af67ba7-8892-442c-b9fb-80aba9140e05 | 2025-10-28 | Warnings | M012 |
| No Drip Nasal Mist Nasal Decongestant Severe Congestion | OXYMETAZOLINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 994fa270-65bb-4097-b88a-d5ce3c0e1c79 | 2025-10-27 | Warnings | M012 |
| Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | WAL-MART STORES INC. | 3652ee94-b762-4100-a305-5acbec5f795a | 2025-10-27 | Warnings | M012 |
| 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 |
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 |