topcare day time cold and flu relief
- Product NDC
- 36800-522
- 11-digit product format
- 368000522
- Labeler code
- 36800
- Product ID
- 36800-522_df6a549c-a593-42bb-9695-07a32df43c4c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2006-07-17
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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 | 36800-522 | 36800-522-38 | 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 | 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 relief
- Brand name suffix
- multi symptom relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1113705 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4 | 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 |
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 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 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 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 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-522-34 | 2026-01-29 | C162847 | 48780-1 | 49896155-c463-586f-e063-e6dba90add90 | Topco Associates LLC. Day Time Cold & Flu Relief Drug Facts |
| 36800-522-38 | 2026-01-29 | C162847 | 48780-1 | 49896155-c463-586f-e063-e6dba90add90 | Topco Associates LLC. Day Time Cold & Flu Relief Drug Facts |
| 36800-522-40 | 2026-01-29 | C162847 | 48780-1 | 49896155-c463-586f-e063-e6dba90add90 | Topco Associates LLC. Day Time Cold & Flu Relief Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-522-34 | topcare day time cold and flu reliefmulti symptom relief | 237 mL in 1 BOTTLE | SOLUTION | 237 | 12 | |
| 36800-522-38 | topcare day time cold and flu reliefmulti symptom relief | 296 mL in 1 BOTTLE | SOLUTION | 296 | 12 | |
| 36800-522-40 | topcare day time cold and flu reliefmulti symptom relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 12 | |
| 36800-522-40 | TopCare Day Time Nite Time Cold and Flu Relief | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 5 mg in 15mL | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-522 | TOPCARE DAY TIME COLD AND FLU RELIEF MULTI SYMPTOM RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC] | 11 | Current NDC, Legacy NDC, 3 package rows | 20241016_6d08ca2d-6ae4-443f-9920-34b7fb46f2b4.zip |
| 36800-522 | 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 |
|---|---|---|---|---|---|---|
| equaline nasal | OXYMETAZOLINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 07e0328e-1912-4f25-9e1e-9482d4665be0 | 2024-09-07 | Warnings | M012 |
| Benadryl Allergy EXTRA STRENGTH | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | dd0a8069-18d8-5696-e053-2995a90a2f22 | 2024-09-06 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | PAI Holdings, LLC | 88d0994c-4270-4408-8837-bd97510b2118 | 2024-09-06 | Warnings | M012 |
| QCH Maximum Strength Mucus Relief 617 | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association Inc. | a1c5c15e-0f3a-47d3-b9ed-1e0018417514 | 2024-09-06 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime Soft Chews | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 6ba64bbe-7599-406a-9187-737c0f8c1c2a | 2024-09-05 | Warnings | M012 |
| Cough Relief Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | 344282fc-3bd1-4f49-9bd1-08c5a58d1f73 | 2024-09-05 | Warnings | M012 |
| Equate Nasal | PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 95ef1819-edc3-4dda-8514-85b61538cc72 | 2024-09-04 | Warnings | M012 |
| Up and up nasal | OXYMETAZOLINE HYDROCHLORIDE | Target Corporation | 0c246c11-eadd-4ac6-bd58-5fdb151e06d6 | 2024-09-04 | Warnings | M012 |
| Exchange Select Nasal | OXYMETAZOLINE HYDROCHLORIDE | Army & Air Force Exchange Service | aafa9163-f08e-48c9-9ca1-7b72f67d007d | 2024-08-31 | Warnings | M012 |
| nasal 12 hour | OXYMETAZOLINE HYDROCHLORIDE | Meijer Distribution Inc | e9ee03db-a070-4c2b-ac61-7fd22bab2795 | 2024-08-31 | Warnings | M012 |
| dg health nasal | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | 42b58928-e8e5-49e4-b49e-498d77d64fcd | 2024-08-28 | Warnings | M012 |
| nasal mist | OXYMETAZOLINE HCL | CVS Pharmacy | b71c557a-eb93-40d1-87c4-847f5468fc1e | 2024-08-28 | Warnings | M012 |
| nasal | OXYMETAZOLINE HCL | Kroger Company | 0a24d98a-5950-49de-8b77-ea880b08d2c5 | 2024-08-28 | Warnings | M012 |
| basic care no drip nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | 96e018e2-e0b5-4802-a4a1-73a73d574082 | 2024-08-28 | Warnings | M012 |
| Topcare Nasal | OXYMETAZOLINE HCL | Topco Associates LLC | b5434599-5485-4949-9d76-b1ef3ad17c1a | 2024-08-28 | Warnings | M012 |
| basic care no drip nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | b15eb271-7842-495b-aa0f-9b20def86dc1 | 2024-08-28 | Warnings | M012 |
| Topcare Nasal | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | f1dd78e0-f700-4469-85d6-18cc299e8746 | 2024-08-28 | Warnings | M012 |
| equaline nasal | OXYMETAZOLINE HCL | United Natural Foods, Inc. dba UNFI | 69308693-a094-42a9-a041-e73647a25cc1 | 2024-08-27 | Warnings | M012 |
| signature care nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | f9ac80d1-3753-412b-a407-18a6b50e5d1c | 2024-08-27 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 20ac6010-84f4-eeff-e063-6294a90a50a7 | 2024-08-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4 | 12 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4 | 12 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4 | 12 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4 | 12 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4 | 12 |
| 2687211 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution) } Pack | GPCK | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 2687211 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution) Pack | PSN | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1042675 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution | PSN | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral Solution | PSN | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1042675 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 2604561 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SCD | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 2687211 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 mL Oral Solution) Pack | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1042675 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 2604561 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1042675 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1042675 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 2604561 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | c00ff684-acaf-4fbe-bc74-7e48751b927d | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-522-34 | 36800052234 | 237 mL in 1 BOTTLE (36800-522-34) | 237 ml | 2012-07-18 | 0000-00-00 | No | No | Current |
| 36800-522-38 | 36800052238 | 296 mL in 1 BOTTLE | 296 ml | Historical | ||||
| 36800-522-40 | 36800052240 | 355 mL in 1 BOTTLE (36800-522-40) | 355 ml | 2012-07-10 | 0000-00-00 | No | No | Current |