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 | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| CareOne Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | American Sales Company | c9342ad2-84dc-4f4c-9b05-c6e5c1c7989e | 2026-08-04 | Warnings | M012 |
| dg health cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 3d8ce88e-9f40-4b58-a811-160ddbfb8112 | 2026-08-04 | Warnings | M012 |
| ValuRx Dye Free Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Shield Pharmaceuticals Corp | ca60a413-b02e-48ce-985d-4d415780c679 | 2026-08-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Rite Aid Corporation | 20af2586-f8ac-47a3-9f8d-de255f919328 | 2026-08-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 150b68ba-3ed4-4533-9118-74e76eaf6e48 | 2026-08-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | ce393bff-498b-42e6-a41c-bbfbc58fb42c | 2026-08-04 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 3b8662bf-3abb-4e54-af9c-5fa1d2e19003 | 2026-08-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Family Dollar Services Inc | 74ee96f7-75ac-4b60-a2b8-13b050e23804 | 2026-08-04 | Warnings | M012 |
| Mucus Relief PE | GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | cb1c1922-5dc6-520d-e77e-e951726d9701 | 2026-08-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | DOLGENCORP, LLC | 7a662caf-9cbb-4d55-b0b2-43f1f1289ec7 | 2026-08-04 | Warnings | M012 |
| Chest Congestion Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | DOLGENCORP, LLC | da053bc3-e790-4ae9-a406-2629640e97e7 | 2026-08-04 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 4d199dc7-253f-48fd-a77d-f8b10f724dd1 | 2026-08-04 | Warnings | M012 |
| daytime nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | 80aae1c3-a616-442b-842e-177db957a69c | 2026-08-04 | Warnings | M012 |
| Mucus Relief D | GUAIFENESIN, PSEUDOEPHEDRINE HCL | Meijer Distribution Inc | 383281d7-0d25-4423-ace2-d2985f2c37d0 | 2026-08-03 | Warnings | M012 |
| equaline daytime and nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 2026-08-03 | Warnings | M012 |
| Acetominophen, Dextromethorphan hydrobromide | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Softgel Healthcare Private Limited | 5302bc6d-d947-31c3-e063-6294a90a09f3 | 2026-08-03 | Warnings | M012 |
| MUCINEX INSTASOOTHE COUGH | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 0d99237c-0b52-0af6-e063-6394a90aba14 | 2026-08-03 | Warnings | M012 |
| daytime nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 182a105b-bd49-42b5-b4e0-46e5ec0197e3 | 2026-08-03 | Warnings | M012 |
| equaline nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 05e089e7-8772-4bf4-914f-6a26067ee719 | 2026-08-03 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Major Pharmaceuticals | 66b918d3-5c37-4889-b981-819ced8b6147 | 2026-08-03 | 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 |