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 | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | ca3c1eb4-6099-5e5f-e053-2995a90ab61b | 2026-01-19 | Warnings | M012 |
| SEVERE NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREENS | fe6dff90-18f1-491e-84b9-cc74bb1831ba | 2026-01-19 | Warnings | M012 |
| Daytime Non-Drowsy Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens Company | ec8c73d5-b190-432a-92c6-68ea0fc86ea6 | 2026-01-19 | Warnings | M012 |
| Walgreens NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | WALGREEN COMPANY | 5bf72e2f-15c8-466a-9e13-50654233da91 | 2026-01-19 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | 9862f84d-1c18-4ef7-86dc-98572599d417 | 2026-01-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 37853689-c9ca-4bc7-9c5b-4a68b8d778be | 2026-01-19 | Warnings | M012 |
| VAPORX | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | AKRON PHARMA INC | 51b32162-0c5a-4b5b-999a-34337d816603 | 2026-01-19 | Warnings | M012 |
| Equate | OXYMETAZOLINE HCL | Walmart Inc | 2f762c24-2442-506a-e063-6394a90a3b96 | 2026-01-19 | Warnings | M012 |
| Dimetane | DIPHENHYDRAMINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 2026-01-19 | Warnings | M012 |
| nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | f681d986-9838-42d8-8ed9-732a39fbf870 | 2026-01-19 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | H E B | 22d241c5-a3fd-4619-8147-91d7a4c8cf98 | 2026-01-19 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | Better Living Brands, LLC | 9fe63ca6-3863-4175-9aec-ecd6ebbdb249 | 2026-01-19 | Warnings | M012 |
| Good Neighbor Pharmacy Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | 5749ce9d-e182-478f-ab88-b520a35a99a7 | 2026-01-19 | Warnings | M012 |
| Foster and Thrive Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Strategic Sourcing Services LLC | 1d9150b1-2f6c-4c33-8c93-3ed1d88585e2 | 2026-01-18 | Warnings | M012 |
| HealthWise Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | ce3ceffd-3ff5-3795-e053-2995a90a827f | 2026-01-18 | Warnings | M012 |
| topcare nite time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Topco Associates LLC | 31210a95-f9dc-49db-aab5-25c4dca49266 | 2026-01-17 | Warnings | M012 |
| Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f77226c0-b6d5-9fd0-e053-6294a90a4b57 | 2026-01-16 | Warnings | M012 |
| Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f691734b-5cf4-6eb8-e053-2a95a90aee80 | 2026-01-16 | Warnings | M012 |
| Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f771aa19-295a-9f4e-e053-6294a90a1674 | 2026-01-16 | Warnings | M012 |
| CVS Cherry Cough Drops | MENTHOL | CVS Pharmacy | de5c4b94-0420-5d43-e053-2995a90aa5a5 | 2026-01-16 | 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 |