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 |
|---|---|---|---|---|---|---|
| Mucinex Fast-Max Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 3270f369-7a40-186d-e063-6394a90a8526 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | fe44d1ee-1e03-b74f-e053-6294a90a8bb4 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 31ac6883-ffcd-39de-e063-6294a90a52dd | 2026-05-19 | Warnings | M012 |
| MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 325b41e1-f8d2-02ee-e063-6394a90aafff | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 326f1fd3-73ab-e515-e063-6294a90ab222 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 6c85df30-a601-4de6-9fd6-818265d799ff | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 7050b583-c09b-4457-9a9c-70c0923b62c0 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27312ee4-d1f4-4a95-9c45-91fa5a01f5ba | 2026-05-19 | Warnings | M012 |
| Mucinex Rapid Clear Daytime Pain, Headache, and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 37de53a7-5546-3804-e063-6294a90a0fb5 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 36b07e49-c72c-45e5-e063-6394a90a804a | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus Max Clear and Cool Severe Congestion | OXYMETAZOLINE HCI | Reckitt Benckiser LLC | 2ee95e17-bd94-d717-e063-6294a90a2173 | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus Max Sinus Pressure Severe Congestion | OXYMETAZOLINE HCI | Reckitt Benckiser LLC | 2eeafd83-230c-af92-e063-6294a90a984e | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Congestion and Headache Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7017328-f8af-4601-9232-dc1104feaa0a | 2026-05-19 | Warnings | M012 |
| Mucinex Rapid Clear Pain Headache and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 32375b12-75ed-d605-e063-6294a90ad004 | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 07da45b5-d05e-41b1-b233-f7034d556a8d | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | ad4e0e4d-cc1f-4176-835f-3ba76564c634 | 2026-05-19 | Warnings | M012 |
| Childrens Mucinex Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 60daf6e2-ded8-44e6-bd8d-9d221384adde | 2026-05-19 | Warnings | M012 |
| Mucinex Childrens Mini Melts Cold and Flu | ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 401fe0a0-ec97-5248-e063-6394a90af27f | 2026-05-19 | Warnings | M012 |
| Childrens Cough and Congestion, Childrens Cold and Cough Day, Night | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | WALMART INC. | 312ae879-1124-40a4-b2ba-3f3070840021 | 2026-05-19 | Warnings | M012 |
| GOOD SENSE DAYTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | L. Perrigo Company | 2597e84c-18b4-41a9-8e6a-ff0c4c1f0612 | 2026-05-18 | 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 |