Topcare Day Time Cold and Flu
- Product NDC
- 36800-603
- 11-digit product format
- 368000603
- Labeler code
- 36800
- Product ID
- 36800-603_a3705566-c1ba-48f4-9ab4-67f8c4931a20
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-06-13
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- 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 | 36800-603 | 36800-603-34 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 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 Day Time Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| GUAIFENESIN | 200 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1369842 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-603-34 | Topcare Day Time Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | 9 | |
| 36800-603-40 | Topcare Day Time Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 9 | |
| 36800-603-40 | Topcare Day Time Nite Time Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 10 mg in 15mL | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-603 | TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241030_a88e5b8e-e6dd-4a1c-9628-5861d3205bdb.zip |
| 36800-603 | TOPCARE DAY TIME NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] | 7 | Current NDC, Legacy NDC | 20241116_aed387e0-5a8b-4caf-a373-3e04496a4983.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 |
|---|---|---|---|---|---|---|
| Berkley and Jensen Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | BJWC | c15b97a8-968f-4d38-905e-863e9fd16ce6 | 2026-01-06 | Warnings | M012 |
| Complete Allergy Medicine | DIPHENHYDRAMINE HCL | Salado Sales, Inc. | c0f5c8ca-b187-40bf-9245-6a29f1c32c97 | 2026-01-06 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | c5776b1e-9f72-4a6a-9961-8ac8e05b3249 | 2026-01-06 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | b9215a5e-3be8-44fd-9189-50dab760869c | 2026-01-06 | Warnings | M012 |
| Night Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Major Pharmaceuticals | f81efbf4-204b-45be-ae32-910d9e4ae4aa | 2026-01-06 | Warnings | M012 |
| SINUS AND NASAL DECONGESTANT | PSEUDOEPHEDRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d7646859-f996-46cd-a0b9-56b860f60901 | 2026-01-05 | Warnings | M012 |
| HyVee Cough Drops Honey Lemon | MENTHOL | HY-VEE, INC | 47a71cdf-856d-9ecd-e063-6294a90a70c6 | 2026-01-05 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Oncor Pharmaceuticals | fd35036c-b722-48a3-85fd-60471beb6e74 | 2026-01-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals,Inc. | 3c323dc8-f734-b44c-e063-6394a90a6184 | 2026-01-05 | Warnings | M012 |
| Congestion and Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | f43d97b1-aeb9-4ca5-8909-b28e7bf764f5 | 2026-01-05 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WinCo Foods, LLC | 6bd2b8fd-2023-413b-8988-a47d2058dc85 | 2026-01-05 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | WinCo Foods, LLC | 4c1046df-53a6-4219-83ac-bbf5cf4db9c8 | 2026-01-05 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 80323208-9ba5-432b-a8a0-0c0b51e67145 | 2026-01-05 | Warnings | M012 |
| Sinus Pressure and Pain PE Maximum Strength | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 347868e4-0182-4e16-895c-ec269895c57c | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Cherry | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | c5b11a9c-6d93-4772-93c2-1ef5c5647016 | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Honey Lemon | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | fae96736-1453-42fe-8158-cde770b23165 | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Menthol | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd | 2026-01-02 | Warnings | M012 |
| Reliable-1 Tussin | GUAIFENESIN | RELIABLE 1 LABORATORIES LLC | 2a33ff82-49df-7aaa-e063-6294a90a1281 | 2026-01-02 | Warnings | M012 |
| Tussin DMMax | DEXTROMETHORPHAN HBR, GUAIFENESIN | RELIABLE 1 LABORATORIES LLC | c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa | 2026-01-02 | Warnings | M012 |
| Severe Sinus Pain and Congestion Daytime | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7 | 2026-01-02 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | 10 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | 10 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | 10 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | 10 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | 10 |
| 2637731 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | aed387e0-5a8b-4caf-a373-3e04496a4983 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-603-34 | 36800060334 | 237 mL in 1 BOTTLE (36800-603-34) | 237 ml | 2014-06-22 | 0000-00-00 | No | No | Current |
| 36800-603-40 | 36800060340 | 355 mL in 1 BOTTLE (36800-603-40) | 355 ml | 2014-06-13 | 0000-00-00 | No | No | Current |