topcare nite time cold and flu relief
- Product NDC
- 36800-335
- 11-digit product format
- 368000335
- Labeler code
- 36800
- Product ID
- 36800-335_cb441ae0-196f-44d9-87b0-2f35facdd717
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-08-18
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- 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
- 2027-12-31
- 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 | 36800-335 | 36800-335-30 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 36800-335 | 36800-335-38 | 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 36800-335-38 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 36800-335-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 36800-335-38 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 36800-335-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 36800-335-38 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 36800-335-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 36800-335-38 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 36800-335-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 36800-335-38 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 36800-335-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 36800-335-38 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 36800-335-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 36800-335-38 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 36800-335-30 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 36800-335-38 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 36800-335-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 36800-335-38 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 36800-335-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 36800-335-38 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 36800-335-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 36800-335-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 36800-335-38 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 36800-335-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 36800-335-38 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
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 |
|---|---|
| 1043400 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 31210a95-f9dc-49db-aab5-25c4dca49266 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-335-30 | topcare nite time cold and flu relief | 177 mL in 1 BOTTLE | SOLUTION | 177 | 12 | |
| 36800-335-34 | topcare nite time cold and flu relief | 237 mL in 1 BOTTLE | SOLUTION | 237 | 12 | |
| 36800-335-38 | topcare nite time cold and flu relief | 296 mL in 1 BOTTLE | SOLUTION | 296 | 12 | |
| 36800-335-40 | topcare nite time cold and flu relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-335 | TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20241025_31210a95-f9dc-49db-aab5-25c4dca49266.zip |
| 36800-335 | TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] | 8 | Current NDC, Legacy NDC | 20241116_6cdc10f7-fd6e-4ea3-a466-97cb59b813f5.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 |
|---|---|---|---|---|---|---|
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 6ccbd537-2264-4b3c-804e-3d3ea5368a5f | 2025-09-05 | Warnings | M012 |
| Ephedrine Sulfate | EPHEDRINE SULFATE | Walgreen Company | dc0072f9-7111-1af0-e053-2a95a90aed56 | 2025-09-04 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS Pharmacy, Inc | 31aa77e0-cfdb-57a8-e063-6394a90af98c | 2025-09-04 | Warnings | M012 |
| Effervescent Orange Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | CVS Pharmacy, Inc. | 4bb70a55-de44-3dc1-e054-00144ff8d46c | 2025-09-04 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | CVS PHARMACY | a645b31e-7da7-4fe6-a04f-ac794ef52494 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de637b1-3402-db86-e063-6294a90ac981 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Medical Group Care LLC | f4a9cfec-0725-8f4a-e053-2995a90a1b4a | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de65c99-6c2d-3650-e063-6394a90aa98c | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE | Medical Group Care LLC | f4a9d879-4736-4f63-e053-2995a90adeba | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de66240-441c-00ad-e063-6294a90a4a05 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Medical Group Care LLC | ff99c57a-e06a-69d3-e053-6394a90a6775 | 2025-09-03 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS VITAMIN C SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de7ace0-e389-b751-e063-6394a90ab4e9 | 2025-09-03 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS VITAMIN C SUGAR-FREE | DISCOUNT DRUG MART | 06673358-1afc-4d75-e063-6394a90a6ab1 | 2025-09-03 | Warnings | M012 |
| ValuMeds Cough Relief, Dextromethorphan Hbr | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | b16a81db-d9bc-4cce-8ec2-dc189184931e | 2025-09-03 | Warnings | M012 |
| topcare day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 256d96f0-67bf-42d2-85ef-f49625c5910f | 2025-09-02 | Warnings | M012 |
| TOPCARE HONEY FLAVOR COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 2256623c-7642-4c39-b022-bfaecc861f1c | 2025-09-02 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | ef574f18-e28d-46bb-87fd-2f3b4df6dc68 | 2025-09-02 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kroger Company | f4429475-47f9-451a-bfcc-24b5ef333923 | 2025-09-02 | Warnings | M012 |
| dg health night time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1 | 2025-08-29 | Warnings | M012 |
| MGC Health Cough Drops Original Herb | MENTHOL | Medical Group Care LLC | 3d70ba70-eb11-f148-e063-6294a90a4c7c | 2025-08-28 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 31210a95-f9dc-49db-aab5-25c4dca49266 | 12 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 31210a95-f9dc-49db-aab5-25c4dca49266 | 12 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 31210a95-f9dc-49db-aab5-25c4dca49266 | 12 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 31210a95-f9dc-49db-aab5-25c4dca49266 | 12 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 31210a95-f9dc-49db-aab5-25c4dca49266 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-335-30 | 36800033530 | 177 mL in 1 BOTTLE | 177 ml | Historical | ||||
| 36800-335-34 | 36800033534 | 237 mL in 1 BOTTLE (36800-335-34) | 237 ml | 2012-07-17 | 0000-00-00 | No | No | Current |
| 36800-335-38 | 36800033538 | 296 mL in 1 BOTTLE | 296 ml | Historical | ||||
| 36800-335-40 | 36800033540 | 355 mL in 1 BOTTLE (36800-335-40) | 355 ml | 2012-07-16 | 0000-00-00 | No | No | Current |