topcare nite time cold and flu
- Product NDC
- 36800-143
- 11-digit product format
- 368000143
- Labeler code
- 36800
- Product ID
- 36800-143_77dfcc34-4ae3-4910-b469-19d84ddd71c4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-02-02
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 15; 6.25 mg/1; mg/1; mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 36800-143 | 36800-143-73 | D | Discontinued by firm | 2026-10-27 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 36800-143 | 36800-143-73 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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 cold and flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1094549 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 516ab016-31f9-4829-8b94-2f968933093c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-143-62 | topcare nite time cold and flu | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 8 | |
| 36800-143-62 | topcare nite time cold and flu | 12 in 1 CARTON | CAPSULE, LIQUID FILLED | 12 | 8 | |
| 36800-143-73 | topcare nite time cold and flu | 8 in 1 CARTON | CAPSULE, LIQUID FILLED | 8 | 8 | |
| 36800-143-73 | topcare nite time cold and flu | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 8 | |
| 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 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-143 | TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC] | 7 | Current NDC, Legacy NDC, 4 package rows | 20241017_516ab016-31f9-4829-8b94-2f968933093c.zip |
| 36800-143 | TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] | 7 | Current NDC, Legacy NDC | 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 |
|---|---|---|---|---|---|---|
| MGC Health Cough Drops Honey Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3fa17272-fd7f-9ab4-e063-6394a90a585f | 2025-09-25 | Warnings | M012 |
| MGC Health Throat Soothing Drops Creamy Strawberry | PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3fa2e438-2ff3-a2df-e063-6394a90ac7b5 | 2025-09-25 | Warnings | M012 |
| QUALITY CHOICE ADULT TUSSIN EXPECTORANT | GUAIFENESIN | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 63dad603-fe2f-42a6-a626-5c8048a42c10 | 2025-09-25 | Warnings | M012 |
| Giltuss Childrens Allergy Plus | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3fa5220f-38bb-9ef6-e063-6294a90aeff8 | 2025-09-25 | Warnings | M012 |
| Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Health Pharma USA LLC | a03befb4-d86d-43e4-8097-eda5c8bb25be | 2025-09-24 | Warnings | M012 |
| Childrens Giltuss EX Expectorant | GUAIFENESIN | Dextrum Laboratories Inc. | 3f8d7d47-f14c-888c-e063-6394a90a5cdd | 2025-09-24 | Warnings | M012 |
| Childrens Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dextrum Laboratories, Inc | 3f909bc2-eb84-a19d-e063-6294a90ae04e | 2025-09-24 | Warnings | M012 |
| Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Dextrum Laboratories, Inc | 3f79137f-f0b0-d22c-e063-6394a90a7245 | 2025-09-23 | Warnings | M012 |
| GoodSense Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | GOOD SENSE | 240bb6af-9d38-49fe-9011-3016246b0986 | 2025-09-23 | Warnings | M012 |
| Xpect Honey Lemon Cough Drops | HONEY LEMON COUGH DROPS | Cintas Corporation | 79e0b7c1-4acc-41d2-89cd-d075a8bac0c9 | 2025-09-23 | Warnings | M012 |
| Topcare NiteTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | b2b3c450-e988-41d1-9e53-cc8e30d75cb4 | 2025-09-23 | Warnings | M012 |
| Xpect Cherry Cough Drops | CHERRY COUGH DROPS | Cintas Corporation | d1fd2f23-5435-405d-a7fd-644691f79e80 | 2025-09-23 | Warnings | M012 |
| Topcare DayTime NiteTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2025-09-23 | Warnings | M012 |
| Giltuss EX Expectorant | GUAIFENESIN | Dextrum Laboratories Inc. | 3f67ac3d-1503-3418-e063-6394a90a938f | 2025-09-22 | Warnings | M012 |
| Giltuss HBP Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories Inc. | 3f68e68a-cf32-9df8-e063-6394a90a3012 | 2025-09-22 | Warnings | M012 |
| SUPRESS A | DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kramer Novis | f0bec5f5-4d76-471e-9024-557eba848b93 | 2025-09-22 | Warnings | M012 |
| RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 9f050fb0-6100-4b14-b82f-1d5fcbf16540 | 2025-09-22 | Warnings | M012 |
| RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | c6392ace-c7d1-4450-8b71-4dccc60b4f02 | 2025-09-22 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f12ee8f-d1c6-d73a-e063-6394a90a9199 | 2025-09-18 | Warnings | M012 |
| Giltuss D | GILTUSS D | Dextrum Laboratories Inc. | 3f17eefb-b625-b0f2-e063-6294a90afd4d | 2025-09-18 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 516ab016-31f9-4829-8b94-2f968933093c | 8 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 516ab016-31f9-4829-8b94-2f968933093c | 8 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 516ab016-31f9-4829-8b94-2f968933093c | 8 |
| 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 |
|---|---|---|---|---|---|---|---|---|
| 36800-143-62 | 36800014362 | 12 BLISTER PACK in 1 CARTON (36800-143-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 12 blister pack | 2014-02-02 | 0000-00-00 | No | No | Current |
| 36800-143-73 | 36800014373 | 8 BLISTER PACK in 1 CARTON (36800-143-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 8 blister pack | 2014-02-14 | 0000-00-00 | No | No | Current |